} ?>
SDIC Securities Co., Ltd
About Sichuan Baili Tianheng Pharmaceutical Co., Ltd
2024 Semi-Annual Continuous Supervision Follow-up Report
SDIC Securities Co., Ltd. (hereinafter referred to as "SDIC Securities" or "Sponsor") as Sichuan
The initial public offering of Baili Tianheng Pharmaceutical Co., Ltd. (hereinafter referred to as "Baili Tianheng" or the "Company").
Sponsors whose stocks are listed on the STAR Market in the continuous supervision stage shall be subject to the "Management of Sponsor Business for Securities Issuance and Listing".
Administrative Measures", "Rules for the Listing of Stocks on the Science and Technology Innovation Board of the Shanghai Stock Exchange", "Listed Companies on the Shanghai Stock Exchange".
Legal Regulatory Guidelines No. 11 - Continuous Supervision" and other relevant laws and regulations, to fulfill the provisions of Baili Tianheng
The report on the 2024 semi-annual continuous supervision and follow-up of Baili Tianheng is as follows:
1. Continue to supervise the work
Serial No. Work Content Continuous supervision
Establish a sound and effective implementation of the continuous supervision system, and the sponsor institution has established, improved and effectively implemented the continuous supervision work
1. Formulate a corresponding work system and a corresponding work plan for specific continuous supervision work.
Plan.
According to the relevant regulations of the China Securities Regulatory Commission, the sponsor has signed a sponsorship agreement with Baili Tianheng in the continuous supervision of the work, and the agreement is clear
2. Before the commencement, sign with the listed company or relevant parties to continue the rights and obligations of both parties during the continuous supervision period, and report to Shanghai
A supervision agreement that clarifies the rights of both parties during the period of continuous supervision of the stock exchange filing.
obligations, and reported to the Shanghai Stock Exchange for the record.
During the period of continuous supervision, in accordance with the relevant regulations, the listed company violated the Baili Tianheng from January 1, 2024 to June 30, 2024
3. If a public statement is made on the violation of the law, it shall not be reported during the period before disclosure (hereinafter referred to as the "continuous supervision period").
Violations of laws and regulations reported by the Shanghai Stock Exchange and required by the sponsor to make a public statement in accordance with the relevant regulations of the Shanghai Stock Exchange
After the review, it will be announced in the designated media. Condition.
During the period of continuous supervision, the listed company or related parties appear
Violations of laws and regulations, breach of commitments and other matters shall be discovered by themselves
4 Within five working days from the date of discovery, it should be reported to Shanghai Securities During the period of continuous supervision, Baili Tianheng and related parties did not occur
Exchange report, the content of the report includes the listed company or related matters that need to be reported for violations of laws and regulations or breach of commitments.
The parties have violated laws and regulations, violated commitments, and other matters
situation, the supervisory measures taken by the sponsor, etc.
Through daily communication, regular return visits, on-site inspections, and continuous supervision of due diligence, the sponsor institution is uncertain through daily communication
5. Carry out continuous supervision through investigation and other means. Return visits, on-site inspections, etc., to understand the operation of Baili Tianheng
standardize the operation and other conditions, and carry out continuous supervision of Baili Tianheng.
Supervise the listed company and its directors, supervisors and senior managers During the period of continuous supervision, the sponsor supervises Baili Tianheng and its superiors
6. Abide by laws, regulations, departmental rules and directors, supervisors and senior managers of Shanghai Securities Exchange to comply with laws, regulations and departments
Business rules and other normative documents issued by E-Exchange, and business rules and regulations issued by the Shanghai Stock Exchange and others
Earnestly implement the commitments it has made. normative documents, and earnestly fulfill the commitments they have made.
7. Supervise the listed company to establish, improve and effectively implement corporate governance During the period of continuous supervision, the sponsor shall supervise Baili Tianheng in accordance with it
management system, including but not limited to the general meeting of shareholders, the board of directors, and relevant regulations, improve and improve the corporate governance system, and strictly implement the regulations
Rules of Procedure of the Board of Supervisors and Corporate Governance System for Directors, Supervisors and Senior Management.
Code of conduct for personnel, etc.
Supervise listed companies to establish, improve and effectively implement internal controls
including but not limited to financial management system and accounting
8 system and internal audit system, as well as the use of raised funds, During the period of continuous supervision, the internal control system of Baili Tianheng is in line with the relevant regulations
The requirements of laws and regulations on related party transactions, external guarantees, foreign investment, and derivatives transactions have been effectively implemented.
Procedures for major business decisions such as control of subsidiaries
with rules, etc.
