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Sichuan Baili Tianheng Pharmaceutical Co., Ltd
2025 action plan of "improving quality, efficiency and return".
Sichuan Baili Tianheng Pharmaceutical Co., Ltd. (hereinafter referred to as "the company") always attaches importance to the interests of investors and firmly establishes the concept of investor-oriented. In order to promote the improvement of the quality of business development, investment value and sustainable development, and actively maintain market stability, the "2024 Action Plan for Improving Quality and Efficiency and Emphasizing Returns" has been formulated, and the relevant implementation and effectiveness of the action plan have been summarized, and the "2025 Action Plan for Improving Quality and Efficiency and Emphasizing Returns" has been formulated, the details are as follows:
1. Focus on R&D in the main business areas, continue to enhance the company's competitiveness, and achieve a global layout
1. Continuously enrich the R&D pipeline through a global innovative R&D platform
The company has built a pipeline system of innovative drugs with rich types, echelon layout and global competitiveness, and has successfully advanced a number of innovative drugs under development to the clinical trial stage on a global scale. The company focuses on the field of oncology therapy and has built a world-leading: (1) innovative ADC drug discovery platform (HIRE-
ADC platform), successfully developed 8 innovative ADCs that have entered the clinical stage, including BL-B01D1
drugs and a series of innovative preclinical ADC drugs; (2) Innovative multi-specific antibody R&D platform (GNC
platform), which has successfully developed 4 innovative GNC drugs, including GNC-077, that have entered the clinical stage
and a series of innovative preclinical GNC drugs; (3) Specificity Enhancement Bispecific Antibody Platform (SEBA
Taiwan), successfully developed SI-B001 and SI-B003, two innovative bispecific antibody drugs and lines that have entered the clinical stage
Listed as preclinical innovative bispecific antibody drugs; and (4) the innovative ARC (Nuclear Pharmaceutical) R&D Platform (HIRE-ARC Platform). For details of the aforementioned platforms, pipeline progress and related drugs, please refer to the Company's 2024 Annual Report.
In 2024, the main progress of the company's innovative drug research and development is as follows:
In March 2024, BL-M05D1 received approval for a Phase I clinical trial for the treatment of locally advanced solid tumors
Book.
April 2024, (i) "Chemotherapy ± BL-M07D1+PD-1/PD-L1 monoclonal antibodies" and "BL-M07D1+."
Pertuzumab ±chemotherapy" received approval notice for phase II clinical trial; (ii) BL-B01D1 in recurrent or metastatic esophageal squamous cell carcinoma phase III clinical trial to complete the enrollment of the first subject; (iii) BL-B01D1 for the treatment of patients with locally advanced or metastatic nasopharyngeal carcinoma in the end-line line has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration; (iv) "BL-B01D1+PD-1 monoclonal antibody ±chemotherapy" for the treatment of locally advanced or metastatic non-small cell lung cancer received a phase II clinical trial approval notice.
In May 2024, (i) "BL-B01D1+PD-1 monoclonal antibody ±chemotherapy" was obtained for the treatment of multiple advanced solid tumors
7 Phase II clinical trial approval notices; (ii) BL-B16D1 in the treatment of advanced solid tumors received a phase I clinical trial
Approval Notice; (iii) BL-B01D1 for locally advanced, recurrent or metastatic HR+HER2- breast cancer phase III clinical trial completed the enrollment of the first subject; (iv) BL-M07D1 for the first patient enrolled in the phase III clinical trial of locally advanced or metastatic HER2-positive breast cancer; (v) BL-B01D1 for EGFR-
A phase III clinical trial in locally advanced or metastatic non-small cell lung cancer with EGFR-sensitive mutations that have failed TKI therapy
The first subject was enrolled; (vi) BL-B01D1 in the Phase III clinical trial of locally advanced or metastatic EGFR wild-type non-small cell lung cancer completed the enrollment of the first subject.
In June 2024, BL-M17D1 received approval for Phase I clinical trial for the treatment of advanced solid tumors;
(ii) The Phase I clinical trial application for BL-M05D1 for the treatment of locally advanced solid tumors was cleared by the FDA.
In July 2024, (i)BL-B01D1 for phase III clinical trial in locally advanced or metastatic triple-negative breast cancer
The first subject was enrolled in the trial; (ii) The results of the Phase I clinical study of BL-B01D1 are presented in The Lancet Oncology
The Lancet Oncology; (iii) BL-M14D1 was granted a Phase I clinical trial for the treatment of advanced solid tumors
Notice of trial approval.
