Focus of this week: Jiangsu Hengrui Medicine Co.Ltd(600276) clinical R & D pipeline combing and updating
On April 22, 2022, Jiangsu Hengrui Medicine Co.Ltd(600276) issued the 2021 annual report. The company has increased its R & D investment year by year, exceeding 6.2 billion yuan in 2021, accounting for 23.95% of its revenue, a record high. In this annual report, the company disclosed in detail a total of 162 product pipelines currently in the stage of clinical research, including 82 anti-tumor pipelines, 9 metabolic diseases, 7 cardiovascular diseases, 9 pain management, 14 immune inflammation, 6 anti infection, 2 ophthalmology and other 14, and 19 overseas clinical pipelines. Through a comprehensive review of its 162 disclosed clinical pipelines, we expect:
1) approval of new drugs, diabetes treatment drug repaglinide (DPP-IV inhibitor), antineoplastic products SHR3680 (AR antagonist), Lin Puli’s tablets (PI3K δ）、 The anti-tumor product shr-1316 (PD-L1 monoclonal antibody) has submitted the listing application and is expected to be listed in 2022; The antifungal infection product shr8008 (CYP51 enzyme inhibitor) is expected to be on the market in 2023;
2) indications for development, HER1/2/4 combined with trastuzumab and docetaxel for HER+ breast cancer neoadjuvant therapy, and ruimadzolone toluene for bronchoscopy diagnosis and treatment, sedation has been submitted to sNDA, and is expected to be approved in 2022.
3) in terms of new product marketing application, shr8058 (nov03) has reached the end point for dry eye phase III, shr8554 and shr0410 have been used for postoperative analgesia, phase III clinical enrollment has been completed, and it is expected to apply for marketing in 2022;
4) the new indication is submitted. Dahl Sealy (CDK4/6) combined with letrozole / anastrozole as first-line treatment for HR+/HER- breast cancer, PD-1 combined with apatinib (VEGFR inhibitor), first-line therapy for hepatocellular carcinoma, combined chemoradiotherapy for esophageal cancer, and combination of pyrrolidone for adjuvant treatment of HER2+ breast cancer have been completed.
5) in terms of internationalization, the international multicenter phase III study of carrelizumab combined with apatinib in the treatment of advanced liver cancer has started the preparation before the submission of fdabla / NDA in the United States, completed several rounds of communication with FDA, and will submit the listing application in 2022.
Market review of innovative medicine stocks in the pharmaceutical sector:
The top 5 gainers and losers in Shanghai and Shenzhen pharmaceutical innovative drug sector this week are Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) , Livzon Pharmaceutical Group Inc(000513) , Bio-Thera Solutions Ltd(688177) -u, Sichuan Kelun Pharmaceutical Co.Ltd(002422) , Beijing Kawin Technology Share-Holding Co.Ltd(688687) . The last five are Staidson(Beijing) Biopharmaceuticals Co.Ltd(300204) , Shan Dong Kexing Bioproducts Co.Ltd(688136) , Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , Frontier Biotechnologies Inc(688221) – u, Luoxin Pharmaceuticals Group Stock Co.Ltd(002793) .
This week, the top 5 gainers and losers in the pharmaceutical innovative drugs sector of Hong Kong stocks were heplatinum medicine-b, sannuo medicine-b, Shanghai Junshi Biosciences Co.Ltd(688180) , Lizhu medicine and Lepu biology-b. The last five are Deqi pharmaceutical-b, tengshengbo pharmaceutical-b, Yunding xinyao-b, Kaifa pharmaceutical and Sansheng pharmaceutical.
Medium and long term perspective of innovative pharmaceutical industry:
In recent years, with the influx of capital stimulated by policies, China has ushered in a gale of innovation. China’s innovation market has strong policy attributes. On October 8, 2017, the two offices jointly issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of drugs and medical devices, which opened the first wave of innovation. With the revision of the administrative measures for drug registration, drug negotiation and the introduction of the dynamic adjustment mechanism of medical insurance, the top-level design of the policy has completely solved the problem of insufficient innovation power caused by Limited R & D resources, non-standard Review & slow progress, low bidding efficiency, high difficulty in admission and difficult connection of medical insurance in history. Under the stimulation of Programmatic Policies, combined with the promotion of the science and innovation board and the registration system in recent years, the capital of innovative medicine racetrack swarmed, and the financing of innovative medicine enterprises accelerated, which also led China’s innovative medicine investment into the era of gale mouth. Driven by a good policy environment and capital, China’s innovation rise has accelerated. Domestic innovative drugs have entered the harvest period one after another, and more heavy innovative products will be approved and listed in China in the next few years.
What cannot be ignored is that the time window for “general innovation” given by the policy is becoming shorter and shorter, the cost control of medical insurance is becoming stricter, and the track is becoming more and more crowded. We have slowly entered the moment of “selected high-quality innovation”. At present, the homogenization of innovative drug research and development in China is more serious, and the homogenization of targeted drugs is the most serious. The era that innovative drugs are listed as blockbusters is slowly passing, and the time window period of “general innovation” given by the policy is becoming shorter and shorter. We believe that China’s innovative drug market has slowly entered the moment of “selected high-quality innovation” from “general innovation”. In the future, the homogenization competition of McAb popular targets will continue to be intense, and the homogenized products will gradually lose their competitiveness. New technologies, scarce technology platforms, differentiated treatment fields and innovative drug delivery methods may bring a better competitive pattern to enterprises, and companies with technology precipitation are expected to stand out.
Risk tips: 1) negative policies continue to exceed expectations; 2) The growth rate of the industry was lower than expected.
