Houlang Forest Research Laboratory |Three-article editing and co-ordination |Xu Jiawei.
"Its burst of value came from the BL-B01D1 transaction with BMS, which could generate up to $8.4 billion in commercial gains. ”
Reading a year in one article is a brief history of the pocket for the year. "The Houlang Forest Research Laboratory has compiled a brief history of Baili Tianheng's annual pocket, which began on January 1, 2023 and ended on March 7, 2024. Shareholders vs. **Baili Tianheng***33664%, 20% of the increase has occurred 6 times, 5% has appeared 32 times。The total share capital is 40.1 billion shares, 22 of which are outstanding56%。The total market value is 43.4 billion yuan. The actual controller, Zhu Yi, holds 7434%。
Baili Tianheng was listed on the Science and Technology Innovation Board of the Shanghai ** Stock Exchange. Issue** 24. per share70 yuan, the issue price-earnings ratio is 2631 times, the opening stock price is 2875 yuan, an increase of 1640% 。Public offering of shares 40.1 billion shares, raising about 142.2 billion yuan. The final strategic placement number is 522690,000 shares, accounting for 1303%。The deviation of the increase for two consecutive trading days has exceeded 30%. For three consecutive trading days, the deviation of the increase has exceeded 30%. 
The number of shareholders was 2,993, a decrease of 18,744 from the listing on January 6, and 25 institutional shareholders held 363%。5 of the top 10 shareholders**: GF Healthcare**A holds 339620,000 shares, Wells Fargo Precision Medicine Flexible Allocation Hybrid A holds 215610,000 shares, E Fund Healthcare Industry Mixed A holds 156030,000 shares, Wells Fargo Healthcare Industry Mixed A holds 137230,000 shares, Xingquan Herun mixed holdings 128510,000 shares. For three consecutive trading days, the deviation of the increase has exceeded 30%. The number of shareholders was 2,838, a decrease of 155 from the first quarter, and a total of 109 institutional shareholders held 2,259090,000 shares accounted for 563%。Jiaxing Haoxiang Dunmin No. 2 quantitative private placement increased its holdings by 212580,000 shares entered the top ten shareholders, and E Fund Healthcare Industry managed by Yang Zhenxiao increased its holdings by 74390,000 shares to 230410,000 shares, Fuguo Precision Medical Flexible Allocation Hybrid A increased by 10140,000 shares to 225750,000 shares. The number of shareholders was 2,221, a decrease of 617 from the first half of the year. Jiaxing Haoxiang Dunmin No. 2 Quantitative Private Placement continued to increase its holdings by 87200,000 shares to 299780,000 shares, GF Healthcare managed by Wu Xingwu **a**40100,000 shares. CEIBS Medical Innovation Investment A, managed by Gülen, became a new top 10 shareholder. For three consecutive trading days, the deviation of the increase has exceeded 30%. 29 institutional shareholders hold 1150170,000 shares. Yang Zhenxiao and Gülen Management** all left the market, and Wu Xingwu's 6 GF** held a total of 517 shares430,000 shares. GF Healthcare **A and GF Pharmaceutical Health Hybrid A hold 358 shares respectively40,000 shares, 83360,000 shares, ranking among the top ten shareholders. Initial public offering of restricted shares 555778.91 million shares were listed and circulated, accounting for 13% of the total share capital8595%。Governance & ControversyThe total amount of funds raised by Baili Tianheng in the initial offering was 9900 million yuan, net funds raised 88.4 billion yuan for the "antibody drug industrialization construction project" and "antibody drug clinical research project". The latter includes: "R&D project of innovative antibody drugs in the field of oncology" and "R&D project of innovative antibody drugs in the field of new crown". Due to the net amount of funds raised 88.4 billion yuan is less than the estimated amount raised by 142.2 billion yuan, the proposed investment in the fund-raising project will be adjusted. 