Supervise listed companies to establish, improve and effectively implement information disclosures
Disclosure system, review of information disclosure documents and other relevant documents During this continuous supervision period, the sponsor supervises Baili Tianheng strictly
9 cases, and there are sufficient reasons to believe that the listed company implements the information disclosure system to the Shanghai Securities and reviews its information disclosure to the Shanghai Stock Exchange
The documents submitted by the exchange do not contain false records or misleading information disclosure documents.
Statements or material omissions.
Information disclosure documents for listed companies and to the China Securities Regulatory Commission
and other documents submitted by the Shanghai Stock Exchange
Review before and supervise the problematic information disclosure documents in a timely manner
urge the company to correct or supplement, and the company will not correct or supplement
shall report to the Shanghai Stock Exchange in a timely manner; During the period of continuous supervision, the sponsor has information on Baili Tianheng
10. If the information disclosure documents of the municipal company have not been reviewed in advance, the disclosure documents have been reviewed, and the listed company will not correct them
The situation should be reported to the Shanghai Stock Exchange in a timely manner after the listed company fulfills its information disclosure obligations.
Within a few days, complete the review of the relevant documents and save them
The information disclosure documents in question should be supervised in a timely manner
The company shall correct or supplement, and the listed company shall not correct or supplement
shall report to the Shanghai Stock Exchange in a timely manner.
Pay attention to listed companies or their controlling shareholders and actual controllers,
Directors, supervisors and senior management personnel are subject to the continuous supervision of the China Securities Regulatory Commission During this period, Baili Tianheng and its controlling shareholders and actually
11. No administrative punishment, disciplinary action of the Shanghai Stock Exchange, or the controlled person, director, supervisor, or senior management has occurred
The Shanghai Stock Exchange issued a letter of regulatory concern, and the matter.
Supervise and urge them to improve the internal control system and take measures to rectify it
Correct.
Continue to pay attention to listed companies, their controlling shareholders and actual controllers
12 and other fulfillment of commitments, listed companies and controlling shareholders, during the period of continuous supervision, Baili Tianheng and its controlling shareholders, actually
If the actual controller fails to fulfill the commitment, the controller and others shall promptly report to the controller that there is no failure to fulfill the commitment.
Report of the Sea Stock Exchange.
Pay attention to social media reports and rumors about listed companies,
Conduct timely verification of market rumors. It was found after verification
The listed company has material matters that should be disclosed and not disclosed or During the period of continuous supervision, after verification by the sponsor, Baili Tianheng does not
13. If the disclosed information is inconsistent with the facts, it shall promptly supervise the existence of material matters that should be disclosed but not disclosed, or the information and things that should be disclosed
The municipal company truthfully discloses or clarifies it; The listed company does not conform to the facts.
If it is disclosed or clarified, it shall be reported to the Shanghai Stock Exchange in a timely manner
Tell.
14 If one of the following circumstances is found, the listed company shall be urged to make a statement During the period of continuous supervision, no relevant situation occurred in Baili Tianheng.
Clarify and make corrections within a time limit, and report to the Shanghai Stock Exchange at the same time
(1) Suspected breach of the Listing Rules by the listed company
and other relevant business rules of the Shanghai Stock Exchange; (2) Certificates
Professional opinions issued by the securities service agency and its signatories
There may be misrepresentations, misleading statements, or material omissions
and other violations of laws and regulations or other improper circumstances; (c) above
The municipal company appeared in the "Securities Issuance and Listing Sponsorship Business Management Office".
the circumstances provided for in Articles 71 and 72 of the Law;
(4) The listed company does not cooperate with the sponsor to continue to supervise the work
Make; (5) In the opinion of the Shanghai Stock Exchange or the sponsoring institution
Other circumstances that need to be reported.
Formulate a work plan for the on-site inspection of the listed company, and make it clear that the sponsor has formulated the relevant work plan for the on-site inspection, and
15. On-site inspection work requirements to ensure the quality of on-site inspection work The on-site inspection work requirements are clarified.
Measure.
In the event of any of the following circumstances in a listed company, the sponsor institution,
The sponsor representative shall know or should have known from the date on which he or she should have known
Special on-site verification shall be carried out within 15 days: (1) exists
suspicion of major financial fraud; (2) Controlling shareholder and actual
The controller and its affiliates are suspected of misappropriation of funds; (3) During the period of continuous supervision, Baili Tianheng should be carried out in a special manner
16. There can be a guarantee of material violations; (4) The controlling shareholder and the relevant circumstances of the on-site inspection.
international controllers and their affiliates, directors, supervisors or senior officers
management personnel are suspected of misappropriating the interests of listed companies; (5) Resources
There is a material abnormality in the cash flow or cash flow; (5) above
The Shanghai Stock Exchange or the sponsor institution deems it necessary to carry out the listing
Other matters to be verified on the spot.
2. Problems found by the sponsor and the sponsor representative and their rectification
During this period of continuous supervision, the sponsor and the sponsor representative did not find any major problems with the company.
