Securities Star News, May 9, 2024 Baili Tianheng (688506) announced that the company will accept institutional research on May 7, 2024, yongying Fund, Minsheng Jiayin Fund, Southern Fund, Huaqiang Dingxin Investment, Shanghai Qingfeng Asset Management Center (General Partnership), Sino-Dutch Life Insurance, Shanghai Harmony Exchange, Agricultural Bank of China Huili, Shanghai Ruiyang Investment, Shanghai Haichen Investment, Hongyi Yuanyuan Fund, Shanghai Gaoyi Asset, Huaxia Future Capital, HSBC Global Asset Management (Hong Kong) Limited, Shenzhen Zhengdetai, Rongtong Fund, Beijing Shennong Yinong Investment, Shanghai Fund shanghai Shuipu, Wells Fargo Fund, POINT72 ASSOCIATES, LLC, Zhuhai Yingmi Fund, Cinda Australia Bank Fund, Zhongrong Huixin Investment, Happy Life Insurance, Shenzhen Shangcheng Assets, Shanghai Shicheng Investment, Shenzhen Danen Pioneer Investment, Huatai Berry Fund, Pinpoint, Yangtze River Endowment Insurance, Guohua Life Insurance, HCHP Management Limited, Industrial Securities, Shen Wanhongyuan, Neuberger Road Bomai, Fangwu Fund, Hongde Fund, Jinxin Fund, Shanghai Yaozhi Asset Management Center (Limited Partnership) tongyuan Investment Development, Hua 'an Fund, Shanghai Mengyang Investment, Everbright Prudential Fund, Xingyin Fund, Xinnuojiayu Investment, Dacheng Fund, Wanhe Securities, Hangzhou Ganlu Investment Management, Xingyin Financial Management, Xiangchu Assets, Shenzhen Yitong Investment, Jianxin Pension, Beijing Fengrui Private Equity Fund, Shanghai Tianyi Investment, Hainan Fruit Private Equity Fund, Haitong Securities, Manulife, Shanghai Renhao Investment Management Center (Limited Partnership), Guangfa Fund, shanghai Heteng Asset Management, Huafu Fund, Industrial Fund, Shenzhen Zhanbo Investment Management, China Post Securities, Qingrong Asset, Guohua Xingyi Asset, Zheshang Fund, Nomura Securities, Hunan Pharmaceutical Development Fund, CICC, Southwest Securities, Biyun Yinxia Investment Management Consulting, Fulton Investment Management, Beijing Heju Investment, VIVO CAPITAL, LLC, Tianyi Investment, Shenzhen Qianhai Yunxi Fund, Shanghai Life Insurance, Golden Eagle Fund, Shanghai Jingxi Investment, Sunshine Asset Management, AIA, Tianchong Capital, Penghua Fund, Harvest Fund, OrbiMed, Guohai Franklin Fund, Property Zhongda Group Investment, Monita, Xuanjia Investment, Hangzhou Xiaoshan Zequan Investment Management, Industrial Bank, HSBC, Citigroup, Senjin Investment, Shanghai Xinyuan Private Equity Fund, China Fund, Tiger investment, Ping An Assets, Guotai Junan, China Post Venture Fund, EXOME Asset, Yinhua Fund, Baoying Fund, Jingshun Great Wall Fund, Guosheng Securities, Huaxi Pharmaceutical, Northeast Securities, Zhongtai Securities, Hunan Yuancheng Private Equity Fund, China Merchants Fund, Yuchen Investment, SDIC UBS, Tairen Capital, Guoxin Securities, Cinda Pharmaceutical, Haoxiang Asset, Haifutong, Qianhai Kaiyuan, Huajin Daofang Securities, Dalian Securities, Dalian Fund, Guohai Pharmaceutical, Pioneer Fund, Tianfeng Securities, Huatai Assets, Debang Pharmaceutical, Guangfa Securities, Guojin Securities, Pacific Securities, Beijing Zhihe Private Equity Fund, CITIC Securities, HSBC Jinxin Fund, Everbright Securities Proprietary, Shen Wanlingxin, Xunyuan Asset Management, Taiping Pension Insurance, Soochow Securities, Danshui Spring, Bank of China International, Qifeng Capital, Anxin Securities, Shenzhen China Europe Ruibo, Shanghai Hedao Asset Management, Zhejiang Securities financial Management, Elephant Asset Management, Nomura Orient International Securities, Shagang Group Investment Holdings, Morgan Asset Management, Artisan Partners Hong Kong Limited, China Alpha Fund, Shenzhen Zhicheng Haiwei Asset Management, Boyu Capital, Longhang Asset, Tongtai Fund, Hangzhou Huisheng Investment Management, Ningbo Langshi Investment, CITIC Securities Asset Management Department, Trivest Heqi Investment, Orient Securities, Shanghai Fusheng Jiu Asset Management, Noan Fund, Huabao Fund, Shanghai Peng asset Management, Hangzhou Zhaoshi Investment Management, Jiutai Fund, Galaxy Fund, Beijing Sequoia Kunde Investment Management, Taikang Asset, Shenzhen Zhengyuan Investment, AVIC Fund, China Canada Fund, Oriental Alpha Fund, Shenzhen Yihu Investment, Shenzhen Minsen Investment, Shanghai Cactus Asset, Jiangsu Ruihua Investment, Toroa Management (HK) Limited, Shenzhen Red Chip Investment, Guangdong Tianchen Yuanxin Private Equity Fund, Xinhua Asset, Huaxia Fund, Zhengxin Valley, ping An Securities, Taixin Fund, Springhill Qifeng Capital, Soochow Fund, Xiamen Zhonglue Investment, Ningbo Shengshi Confidant Investment Management Center (Limited Partnership), Zhongtian Guofu Securities (Self-operated), Hangzhou Youyi Investment, Anlian Huantong Overseas Investment Fund, Xide Boyuan Capital, China Re Assets, Hua Fu Securities Asset Management, Beijing Jinbairong Investment Management, Taikang Asset Taikang Investment, Wudi Investment, Xinghe Fund, JPMorgan, China assets, Huachuang Securities, Ping An Fund, Peter Mingqi Fund, China Shipping Fund, Shanghai Broadway Investment, Shenzhen Rongshu Investment, PICC Assets, Dunhe Assets, Societe Generale Global Fund, Bosera Fund, PLEAID, CITIC Construction Investment, Huitianfu participated.