Lin Xia, supervisor and chairman of the board of supervisors, and Ding Yang, supervisor, both resigned. Lin Xia does not hold Baili Tianheng**, and Ding Yang holds 62,258 shares. Wang Jie and Fu Ting took over as supervisors. R&D funds are inclined to bispecific antibody ADC drugs, and the clinical research of four-specific antibody drugs is funded by fund-raising5$4.4 billion to $3$4.1 billion; The clinical study of bispecific antibody drugs is carried out by 53.6 billion yuan was adjusted to 20.7 billion yuan; The new ADC drug research project is planned to be invested in raising funds34.2 billion yuan. About ADC drugs. BL-B01D1 monotherapy is intended to be advanced to pivotal registration clinical studies in patients with non-small cell lung cancer and nasopharyngeal carcinoma in the later line; Bispecific antibody ADC combined with SI-B003 needs to be studied in phase II clinical studies in a variety of first-line indications for solid tumors; The monoclonal antibody ABD drugs BL-M07D1 and BL-M02D1 are in multiple Phase IA Ib clinical studies. The members of the audit committee of the fourth board of directors were adjusted, and Zhang Suya, director, executive deputy general manager, secretary of the board of directors and chief financial officer, no longer served as a member of the audit committee of the fourth board of directors of the company, and director Zhuozhi took over, and together with Yang Min and Li Mingyuan, he formed the audit committee of the fourth board of directors of the company. Zhu Xi, director and deputy general manager, resigned, and Zhu Hai took over. Zhu Xi holds 90 shares27.37 million shares, Zhu Hai does not hold **, Zhu Hai is the son of Zhu Yi, the actual controller, chairman and general manager. Zhu Hai, the actual controller, plans to increase his shareholding and releases an action plan of "improving quality and efficiency and emphasizing returns". Within 12 months from February 2, 2024, increase holdings by 500-10 million yuan. Action plan of "improving quality and efficiency and emphasizing returns": 1. The actual controller plans to increase the company's shares; 2. Focus on the main business and strengthen the core competitiveness; 3. Accelerate the promotion of fundraising and investment projects; 4. Strengthen communication with investors. Clinical & AcademicThere are 50 key research projects, including 23 innovative biological drug projects and 27 chemical drug projectsBL-B01D1 is the world's exclusive EGFR HER3 bispecific antibody ADC drug, which has entered the phase II clinical study of single agent, and the communication application of BL-B01D1 monotherapy has completed the submission of 3 single-agent double-arm phase III registration clinical trials and 2 single-agent single-arm pivotal registration clinical studies, and is communicating with CDE, and is advancing the phase II clinical study of BL-B01D1 in combination with SI-B003, in combination with chemotherapy drugs, and in combination with osimertinib. BL-M02D1 is an ADC drug targeting TROP2 and BL-M07D1 is an ADC drug targeting HER2, both of which are in phase Ib clinical research and both show strong efficacy signals. BL-M11D1 is an ADC drug targeting CD33 that is in Phase I clinical studies. **The Phase III clinical trial of SI-B001, a bispecific antibody for epithelial tumors such as non-small cell lung cancer, has completed the enrollment of the first patient, and it is the fastest progressing bispecific antibody drug based on EGFR HER3 targets in the world. At present, the four specific antibodies that have entered clinical research in the world are only three types of GNC-038, GNC-039 and GNC-035, which have entered phase IB II, IB and phase IB CLINICAL TRIALS RESPECTIVELY, AND IT IS PLANNED TO EXPLORE A VARIETY OF MALIGNANT TUMORS IN THE FUTURE. 