3. Major risk warning
During the period of continuous supervision, the Company's key risk issues are as follows:
(1) Core competitiveness risks
The development and commercialization of new drugs, especially biologics, is highly competitive. Companies are faced with the challenges of being drawn from all over the globe to its
He is competing with pharmaceutical and biopharmaceutical companies, and there are a number of large pharmaceutical and biopharmaceutical companies currently marketing and selling
Drugs or are seeking to be developed for the treatment of drugs with the same indication that the company is developing. competitor
Competitors may be discovered, developed, or commercialized faster or more successfully than the Company, or developed by competitors
and commercialized drugs that are safer, more effective, more convenient or less expensive than drugs that the Company may develop or commercialize
The business opportunities of the company may be drastically reduced or even disappear.
The company recruits and retains qualified scientific, clinical, manufacturing, and sales and marketing personnel
The R&D and commercialization of innovative drugs are crucial. The company's senior management, core technical personnel and others
The loss of key employees can hinder the achievement of a company's R&D and commercialization goals and undermine a company's ability to successfully implement its business strategy.
There is a risk that the Company will not be able to successfully or timely complete clinical development, regulatory approval and commercialization of its drugs. The success of the Company's drugs and drug candidates depends on a number of factors, including preclinical studies, successful enrollment of patients to complete clinical trials, and approval of safety and efficacy data from clinical trials; The Company's development activities, regulatory filings, and production operations are not hindered or delayed; Successfully launched the company's drugs and drug candidates (if approved) and successfully launched sales promotion; Continuing to guarantee acceptable safety after regulatory approvals have been obtained, etc. The Company's inability to achieve or maintain one or more of the foregoing factors that result in the Company's failure to successfully or timely obtain regulatory approvals and complete the commercialization of drugs and drug candidates could materially damage the Company's business and future earnings.
(2) Business risks
After the company's new drug research and development is successful, it needs to go through the process of market development and academic promotion to achieve good sales of drugs. After the approval of the company's drug candidates, if the progress in market access, market expansion and academic promotion does not meet expectations, resulting in the inability to quickly increase the volume or effectively obtain the approval of doctors or patients, it may affect the company's revenue growth and profitability.
The company's business operations require a large number of raw materials and consumables, such as raw materials and starting materials for production, laboratory reagents, consumables, glassware, accessories and packaging materials. If the prices of raw materials and consumables rise significantly, there is no guarantee that the Company will be able to increase the price of marketed drugs after commercialization to compensate for the cost increase, and the Company's profitability may be adversely affected.
The continued operation and safety of the Company's production facilities may be subject to significant disruption and material adverse effects due to a number of factors, including fire, flood, earthquake, power outage, fuel shortage, mechanical failure, terrorist attacks and war or other natural disasters, as well as expiration of land use rights, lack of licenses, certificates and permits, changes in government planning and regulatory changes for the land associated with such facilities or their surrounding areas.
(3) Financial risks
As of June 30, 2024, all innovative drug candidates are in clinical and preclinical development. With the steady progress of the company's R&D projects, R&D expenditure will continue to increase in the future. And during the reporting period
The Company's primary source of revenue, other than traditional medicine revenue, is the March 2024 payment by BMS to the Company
Refundable and non-deductible down payment. Under the agreement with BMS, the company could receive up to $500 million in immediate contingent payments; Companies can achieve up to certain development, registration and sales milestones
$7.1 billion in milestone payments.
The Company's business and prospects are highly dependent on the success of its drug candidates, including BL-B01D1.
The Company's business and prospects could be materially and adversely affected by the failure to successfully complete the clinical development, regulatory approval or commercialization of the drug, or to experience significant delays or cost overruns in any of the foregoing.
With the steady progress of the company's internationalization, the company's operating results and cash flow are affected by fluctuations in foreign exchange rates, which may expose the company to foreign exchange risks. The value of RMB against the US dollar, Hong Kong dollar and other currencies may be affected by changes in global political and economic conditions, and although the Company can make reasonable use of foreign exchange tools to mitigate the impact of exchange rate fluctuations, it is still unavoidable that future foreign exchange fluctuations may adversely affect the Company's financial condition, results of operations and cash flows.
(4) Industry risks
The pharmaceutical industry is one of the key industries in China, and pharmaceutical products are special consumer goods related to people's life, health and safety; At the same time, the pharmaceutical industry is also a highly regulated industry, and its regulatory authorities include national and local drug regulatory departments and health departments at all levels, which formulate relevant policies and regulations within their respective jurisdictions to supervise the entire industry. China is currently in a period of economic restructuring, and various reforms are gradually deepening. With the deepening of China's medical and health system reform and the gradual improvement of the social medical security system, industry-related regulatory policies will continue to improve and adjust, and the policy environment of China's medical and health market may face major changes. If the company fails to adjust its business strategy in a timely manner to adapt to the changes in market rules and regulatory policies brought about by the reform of the medical and health system, it will have an adverse impact on the company's operation.