In August 2024, the Phase III clinical trial of BL-B01D1 in recurrent small cell lung cancer completed the first patient
Subjects are enrolled;
In September 2024, (i) the GNC-077 multi-specific antibody injection program for the treatment of advanced solid tumors obtained I
Phase II clinical trial approval notice; (ii) The Phase 1/2a clinical trial application for BL-B01D1 combination drug program for the treatment of advanced solid tumors was approved by the FDA.
In October 2024, (i) BL-B01D1 was used for EGFR-sensitive mutations and EGFR wild-type non-small
2 indications for lung cancer patients were included in the Breakthrough Therapy Designation; (ii) BL-B01D1 is included in the Breakthrough Therapy Designation for patients with recurrent metastatic esophageal squamous cell carcinoma who have failed prior PD-1/PD-L1 monoclonal antibody in combination with platinum-based chemotherapy; (iii) FDA clearance was granted for the Phase I clinical trial application of BL-M11D1 for the treatment of patients with relapsed or refractory acute myeloid leukemia.
In November 2024, a Phase I clinical trial of (i) BL-M17D1 for the treatment of patients with advanced solid tumors was filed
Please obtain FDA clearance; (ii) Notice of approval of clinical trial of BL-M08D1 for the treatment of relapsed or refractory hematologic malignancies and locally advanced or metastatic solid tumors.
In December 2024, the GNC-038 quad-specific antibody injection program for the treatment of systemic lupus erythematosus, class
Rheumatoid arthritis obtained the drug clinical trial approval notice.
We will continue to focus on the field of oncology treatment, on the one hand, we will explore the potential of the existing pipeline under development, and explore new indications and combination drug methods. On the other hand, the company will further integrate global resources, increase R&D investment, use the global innovative R&D platform, continue to expand new pipelines under development, and continue to launch internationally competitive blockbuster products to provide patients with more and better treatment options.
2. Based on global competitiveness, we are committed to the research and development of innovative biologics in the world
Globalization is the direction of the company's development, and it is also an important support for the company's future leapfrog development. Company to:
$800 million down payment with a potential total value of up to $8.4 billion co-developed with BMS
The cooperation with commercialization has laid the foundation for the company's globalization and the development of other pipeline products. Currently, BL-B01D1 is in 2 U.S. clinical trials, and follow-up registrational clinical studies in the U.S. will continue. At the same time, the company is also actively advancing Phase I clinical trials in the United States for the treatment of solid tumors with BL-M07D1, BL-M17D1 for the treatment of solid tumors, BL-M05D1 for the treatment of solid tumors, and BL-M11D1 for the treatment of relapsed/refractory AML. In addition, the company will steadily advance the global multi-regional and multi-center clinical studies of the current pipeline under development. By conducting research in patients from different regions, different races, and different disease backgrounds, more extensive and accurate research data can be obtained, which paves the way for the drug to be marketed in multiple countries or regions.
3. Strengthen the construction of talent echelon and empower innovation and global development
Talent is the key element to enhance the company's innovation ability and core competitiveness, the company has a global R&D layout, and has R&D centers in China and the United States. The company's R&D teams in China and the United States have been cultivated in-house
There are also excellent scientists who have grown up, and there are also excellent professionals who have been introduced from the industry. As of December 31, 2024
The company has a total of 1,112 R&D teams in China and the United States, accounting for 44.11% of the company's total employees, including 70 with doctoral degrees and 195 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. Among them, many of them have well-known research institutes in leading multinational companies and domestic biopharmaceutical companies
Research institutions (e.g., UT MD Anderson Cancer Center and Fred Hutchinson Cancer Research
Center) and the FDA's years of experience leading drug discovery and development programs.
In order to support the company's continuous expansion of R&D pipeline and the need to promote global multi-center clinical research, the company will continue to implement the talent strategy of "combining external introduction and internal training" to ensure the trinity of "talent introduction, talent use and talent retention". The company advocates the work style of "dedication, result-oriented, quick response, and timely problem solving", motivates employees to pursue excellence, and realizes personal career growth and development through continuous learning, which is for the company
2. Accelerate the implementation of fundraising and investment projects and promote the company's business development
The company plans to invest 582.5226 million yuan in the raised funds before the adjustment of the "antibody drug clinical research project", and 40.0489 million yuan of the surplus raised funds after the completion of the "antibody drug industrialization construction project" will be used for the new sub-project of the "antibody drug clinical research project", and the adjusted plan to invest 622.5715 million yuan in raised funds.
As of December 31, 2024, the "Antibody Drug Clinical Research Project" has invested in raising funds of 52,505.90
10,000 yuan, and the proportion of raised funds has exceeded 84%.