The world's first phase III clinical study protocol of EGFR HER3 bispecific antibody SI-B001 was held in Guangzhou. Disclosed the main data of BL-B01D1 (EGFR HER3 bispecific antibody ADC) project, ** Locally advanced or metastatic nasopharyngeal carcinoma indication IB expansion phase clinical trial. BL-B01D1 is the world's exclusive bispecific antibody ADC drug targeting EGFR HER3. For BL-B01D1 monotherapy, 5 Phase IA Ib clinical studies have been carried out, covering a total of 16 malignant tumors, and more than 200 subjects involving 12 different tumor types have been enrolled. According to the tumor evaluation data, BL-B01D1 monotherapy has a good safety profile at the recommended dose (RP2D) of phase II for these 12 tumors, and all of them have strong efficacy signals, showing excellent patient benefits, clinical value and market potential, and is likely to become a global blockbuster product in the future. "BL-B01D1 + chemotherapy" and "BL-B01D1+SI-B003 chemotherapy" were approved for phase II clinical trials. Obtained the approval notice for the marketing application of ornidazole API. Seven research results were selected to be presented at the 114th Annual Meeting of the American Association for Cancer Research (AACR) in 2023. BL-M11D1 (CD33-ADC) was approved for Phase I clinical trial in acute myeloid leukemia. BL-B01D1 in combination with osimertinib mesylate was approved for phase II clinical trial. Obtained the approval notice for the marketing application of ribavirin API. Systimmune, a wholly-owned subsidiary, established a Clinical Scientific Advisory Board (CSAC). Obtained the approval notice for the marketing application of sevoflurane API. Obtained the drug registration certificate of sevoflurane for inhalation. Five clinical research results were selected into the 2023 American Society of Clinical Oncology (ASCO), among which BL-B01D1 (EGFR HER3 bispecific antibody ADC) was an oral presentation. Baili Tianhengtong announced the Phase 1 clinical data of BL-B01D1. The data showed that among 34 NSCLC patients with EGFR mutations, the objective extended-release rate (ORR) reached 618%, and the disease control rate (DCR) reached 912%；In 42 patients with EGFR wild-type NSCLC, the ORR was 405% with a DCR of 952%。In a non-head-to-head comparison, DS-1062 was superior to the previous Daiichi Sankyo Trop2-ADC drug DS-1062 in a similar population with an ORR of 26% and a DCR of 70%. NSCLC is a large cancer type, and according to Frost &Sullivan data, the market size of China's NSCLC** drug market will reach 742 in 2023200 million yuan. BL-B01D1 has demonstrated promising anti-tumor activity in patients with non-small cell lung cancer and breast cancer whose disease has progressed after standard**. In terms of the performance of non-small cell lung cancer, BL-B01D1 has the best data in the world. Obtained the drug registration certificate of dexmedetomidine hydrochloride injection (4ml, 10ml). Obtained the drug registration certificate of dexmedetomidine hydrochloride sodium chloride injection (20ml). The amount of investment in the two drugs under development in SI-B001 and BL-B01D1 is 5247390,000 yuan, 9690130,000 yuan, accounting for 15 of the total R&D investment in the current period76% and 2936%, which are the two drugs that Baili Tianheng has invested the most. The clinical trial application of BL-B01D1 (EGFR HER3 bispecific antibody ADC) project for the indication of non-small cell lung cancer was approved by the FDA. The first patient was enrolled in the Phase III clinical trial of SI-B001 (bispecific antibody). Obtained the drug registration certificate of dexmedetomidine hydrochloride sodium chloride injection (50ml, 100ml). Obtained the approval notice for consistency evaluation of fat emulsion injection (250ml: 20%). Two clinical research results were selected for the 2023 European Society of Oncology (ESMO) Congress, of which BL-B01D1 (EGFR HER3 bispecific antibody ADC) was presented orally. The IND application of SI-B001 (EGFR HER3 bispecific antibody) in combination with docetaxel was approved by the FDA. Cooperation and developmentBaili Tianheng propofol emulsion injection is planned to be selected for the ninth batch of national centralized drug procurement, and the winner is **493 yuan box (there is a certain degree of decline compared with the original local average winning bid**), * Guangdong, Sichuan, Hebei, Hunan, Yunnan, Xinjiang (including the Corps), Gansu. 