(5) Macro environmental risks
As a company with R&D centers in China and the United States, the Company and its subsidiaries are required to comply with the relevant laws and regulations that may be issued or amended from time to time by the international and regional legislatures, government departments or other regulatory authorities involved in the company's place of incorporation and production and business activities, which may have a material impact on the Company or its subsidiaries. In addition, the uncertainty of the international political, economic and market environment in the future may also have a certain adverse impact on the company's overseas business operations.
4. Major violations
During the period of continuous supervision, the company did not have any major violations.
5. Reasons and reasonableness of changes in major financial indicators
From January to June 2024, the company's main accounting data are shown in the following table:
Unit: Yuan
Item January-June 2024 January-June 2023 Increase/Decrease (%)
Operating income 5,552,727,531.48 311,043,872.56 1,685.19
Net profit attributable to shareholders of the listed company 4,666,340,011.27 -328,319,054.04 Not applicable
Deductions attributable to shareholders of listed companies are not applicable to non-4,644,208,923.71 -331,475,164.39
Net profit from recurring gains or losses
Net cash flow from operating activities 5,028,680,661.05 -323,055,782.91 Not applicable
Item June 30, 2024 December 31, 2023 Change (%)
Net assets attributable to shareholders of listed companies 4,828,575,695.35 151,873,300.02 3,079.34
Total assets 7,185,693,617.61 1,425,099,282.62 404.22
From January to June 2024, the company's main financial indicators are shown in the following table:
Item January-June 2024 January-June 2023 Increase/Decrease (%)
Basic earnings per share (RMB/share) 11.64 -0.82 Not applicable
Diluted earnings per share (RMB/share) 11.64 -0.82 Not applicable
Basic earnings per share after non-recurring gains and losses were 11.58 -0.83 N/A
Profit (RMB/share)
Weighted average return on equity (%) 187.78 -42.65 N/A
Weighted average net 186.89 -43.06 net after non-recurring gains and losses N/A
Return on Assets (%)
Ratio of R&D investment to operating income (%) 9.81 107.00 decreased by 97.19 percentage points
From January to June 2024, the reasons for the changes in the company's main financial data and indicators are as follows:
1. From January to June 2024, the company's operating income increased by 1,685.19% over the same period of the previous year, mainly in 2024
In March, the company received the first cooperation agreement based on BL-B01D1 from BMS, an overseas partner and a global multinational pharmaceutical company
payment, and recognized the license fee income of 533,172.42 million yuan in accordance with the performance terms agreed in the contract.
2. From January to June 2024, the company's net profit attributable to shareholders of listed companies and shares attributable to listed companies
Dong's net profit after deducting non-recurring gains and losses increased by 499,465.91 million yuan and the same period last year, respectively
497,568.41 million yuan, mainly due to the receipt of the down payment from BMS, and the recognition of license fee income of 5331.7242 million yuan,
As a result, the company's profit for the current period increased significantly.
3. From January to June 2024, the company's net cash flow from operating activities increased compared with the same period last year
is due to an increase in cash received for the sale of goods and services resulting from the receipt of a down payment from the BMS.
4. At the end of June 2024, the company's net assets attributable to shareholders of listed companies increased compared with the end of the previous year
3,079.34%, mainly due to the increase in net profit.
5. At the end of June 2024, the company's total assets increased by 404.22% compared with the end of the previous year, mainly due to the receipt of BMS
Down payment, due to the increase in the company's monetary funds.
6. From January to June 2024, the company's basic earnings per share, diluted earnings per share, and non-recurring gains and losses were deducted
The subsequent increase in basic earnings per share over the same period last year was mainly due to the increase in net profit.
7. From January to June 2024, the company's weighted average return on equity, after deducting non-recurring gains and losses
The increase in average return on equity over the same period last year was mainly due to the increase in net profit.
8. From January to June 2024, the proportion of the company's R&D investment in operating income decreased by 97.19 compared with the same period last year
The percentage point was mainly due to the significant increase in operating income in the current period.
In summary, the changes in the company's main financial data and financial indicators in the first half of 2024 are reasonable.
