Stock code: 688506 Stock abbreviation: Baili Tianheng Announcement No.: 2023-025
Sichuan Baili Tianheng Pharmaceutical Co., Ltd.
Announcement on Receipt of Letter of Inquiry from Shanghai Stock Exchange
the company's board of directors and all directors to ensure that the contents of this announcement does not exist any false records, misleading statements or major omissions, and the authenticity, accuracy and completeness of the contents of the legal responsibility.
Sichuan Baili Tianheng Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") on March 22, 2023
Received the "Inquiry Letter on the Change of Sub-projects of Some Fundraising Projects of Sichuan Baili Tianheng Pharmaceutical Co., Ltd." issued by the Management Department of the Shanghai Stock Exchange Science and Technology Board Company (Shanghai Science and Technology Innovation Letter [2023] No. 0050) (hereinafter referred to as the "Inquiry Letter"), the specific contents are as follows:
"On March 23, 2023, your company disclosed the" Public Statement on the Change of Sub-projects of Some of the Company's Fundraising Projects ".
According to the report, some of the clinical trial sub-projects in one of the fund-raising investment projects, the "antibody drug clinical research project", were changed according to the progress of clinical trials and funding arrangements for innovative drug biologics. After a post-review, in accordance with Rule 14.1.1 of the Rules Governing the Listing of Shares on the Shanghai Stock Exchange, your company is requested to verify and disclose the following matters:
1. your company goes public on January 6, 2023. Within 3 months of listing, the company was listed on January 16
On March 23, it disclosed that the funds to be invested in the fund-raising project were adjusted due to the net amount of funds raised being lower than the expected amount to be raised, and on March 23, it disclosed the change of some of the sub-projects of the fund-raising project. Among them, the amount of funds to be raised for clinical research of tetraspecific antibody drugs (hereinafter referred to as tetraspecific drugs) was first reduced from 544.2108 million yuan to 273.6946 million yuan, and finally to 34.0729 million yuan. The amount of funds to be raised for clinical research of bispecific antibody drugs (hereinafter referred to as dual antibody drugs) was first reduced from 535.8481 million yuan to 286.58 million yuan, and finally adjusted
206.8587 million yuan; At the same time, new ADC drug research projects, to invest in fund-raising 341.591 million
Yuan.
Your company is requested to: 1) supplement and disclose the background, reasons and rationality of the major adjustment in the key research and development direction of the company within 3 months of listing, and whether there have been any major changes in the research and development progress, experimental data and commercialization prospects of the original investment projects; if so, supplement the specific impact of such major changes on the adjustment of investment projects and whether the early risk warning is sufficient. 2) Supplementary disclosure of the company's pre-fund-raising project determination basis, capital arrangement, use plan and feasibility study, as well as the specific circumstances of the implementation and change of the fund-raising project after listing, fully evaluated.
Whether the determination, capital arrangement, investment plan and previous changes of the previous fund-raising project are reasonable and prudent. 3) Supplementary disclosure of the relevant decision-making process for the determination, promotion and change of the above-mentioned fund-raising projects, the main decision makers of the project change, the specific work performed by all directors, supervisors and senior managers of the company on the above matters, whether it conforms to the provisions of the articles of Association and other internal regulations.
2. on dual anti-drug. According to the company's announcement, the proposed investment in clinical research of dual anti-drug funds
The amount was first reduced from 535.8481 million yuan to 286.58 million yuan and finally adjusted to 206.8587 million yuan.
Your company is requested to: 1) additionally disclose the company's specific investment details and investment schedules for each sub-project in terms of dual anti-drugs. 2) Combined with the company's financial situation, funds in hand and the current research and development progress of dual anti-drugs, research and development capital needs, etc., supplementary disclosure of the reduced capital investment can support the company to continue to promote related projects, whether it will have a significant adverse impact on the company's dual anti-drug research and development.
3. on four anti-drugs. The announcement disclosed that the company has made GNC-035, GNC-038 and GNC-039
Phase I clinical studies have been carried out; the results have shown that the above drugs have strong effectiveness signals in blood system tumors, breast cancer and other indications, and have good safety. After comprehensive consideration of the clinical progress of the research pipeline, in order to improve the efficiency of the use of funds raised, the company intends to steadily promote the GNC-038 and GNC-039 in the research project on the basis of the original plan GNC drug project after the expected use of funds to ADC drug clinical trials tilt.