Systimmune, a subsidiary, entered into an exclusive license and cooperation agreement with Bristol-Myers Squibb ("BMS") for the BL-B01D1 (EGFR HER3 bispecific antibody ADC) project. BMS will make an upfront payment of US$800 million and up to US$500 million in near-term contingent payments to Systimmune; Upon achievement of development, registration and sales milestones, Systimmune will receive up to $7.1 billion in additional payments; The total potential transaction value could be up to $8.4 billion. BL-B01D1 is a potential first-in-class EGFR HER3 bispecific antibody-drug conjugate (ADC). The down payment of this transaction has set a new record for the "down payment" of cross-border BD transactions in recent years, and the potential total transaction value has set a new record for the total price of a global ADC single drug transaction. Under the terms of the agreement, the two companies will work together to advance the development and commercialization of BL-B01D1 in the United States. Systimmune, through its affiliates, will be solely responsible for the development, commercialization and manufacturing of BL-B01D1 in Chinese mainland and in Chinese mainland, as well as for the production of certain pharmaceutical products for use outside Chinese mainland. BMS will be solely responsible for the development and commercialization of BL-B01D1 in the rest of the world. 2024.2.18: The license agreement between the subsidiary Systimmune and Bristol-Myers Squibb for the development and commercialization of BL-B01D1 became effective on February 8, 2024. Performance & ReturnsBaili Tianheng focuses on anti-tumor innovative biological drugs and high-end chemical drugs, and has chemical drug preparations, Chinese patent medicine preparations and innovative biological drugs business segments. Baili Tianheng income 70.3 billion yuan year-on-year -1173%, with a net loss attributable to the parent of 28.2 billion yuan (a loss of 9999 in the same period last year.)130,000 yuan), deducting a non-net loss of 33.7 billion yuan (loss of 15.4 billion yuan), cash flow from operating activities -25.9 billion yuan (-13.5 billion yuan). The revenue of self-chemical drug preparations and Chinese patent medicine preparations was 53.5 billion yuan, 16.7 billion yuan, accounting for 76% of total revenue11% and 2368%。The innovative drug business has no product launches and has not yet generated revenue. R&D investment in 2021 and 2022 will be 27.9 billion yuan, 37.5 billion yuan, accounting for the proportion of revenue. 32%。The profit distribution plan for 2022 is: no cash dividends, no shares, and no capital reserve to increase share capital. 
Baili Tianheng's revenue in the first quarter of 2023 is 12.3 billion yuan, +174%, with a net loss attributable to the parent of 1RMB6.7 billion, net loss of 16.8 billion yuan. H1 income in 2023 is 31.1 billion yuan, +206%, net loss attributable to the parent company of 32.8 billion yuan, net loss of 33.1 billion yuan. R&D investment 33.3 billion yuan, accounting for 107% of revenue, and 649 R&D personnel, accounting for 30% of the total number of employees06%。The R&D team has 46 people with doctoral degrees and 129 people with master's degrees. In addition to Zhu Yi, Zhuozhi, Wanwei Li, Zhu Hai, and Jahan Salar Khalili, the core technical personnel are in addition to Zhu Yi, Zhuozhi, Wanwei Li, Zhu Hai, and Jahan Salar Khalili. He has applied for 426 invention patents in 16 countries or regions around the world (including the European Union), and has obtained a total of 91 domestic and foreign authorized invention patents, including 39 related to generic drugs and 52 related to innovative biological drugs. Revenue for the first three quarters of 2023 was 37.8 billion yuan, a year-on-year increase of -2137%, with a net loss attributable to the parent of 5RMB1.5 billion, net loss of 5400 million yuan. Baili Tianheng's estimated revenue in 2023 is 56.2 billion yuan, a year-on-year increase of -2011%, with a net loss attributable to the parent of 76.4 billion yuan (year-on-year loss expansion), deducting non-net loss of 79.5 billion yuan (year-on-year loss widened). Baili Tianheng attributed the decline in revenue to "due to changes in market demand, national and local centralized procurement, the sales volume and ** of some of the company's products declined, resulting in a decline in revenue." "The decline in net profit is attributed to" first, the company continued to steadily promote the research and development of innovative biological drugs under development, and the research and development expenses increased significantly year-on-year; Second, it is affected by the raw material market, resulting in Chinese herbal medicines and some packaging materialsHonors & ReviewsFor nine consecutive years, it has been selected as one of the top 20 "Best Industrial Enterprises in China's Pharmaceutical R&D Product Line" by China Pharmaceutical Industry Information Center. For eight consecutive years, it has been selected as one of the top 20 "China's innovative pharmaceutical enterprises" by China National Research Institute of Pharmaceutical Industry.