Sixth, the changes in core competitiveness
After years of development, the company has formed a two-wheel drive pipeline pattern of high-end chemical drugs and innovative biological drugs represented by new anti-tumor bi/polyclonal antibodies. The company has a high proportion of R&D personnel, high investment in R&D funds, has global rights and interests and completely independent intellectual property rights of the innovative biopharmaceutical core technology platform, has strong technological innovation capabilities and long-term rapid development potential, in line with the industry development trend and the national innovation-driven development strategy, the company's core competitiveness is as follows:
(1) The model of dual R&D centers in China and the United States, combining "0 to 1" breakthrough innovation and "1 to 100" high
Efficiency follow-up development capabilities
The company has R&D centers in United States and China. For the R&D of innovative drugs, the North American innovation ecosystem has the significant advantage of "0 to 1" breakthrough innovation, and the Chinese ecosystem is particularly efficient in terms of "1 to 100" large-scale innovation. In 2014, the company established a wholly owned subsidiary, SystImmune, in United States Seattle to lead the discovery of the company's "0-to-1" stage of innovative therapies and new drug pipelines, as well as global clinical development and future commercialization of product candidates in the global market. At the same time, the company's R&D team leverages "China efficiency" to scale and accelerate translational medicine, preclinical development, and early clinical proof-of-concept. With the dual R&D center model built in United States and China, the company has formed a new drug R&D technology platform with independent intellectual property rights, providing a strong guarantee for continuous innovation. With this visionary initiative, the company has established a world-class "end-to-end" ADC and multi-specific antibody innovation and development capability and competitive advantage.
The company's R&D teams in China and the United States include both excellent scientists trained and grown up within the company
Excellent professionals brought in from the industry. As of June 30, 2024, the company's research and development in China and the United States
The team has a total of 879 members, which is about 38.83% of the company's total number of employees. The R&D team has 56 people with doctoral degrees and 165 people with master's degrees. The company's R&D team is comprised of individuals with extensive experience in drug discovery, preclinical development, CMC, clinical development, and regulatory affairs, covering the entire R&D cycle of innovative drugs. Many of them have worked in leading multinational corporations and domestic biopharmaceutical companies, well-known research institutes (e.g
UT MD Anderson Cancer Center and Fred Hutchinson Cancer Research Center) and
FDA's years of experience leading drug discovery and development programs.
(2) Focusing on the field of oncology, it has the world's leading and completely independent intellectual property rights of the core technology platform of innovative drugs and sustainable innovation capabilities
After years of technological innovation and accumulation, the company has built a world-leading innovative ADC drug R&D platform (HIRE-ADC platform) with global rights and completely independent intellectual property rights, a world-leading innovative multi-specific antibody drug R&D platform (GNC platform), and a specificity-enhanced bispecific antibody platform (SEBA platform).
As of June 30, 2024, the company has applied for a total of 562 invention patents, including 126 in China
, 48 in the United States, 9 under the Patent Cooperation Treaty (PCT) and 379 in other jurisdictions; cumulation
Obtained 137 invention patents, including 69 in China, 11 in the United States and 57 in other jurisdictions.
The above-mentioned core technology platform and patent protection have built the company's comparative advantage in the industry and laid the foundation for the company to maintain long-term sustainable competitiveness.
(3) It has a world-leading and globally competitive potential superblockbuster drug and a rich drug research and development pipeline
After years of continuous R&D investment, the company has built a rich type of products and pipelines under development
System. As of the disclosure date of the company's 2024 semi-annual report, the company has successfully developed 3 phase III clinical assets (its
2 ADC agents and 1 bispecific antibody drug), 10 early-stage core clinical assets (5 of which ADCs
drugs, 4 GNC drugs and 1 bispecific antibody drug) and a department based on the core technology platform of innovative drugs
Listed as assets of preclinical innovative drug projects under development.
The pipeline includes EGFR×HER3 bispecific antibody ADCs that are in the global clinical stage, first-and-only
(BL-B01D1), and 4 first-and-only to date that have entered the global clinical phase or IND stage
of multispecific antibodies.
(4) It has the ability to develop and commercialize the whole industry chain from R&D to independent production and commercialization
In terms of innovative drug production, as of June 30, 2024, DotBio's base has been in accordance with cGMP standards
It has established an early stage commercial life that can meet the needs of clinical sample production of innovative biologics and after approval for marketing
Production of antibody/ADC drug production facilities, including cell culture plants (with a capacity of 6 x 2,000 liters
bioreactor and 1 x 1,000 liter bioreactor), purification workshop, ADC conjugation workshop, and 1 formulation
The line is used for filling/lyophilization of finished product preparations. The current production capacity of DotBio's base is capable of supporting IND applications, clinical trials and future commercialization of the Company's pipeline candidates. Based on the progress of pipeline drug development, in order to further support the late-stage clinical trials and future commercialization of the company's innovative drugs, the company is rigorously evaluating the expansion of DotBio's base, and plans to establish a new production facility to facilitate the production of ADC drug conjugation and lyophilized powder injection in the pipeline.
In terms of generic drug production, the company has strategically established a "API-finished drug" generic drug and proprietary Chinese medicine production platform through the synergies between the three bases of Guorui Base (injection and oral preparation), Baili Base (oral solid preparation and lyophilized powder for injection), and Hayate/Jingxi Base (intermediates and chemical APIs). The production platform integrates the production process from raw materials to finished products, ensuring continuous and sufficient supply of commercial sales of products already on the market.