Please your company: 1) combine the company's existing GNC-035, GNC-038 and GNC-039 clinical research
Progress and data, additional disclosure of whether there is less than expected progress in research and development, fully explain the company's substantial reduction in the amount of funds to be invested. 2) Based on the company's operating performance, financial status, and funds in hand in recent years, supplement and disclose the later research and development promotion plan, funding requirements, funding arrangements and feasibility of the above-mentioned four anti-drugs, and fully explain whether the reduced capital investment can support The company continues to promote related projects and whether it will have a significant adverse impact on the company's research and development of related four anti-drugs. 3) Combined with the above-mentioned four anti-drug research and development difficulty, research and development cycle, research and development risk, research and development funding requirements, as well as related research is still in clinical phase I, etc., fully disclose and prompt the above-mentioned company four anti-drug research and development of the adverse factors and risks.
4. on ADC drugs. Announcement disclosure, BL-B01D1 single drug proposed in non-small cell lung cancer, nasopharyngeal
Advancing to key registry clinical studies in patients with post-cancer lines; dual anti-ADC combination SI-B003 required in multiple entities
Phase II clinical studies for first-line tumor indications; monoclonal antibody ABD drug BL-M07D1 and BL-M02D1 are positive.
Multiple Phase Ia/Ib clinical studies are being conducted. Taking into account the efficiency of the use of raised funds, the company intends to invest short-term idle funds in ADC projects that are currently progressing rapidly in clinical practice and are expected to make breakthrough progress in a relatively short period of time.
Your company is requested to: 1) provide additional disclosure of the company's specific investment details and investment schedules for each subdivision of ADC drugs. 2) Supplementary disclosure of whether this increase in the amount of investment in ADC drug projects involves major changes in the arrangement of research and development personnel, will affect the normal progress of the company's other research projects. 3) Combined with the Ia/Ib clinical trial data obtained by the BL-B01D1 single drug, the data comparison with the competing products, the approval of clinical trials, and the specific communication between the company and CDE on the conduct of key registered clinical studies, the reasonableness and feasibility of the company's new BL-B01D1 single-drug clinical research project are disclosed. 4) Combined with BL-M07D1 and BL-M02D1 preclinical trial data, clinical trial progress and data, as well as comparisons with other competing products, the reasonableness and feasibility of the Company's new BL-M07D1 and BL-M02D1 single-drug Phase Ia/Ib clinical research projects are disclosed. 5) Combined with the research and development risk of ADC drugs, research and development cycle, research and development capital requirements and the company's above-mentioned drugs are still in the early clinical situation, fully disclose and prompt the adverse factors and risks faced by this new ADC drug clinical research project. 6) According to the company's disclosed performance report, the company's net profit in 2022 is -286.0672 million yuan and the net assets at the end of the period are 930.1949 million yuan. Please combine the company's performance, financial situation, funds in hand, and R & D personnel arrangement with the continuous decline of operating income and continuous loss in recent years, fully disclose and alert the material adverse impact that may have on the advancement of the Company's other research projects and the Company's ability to continue as a going concern in the event of a failure in the development of the relevant ADC drug, and disclose the specific measures to be taken by the Company to address the relevant losses and safeguard the progress of other research projects.
The independent directors and continuing supervisory bodies of your company are invited to comment on each of the above issues.
Please ask your company's continuous supervision agency to combine the work done in the process of determining, promoting and changing the fund-raising project, and explain whether it has fulfilled the sponsorship duties and continuous supervision obligations for the use and management of raised funds in accordance with relevant regulations.
Your company is requested to disclose this inquiry letter as soon as it receives it and to disclose the reply by March 29, 2023.
capacity."
The company and the continuous supervision agency will actively respond to the issues involved in the "Inquiry Letter" in accordance with the requirements of the "Inquiry Letter" and perform information disclosure obligations in a timely manner. Investors are kindly requested to pay attention to the company's announcement and pay attention to investment risks.
It is hereby announced.
Board of Directors of Sichuan Baili Tianheng Pharmaceutical Co., Ltd.
March 23, 2023
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