The details are as follows:

question: please BL-B01D1(EGFR × HER3-ADC) whether in the field of non-small cell lung cancer treatment, will PD-(L)1 be combined to carry out first-line or even neoadjuvant phase III? Will wild-type NSCLC distinguish the degree of biomarker expression?

A: according to the announcement issued by the company, the phase II clinical study of BL-B01D1 combined with PD-1 monoclonal antibody has obtained the notice of approval of drug clinical trial in eight indications, among which the phase II clinical study of non-small cell lung cancer in the first line has been started. Subsequently, the company will design a phase III registration study based on the clinical efficacy performance and safety data seen in phase II. The company will consider the combination of clinical research in the future to advance to the more front-line such as the new auxiliary treatment stage, the actual drug research and development progress please investors to the company's announcement at that time.

In patients with wild-type NSCLC, according to the data accumulated by the company in clinical studies, there is no difference in efficacy due to the different expression levels of EGFR, HER3 and PD-L1. Overseas, the current first-line PD-1 monoclonal antibody combined with standard chemotherapy is also used in all patients with PD-L1 levels of expression. Therefore, the company's clinical protocol design plan directly controls the PD-1 PBC. However, the clinical protocol design will be communicated with FD and CDE in advance before the actual start of the registration study.

Q: What are the company's future development ideas for new ADC drugs?

A: Generally speaking, the key to the design of DC drugs lies in antibody parts, toxins, coupling and release. In the process of accumulation and optimization of the technology platform over the past years, the company has already possessed leading coupling technology and release technology, so these two are not the focus of further optimization at present. The company will focus on the iteration of new toxins and the exploration of new targets, which is expected to be the focus of early development of the company's new DC pipeline drugs in the future.

question: at present, the company has launched a number of three-phase registration studies on its core products. how to make good use of resources to balance the priority of the indication layout, including how to allocate resources and ensure the subsequent operation efficiency?

a: at present, the company has launched a total of 8 phase III registered clinical trials for its dual antibodies and DC products (BL-B01D1, SI-B001 and BL-M07D1). it is expected that more new phase III clinical trials will be launched in the second half of this year according to the progress of the project. In addition, a number of Phase II clinical trials for first-line patients with different advanced solid tumors BL-B01D1 in the combined PD-1 of monoclonal antibodies have been launched, and BL-B01D1 overseas dose-confirmed clinical studies are being conducted to enroll patients. The above clinical studies are all focused clinical research and development projects. In terms of the company's cash reserves, in the first quarter of 2024, the company has received a down payment of US $0.8 billion based on the international cooperation with BMS. The company's current account has abundant cash to support the rapid progress of the above-mentioned clinical research. In terms of human resources investment, the Phase III registered clinical studies conducted by the company in China are rapidly promoted by the self-built clinical research team, which is relatively efficient and professional in terms of operational efficiency and execution, and we will also consider establishing strategic partnerships with external CRO companies. In the follow-up overseas new clinical development of BL-B01D1, based on the relevant cooperation agreement, the company and BMS will jointly promote its follow-up overseas clinical research in the form of cooperative development and commercialization.