In 2025, the company will continue to promote the clinical research of ADC drugs, bispecific antibody drugs and multi-specific antibody drugs in the sub-project "R&D Project of Innovative Antibody Drugs in the Field of Tumor Treatment" of the project, accelerate the enrollment progress of various clinical studies, strive to complete the clinical research of drugs as soon as possible and obtain the marketing approval of drugs, and provide patients with new treatment options.
3. Strengthen the foundation and enhance corporate governance capabilities
In 2024, the company will comply with the "Regulatory Guidelines for Listed Companies No. 3 - Cash Dividends of Listed Companies".
The relevant provisions have improved the profit distribution system in the Articles of Association, and clarified the decision-making mechanism of the company's profit distribution and the adjustment principle of the profit distribution policy. In addition, according to the actual needs of the company's operation management and governance structure, the composition clauses of the board of directors have been improved, and the rules and regulations such as the Rules of Procedure of the General Meeting of Shareholders and the Rules of Procedure of the Board of Directors have been revised simultaneously.
In 2025, the Company will continue to improve its corporate governance system and system construction, firstly, fully implement the new Company Law and the latest rules and requirements of the China Securities Regulatory Commission and the Stock Exchange, revise the Articles of Association and supporting governance systems, standardize the operation mechanism of the shareholders' meeting and the board of directors, optimize the functions of the audit committee under the board of directors, strengthen the protection of the rights and interests of small and medium-sized shareholders, and effectively safeguard the legitimate rights and interests of investors. The second is to deepen the construction of the internal control system, improve the closed-loop management of the whole process covering risk identification, assessment, response and monitoring, strengthen the compliance review of key business links, and ensure the legality and efficiency of business activities. The third is to make good use of the dynamic tracking mechanism of legal rules in the capital market, and timely revise the internal system and carry out special training in response to policy changes such as the reform of the registration system and the new regulations on information disclosure, so as to ensure that the company's operation is synchronized with regulatory requirements.
Fourth, strengthen the sharing of interests between management and shareholders, and actively guide the "key minority" to take responsibility
IN 2024, MR. ZHU HAI, MR. DAVIDGUOWEIWANG, AND MR. LIU LIANG, SUPERVISOR, OF THE COMPANY PARTICIPATED IN THE TRAINING OF "INTERPRETATION OF THE REFORM OF THE INDEPENDENT DIRECTOR SYSTEM OF LISTED COMPANIES" AND "STANDARDIZED GOVERNANCE AND BEST PRACTICES OF LISTED COMPANIES" OF THE CHINA SHANGHAI ASSOCIATION; Ms. Zhang Suya and Mr. Kang Jian, directors and senior management, participated in the "Study and Implementation" held by the Sichuan Securities Regulatory Bureau<国务院关于加强监管防范风险推动资本市场高质量发展的若干意见>Spirit and Jurisdiction Supervision Work Meeting"; After the issuance of the new "National Nine Articles", the company issued a letter to all directors, supervisors and senior officers
The managers provided the information of "Interpreting the New "National Nine Articles" Policy, Planning to Improve Quality and Efficiency and Return" for them to learn and understand. Wang Jie, Chairman of the Board of Supervisors, participated in the "Special Training on the Reform of Internal Supervision Institutions of Listed Companies under the Background of the New Company Law" held by the Office of the Financial Commission of the Chengdu Municipal Party Committee; Independent directors Mr. Yang Min, Mr. Yu Xiong, Mr. Li Mingyuan and Mr. Xiao Geng participated in the special training of "Key Points and Suggestions for Independent Directors of Listed Companies to Perform Their Duties against Fraud" of the Shanghai Stock Exchange; Ms. Chen Yingge, secretary of the board of directors, participated in the "2024 7th Follow-up Training for Board Secretaries of Listed Companies" of the Shanghai Stock Exchange.
In 2025, the Company will maintain close communication with the "key minority" such as the controlling shareholder, the actual controller, and the company's directors, supervisors, and senior management, timely communicate the latest regulatory policies and regulations, and improve the "key minority" to perform their duties and awareness of rules. The company will organize the "key minority" to complete the training courses required by regulatory platforms such as the China Securities Regulatory Commission, the Shanghai Stock Exchange and various industry associations to ensure that directors, supervisors and senior managers fully grasp the latest laws and regulations and accurately grasp the guidance of regulatory policies. Through the continuous training mechanism, the company will focus on improving the compliance awareness of the management team, deepen the business philosophy of "improving quality and efficiency, and emphasizing returns", so as to provide a solid guarantee for the sustainable development of the company.
5. Implement the business philosophy of sustainable development and actively practice social responsibility
The company attaches great importance to the important role of environmental, social and governance (ESG) work for enterprises, and released the "2023 Environmental, Social and Governance (ESG) Report" for the first time in 2024, which showcases the company's ESG practices in environmental, social responsibility and corporate governance, and conveys the company's sustainable development concepts and practices to society and all stakeholders.