At the same time, the company has complete commercialization capabilities. As of the disclosure date of the company's 2024 semi-annual report, the company has established a comprehensive commercialization system covering more than 30 provinces, autonomous regions and municipalities directly under the central government and more than 200 cities across the country, ensuring that the company's commercial products reach all major markets and cities, counties and towns. The company's professional commercialization team has strong sales capabilities and rich experience to support system planning and efficient network operation. According to the differences in product sales channel terminals and marketing entities, the company is divided into direct sales model and distribution model; At the same time, in order to achieve in-depth and professional marketing of specialized products and specialized markets, the sales team implements the division system, and different business divisions are responsible for the promotion of different products and products under different sales channels. The company's commercialization infrastructure and dedicated sales team effectively meet the needs of different market segments, including the prescription and over-the-counter markets, enabling the company to continuously strengthen its established product brands and increase the market penetration of its products in the prescription and over-the-counter markets.
In summary, the company's core competitiveness has not undergone adverse changes in the first half of 2024.
7. Changes in R&D expenditure and R&D progress
(1) R&D expenditure and changes
The company's R&D investment is as follows:
Unit: Yuan
Project January-June 2024 January-June 2023 Increase or decrease (%)
Expensed R&D investment 544,530,631.66 332,829,337.19 63.61
Capitalized R&D investment - - -
Total R&D investment 544,530,631.66 332,829,337.19 63.61
Ratio of total R&D investment to operating income (%) 9.81 107.00 decreased by 97.19 percentage points
Proportion of capitalization of R&D investment (%) - - -
From January to June 2024, the company's R&D investment was 544.5306 million yuan, an increase of 21,170.13 over the same period last year
10,000 yuan, an increase of 63.61%, mainly due to the increase in the remuneration of the company's R&D personnel, the continuous advancement of new drug R&D progress, and the increase in R&D investment such as test and inspection fees and material costs.
(2) R&D results obtained during the reporting period
1. The company's innovative biological drug research projects and their progress
(1) As of the disclosure date of the company's 2024 semi-annual report, the company is in the clinical research stage or IND filing
The overall progress of the core innovative biologics pipeline in the stage is shown in the following chart:
Note: The clinical progress in the figure above refers to the trial stage with the fastest R&D progress of the corresponding product.
(2) As of the disclosure date of the Company's 2024 semi-annual report, the clinical research and progress of BL-B01D1 have been carried out
As shown in the figure below:
Note 1: Refers to United States clinical trials.
2. The company's main high-end chemical drug research projects and their progress
From January to June 2024, the company's three products, linezolid, structural triglycerides, and nicorandil, obtained chemicals
API marketing approval; Four products, namely Urapidil Hydrochloride Injection, Linezolid Glucose Injection, Structural Fat Emulsion Injection (C6~24) and Azithromycin Dry Suspension, have obtained drug registration certificates; In addition, there are 2 specifications of medium/long chain fat emulsion injection (C6~24) to obtain the approval notice of drug supplement application (through consistency evaluation);
5 specifications of propofol medium/long chain fat emulsion injection, 4 specifications of azithromycin granules, and 1 granule of ammonia
The specifications have obtained the approval notice of drug re-registration application.
3. Clinical approval/clinical trial notice/drug approval
From January to June 2024, the company obtained 13 clinical approvals and 19 registration approvals, as follows:
Compilation Product Name Specification Approval Type Notice/Certificate Issuance Time
No. Number
1 BL-M05D1 for injection / Notice of approval of clinical trial 2024LP00616 3/11/2024
2 BL-M07D1 for injection / Notice of approval of clinical trial 2024LP00810 4/1/2024
3 BL-M07D1 for injection / Notice of approval of clinical trial 2024LP00811 4/1/2024
4 BL-B01D1 for injection / Notice of approval for clinical trial 2024LP00973 4/19/2024
5 BL-B01D1 for injection / Notice of approval for clinical trial 2024LP01033 4/26/2024
6 BL-B01D1 for injection / Notice of approval of clinical trial 2024LP01034 4/26/2024
7 BL-B01D1 for injection / Notice of approval of clinical trial 2024LP01035 4/26/2024
8 BL-B01D1 for injection / Notice of approval of clinical trial 2024LP01036 4/26/2024
9 BL-B01D1 for injection / Notice of approval of clinical trial 2024LP01037 4/26/2024