Q: Could you please introduce the CD33 ADC product independently developed by the company and the difference between the CD33 ADC product and the target drug of Pfizer?

A: Pfizer's listed drug Mylotarg (gemtuzumab ozogamicin) with the same target has strong hepatotoxicity. After delisting, it was re-listed through the adjustment of drug administration mode. Although hepatotoxicity has been alleviated, safety problems still exist. Therefore, after re-marketing, it is mainly used for induction therapy for one to two weeks in clinical practice, and other chemotherapeutic drugs are used for consolidation therapy and maintenance therapy, which greatly limits its clinical and market value. ML (acute myeloid leukemia) has a rapid onset and progression, and requires powerful drugs to control its rapid progression. The DR value of CD33 DC of the company is 10, which is more effective. In the current phase I clinical climbing study, the recent dose group shows strong effectiveness signal. At the same time, due to low liver toxicity, it can cover induction therapy and maintenance therapy, and can be used for a long time, which has extremely high clinical and market value, based on the current data, it has the potential to become a Best-in-class drug. From the perspective of future market space and commercial competition, there is currently no good clinical data for other CD33 DC drugs in the clinical research phase to compete with the company's DC, and there is a large number of unmet clinical needs in this area. As the product is still in the early stage of clinical research and development, it has a long cycle and many links from early research and clinical trial approval to production, and is easily affected by a series of uncertain factors. The company will perform continuous information disclosure obligations on the follow-up progress of the project in strict accordance with relevant regulations. Investors are requested to make cautious decisions and pay attention to preventing investment risks.

Q: What are the advantages of the company's multispecific antibody technology platform?

A: The four-specific GNC antibody molecule is an innovative biological drug based on a brand-new mechanism developed by the company's independently developed GNC molecular structure platform with completely independent intellectual property rights and the whole chain integrated multi-specific antibody drug research and development core technology platform. GNC four-specific antibody molecules have obvious differences in pharmacological activity, expression, transformability, technical barriers, etc., and the company expects to achieve breakthrough efficacy in solid tumors.

On the platform, the company expects to have a new project application IND into clinical research this year, and the indication plan will focus on solid tumors. In addition, the company has the ability to systematically address the steric hindrance problems that are prone to multi-resistant products.

Q: What is the company's strategy for selecting targets and antibody sequences when developing ADC products? What are the advantages of the company's ADC products?

A: From the selection of targets, the company will not only select excellent targets that have been accumulated and verified by data, but also vigorously develop new targets. In the screening of DC antibodies, the company will compare its own antibodies with those of similar competitors on its own platform to select the most competitive DC antibodies. In addition, in terms of differentiation advantages, the company's DC platform has been designed differently in both linker and payload, and is developing various types of payload and matching linker. The efficacy and safety of new projects ultimately need to be verified in clinical studies.

Baili Tianheng (688506) Main business: R & D, production and marketing of drugs.

Baili Tianheng's quarterly report in 2024 showed that the company's main revenue was 5.462 billion yuan, up 4325.45 percent from the same period last year. Net profit attributable to the parent was 5.005 billion yuan, up 3100.16 percent from the same period last year. Deduction of non-net profit was 5.005 billion yuan, up 3082.7 percent from the same period last year. Debt ratio 24.97, financial expenses -9.2589 million yuan, gross profit margin 98.92.

the stock has been rated by four institutions in the last 90 days, with three buying ratings and one overweight rating; the average institutional target price in the past 90 days is 183.03.

The following is detailed earnings forecast information:

The margin trading data shows that the net inflow of financing of the stock has 29.6932 million in the past three months, and the financing balance has increased; the net inflow of securities has 24.4284 million, and the balance of securities has increased.

the above content is compiled by the securities star according to the public information and generated by the algorithm (no 310104345710301240019 of the net letter calculation), which has nothing to do with the position of this site. if there is any problem with the data, please contact us. This article is a data compilation, does not constitute any investment advice for you, investment is risky, please be cautious in your decision-making.

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