In 2025, the company will continue to publish the "2024 Environmental, Social and Governance (ESG) Report", and at the same time, deeply integrate the ESG system into all aspects of the company's daily operation and management. By continuously improving the working mechanism and enhancing the professionalism and systematization of ESG practices, we can better respond to investors' concerns and expectations about the company's ESG management and practice information, so as to enhance their confidence in the company's future development and promote the company's sustainable development.
6. Improve the quality of information disclosure and strengthen communication with investors
In 2024, the company's A-shares will be newly included in the CSI 300 Index and the SSE 180 Index. Self-Company Section
Since its listing, the company has conscientiously implemented the relevant requirements of the State Council on improving the quality of listed companies, earnestly fulfilled its social responsibilities, and continuously improved the level of corporate governance, information disclosure quality and standardized operation capabilities. In the 2023-2024 information disclosure evaluation results of listed companies on the Shanghai Stock Exchange released by the Shanghai Stock Exchange, the company was rated as the highest grade A.
The Company held performance briefings with investors through conference calls and webinars to discuss the results, business progress and investor relations for 2023, the first quarter of 2024, the first half of 2024 and the third quarter of 2024
Note the main issues to communicate. In addition, in 2024, the company will actively participate in the collective performance briefing of the biological products industry on the Science and Technology Innovation Board organized by the Shanghai Stock Exchange to effectively interact with investors. The company also interprets the annual report through various forms such as the "Science and Technology Innovation 3 Minutes" video to convey the company's value to investors.
The company has set up a dedicated hotline to answer investors to ensure timely response to investor calls; Through various channels such as public mailboxes, investor research activities and the SSE E interactive platform, we actively communicate and interact with investors to show their public performance
Division good image. In 2024, the company will release 6 copies of the record form of investor relations activities, which will be interacted with through SSE E
The platform answers a total of 32 questions from investors.
In 2025, the Company will continue to adopt a variety of effective investor relations activities, making full use of communication channels such as the investor hotline, investor relations email, investor column on the official website, and "SSE E Interactive" to respond to various questions of investors. At the same time, the company will hold regular performance briefings after the disclosure of regular reports, and it is expected that the number of performance briefings will be held no less than 3 times throughout the year, and invite the company's directors and management to participate in communication, so that investors can have a more comprehensive and in-depth understanding of the company's operating results, financial status and development philosophy. In addition, the company will actively organize and participate in various online and offline research, roadshows, brokerage strategy meetings and other activities, and compile and release the "Investor Relations Activity Record Form" in a timely manner after the reception activities, which is expected to be released no less than 7 times a year.
7. Pay attention to investor returns and share the fruits of development
In order to practice the development concept of "investor-oriented" listed companies, safeguard the interests of all shareholders of the company, and support the company's sustainable and stable development in the future based on confidence in the company's future development prospects, recognition of the company's value and the purpose of earnestly fulfilling social responsibilities, the company disclosed the "Announcement on the Plan for the Actual Controller, Chairman and General Manager to Increase the Company's Shares and the Company's Action Plan for "Improving Quality and Efficiency and Emphasizing Returns" in February 2024. Dr. Zhu Yi, the general manager, has completed the above-mentioned shareholding increase plan.
The company attaches great importance to returning investors in the form of cash dividends, and has formulated the company's "Shareholder Dividend Return Plan for the Next Three Years (2025-2027)". In the future, the company will strictly follow the relevant laws and regulations and the Articles of Association and other provisions, combined with the company's development stage, operating conditions, cash flow and other factors, and actively promote the distribution of profits to shareholders under the condition of meeting the conditions for profit distribution, and increase the implementation of sustainable, stable and scientific returns to investors, so as to effectively protect the legitimate rights and interests of public investors.
8. Other matters
The Company will continue to evaluate the progress of the implementation of the specific measures of the action plan of "Improving Quality and Efficiency, and Valuing Returns", and fulfill its information disclosure obligations in a timely manner. At the same time, the company will continue to focus on its main business and enhance its core competitiveness, profitability and risk management capabilities. Effectively protect the interests of investors through standardized corporate governance and positive investor returns,
Earnestly fulfill the responsibilities and obligations of listed companies, repay the trust of investors, maintain the company's market image, and promote the steady and healthy development of the capital market.
The forward-looking statements of the company's planning and development strategy involved in this report are not fait accompli, and do not constitute the company's substantive commitment to investors, and investors are advised to pay attention to the relevant risks.
Board of Directors of Sichuan Baili Tianheng Pharmaceutical Co., Ltd
March 28, 2025
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