10 BL-B01D1 for injection / Notice of approval of clinical trial 2024LP01038 4/26/2024
11 BL-B01D1 for injection / Notice of approval of clinical trial 2024LP01039 4/26/2024
12 BL-B16D1 for injection / Notice of approval for clinical trial 2024LP01118 5/8/2024
13 BL-M17D1 for injection / Notice of approval of clinical trial 2024LP01406 6/21/2024
14 Linezolid / Chemical API Marketing Application 2024YS00256 3/27/2024
Notice of Approval
15 Structural triglycerides, Chemical API Marketing Application 2024YS00291 4/9/2024
Notice of Approval
16 Urapidil hydrochloride injection 5ml: 25mg Drug Registration Certificate 2024S00586 4/17/2024
17 Linezolid Glucose Injection 300ml Drug Registration Certificate 2024S00691 4/24/2024
liquid
18 Structural Fat Emulsion Injection 250ml Drug Registration Certificate 2024S01144 6/11/2024
(C6~24)
19 Nicorandil API Chemical API NDA 2024YS00594 2024/6/27
Notice of Approval
20 Azithromycin Dry Suspension 0.1g Drug Registration Certificate 2024S01460 6/28/2024
21 Medium/Long Chain Fat Emulsion Injection 100ml Drug Supplement Application Approval 2024B00398 2024/1/25
(C6~24) Zhishu
22 Medium/Long Chain Fat Emulsion Injection 250ml Drug Supplement Application Approval 2024B00399 2024/1/25
(C6~24) Zhishu
23 Propofol medium/long chain fat emulsion 20ml, drug re-registration application approval 2024R002513 2024/3/22
Injection 0.2g notification
24 Propofol medium/long chain fat emulsion 50ml, drug re-registration application approval 2024R002515 2024/3/22
Injection 0.5g notification
25 Propofol medium/long chain fat emulsion 10ml, Drug Re-registration Application Approval 2024R002512 2024/3/22
Notification of injection 0.1g
26 Propofol medium/long chain fat emulsion 100ml, drug re-registration application approval 2024R002514 2024/3/22
Injection 1.0g notification
27 Propofol medium/long chain fat emulsion 20ml, 0.1g Drug re-registration application approval 2024R002511 2024/3/22
Injection Notice
28 Azithromycin granules 0.125g Drug Re-registration Application Approval 2024R003489 4/24/2024
notice
29 Azithromycin granules 0.1g Drug Re-registration Application Approval 2024R003490 2024/4/24
notice
30 Azithromycin granules 0.25g Drug Re-registration Application Approval 2024R003491 2024/4/24
notice
31 Azithromycin granules 0.5g Drug Re-registration Application Approval 2024R003492 2024/4/24
notice
32 Ammonia Jinhuangmin Granules 5g Drug Re-registration Application Approval 2024R005330 2024/6/14
notice
4. Intellectual property rights
As of June 30, 2024, the Company and its subsidiaries had a total of 261 authorized intellectual property rights. Among them, hair
There are 137 patents, including 69 domestic patents, 11 United States patents and 57 patents in other jurisdictions
Item. The list of intellectual property rights acquired during the reporting period is as follows:
Cumulative number of new additions in this period
Number of applications (pcs) Number of acquisitions (pcs) Number of applications (pcs) Number of acquisitions (pcs)
Invention patents 91 14 562 137
Utility model patents - - 44 44
Design patents - - 61 23
Software Copyright - - - -
Other - - 57 57
Total 91 14 724 261
8. Whether the progress of the new business is consistent with the information disclosed in the previous period
To accelerate the global clinical development program of BL-B01D1 for multiple cancers, the Company is a wholly owned subsidiary
SystImmune has entered into an exclusive licensing agreement with BMS for the BL-B01D1 project. February 8, 2024
The above-mentioned cooperation agreement officially came into effect. From January to June 2024, the company received the BMS based on BL-B01D1 combination
The down payment of the agreement was made, and the license fee income of 533,172.42 million yuan was recognized according to the performance terms agreed in the contract, resulting in an increase of 1,685.19% in the company's operating income for the current period compared with the same period last year.
The Company has fulfilled its obligation to disclose information on the follow-up progress of the above-mentioned cooperation agreement in a timely manner, please refer to the details for details
The Company disclosed on December 12, 2023, February 19, 2024, and March 11, 2024, respectively
"Sichuan Baili Tianheng Pharmaceutical Co., Ltd. Announcement on the Global Strategic Cooperation Agreement between SystImmune, a Wholly-owned Subsidiary, and Bristol-Myers Squibb on the Development and Commercialization Rights of BL-B01D1" (Announcement No.: 2023-057) on the website of the Shanghai Stock Exchange (www.sse.com.cn), "Sichuan Baili Tianheng Pharmaceutical Co., Ltd. Voluntarily Disclosed on the Wholly-owned Subsidiary SystImmune Announcement on the Entry into Force of the BL-B01D1 Development and Commercialization License Agreement with Bristol-Myers Squibb (Announcement No.: 2024-005) and the Announcement of Sichuan Baili Tianheng Pharmaceutical Co., Ltd. on the Receipt of an Upfront Payment of US$800 Million with Bristol-Myers Squibb for the Development and Commercialization License Agreement for BL-B01D1 (Announcement No. 2024-008).
On August 24, 2024, the company disclosed on the website of the Shanghai Stock Exchange (www.sse.com.cn).
The 2024 semi-annual report of Sichuan Baili Tianheng Pharmaceutical Co., Ltd. explains the development of the above-mentioned cooperation, and the relevant explanation is consistent with the previous information disclosure.
9. The use of the raised funds and whether they are compliant
In January 2023, the company's initial public offering raised a total of RMB990,470,000.00
After deducting the issuance expenses of RMB106,072,569.72 (excluding VAT), the net proceeds are
RMB884,397,430.28, all of the above raised funds were fully received on December 30, 2022. up to
As of June 30, 2024, the balance of the company's special account for raising funds was RMB11,692,783.73 in 2024
The cumulative amount and balance of the company's raised funds in the first half of the year are as follows:
Item Amount (RMB)
The total amount of funds raised is 990,470,000.00
Less: Issuance costs (excluding tax) 106,072,569.72
Among them: 4,114,078.66 self-raised funds that have been paid for issuance expenses were replaced by raised funds
Net proceeds amounted to 884,397,430.28
Less: Savings raised to permanently replenish liquidity 95,005,064.09
Less: 23,806,771.11 of the balance unpaid at the time of completion of the antibody drug industrialization construction project
Less: Net liquidity was temporarily replenished by using idle raised funds to temporarily replenish 160,000,000.00
Less: The cumulative amount of funds raised was 599,640,042.79
Among them: the actual amount of funds raised was 505,241,489.34
Among them: 94,398,553.45 self-raised funds were replaced by raised funds in advance of fund-raising projects
Less: Handling fee expense of 32,499.86
Plus: Interest income 5,779,730.81
As of June 30, 2024, the balance of funds raised is 11,692,783.24
As of June 30, 2024, the balance of the special account for raising funds was 11,692,783.73
Difference Note 0.49
Note: The difference is the penny difference of 0.49 yuan arising from the payment of issuance fees
For details, please refer to the "Sichuan Bailitian" disclosed on the website of the Shanghai Stock Exchange on August 24, 2024
Heng Pharmaceutical Co., Ltd. 2024 semi-annual special report on the deposit and use of raised funds.
10. Shareholding, pledge, freezing and reduction of shareholdings, pledges, freezes and holdings of controlling shareholders, actual controllers, directors, supervisors and senior managers
As of June 30, 2024, the controlling shareholder and actual controller of the company is Zhu Yi, who is directly held by Zhu Yi
74.34% of the company's shares.
As of June 30, 2024, the Company's current directors, supervisors, and senior management directly hold the Company
The situation of the shares is as follows:
Name Position in the company Number of shares held (shares) Proportion of shares held in the company (%)
Zhu Yi Chairman and General Manager also serve as Chief Section 298,108,880 74.34
Academicians, core technical personnel
Zhang Suya Director, Executive Deputy General Manager, Finance 9,575,543 2.39
majordomo
Kang Jian Director and Deputy General Manager 249,030 0.06
Insight Director, Core Technical Personnel - -
Zhu Hai Director, Core Technical Personnel - -
DAVID
GUOWEI Director - -
WANG
Li Mingyuan Independent Director - -
Xiong Yu Independent Director - -
Yang Min Independent Director - -
Liu Liang Employee Representative Supervisor 31,129 0.01
Wang Jie, Chairman of the Board of Supervisors - -
Fu Ting Supervisor - -
Chen Yingge Secretary of the Board of Directors - -
Mr. Zhu Xi resigned as a director and deputy general manager of the Company on January 30, 2024 for personal reasons;
On February 19, 2024, the general meeting of shareholders of the Company approved Mr. Zhu Hai, a candidate for the Board of Directors, as a director of the Company.
During the reporting period, Ms. Zhang Suya applied for resignation as the secretary of the board of directors of the company due to work adjustment, and after the resignation of the secretary of the board of directors, Ms. Zhang Suya will continue to serve as the director, executive deputy general manager and chief financial officer of the company
Business; In order to ensure the standardized operation of the company, the board of directors of the company approved the appointment of Ms. Chen Yingge on June 21, 2024
As the secretary of the board of directors of the company.
As of June 30, 2024, the company's current controlling shareholders, actual controllers, directors, supervisors and senior executives
There is no pledge, freezing or reduction of the company's shares held by senior management personnel.
11. Other matters on which the Shanghai Stock Exchange or the sponsor institution deems it necessary to express its opinions
Not.
(No text below)
Ticker Name
Percentage Change
Inclusion Date