Innovative drug weekly: PD – (L) 1 competition intensifies and subcutaneous injection expands the road

On December 8, the world’s first PD-L1 antibody drug nvida was injected subcutaneously ® The first batch of prescriptions for (nvolimab injection) were delivered to provinces and cities. On the same day, Jiangsu Hengrui Medicine Co.Ltd(600276) subcutaneous injection of PD-1 antibody shr-1901 registered a phase I clinical trial on the website of drug clinical trial registration and information publicity platform. The “advanced war” of PD – (L) 1 products began.

In this week’s weekly report, we introduced in detail the world’s first PD-L1 subcutaneous injection type envolizumab, Jiangsu Hengrui Medicine Co.Ltd(600276) the second PD-1 product, shr-1901, which can be administered by subcutaneous injection, through 13 charts, and comprehensively combed the current competition pattern of PD – (L) 1 inhibitor products in China.

As the first subcutaneous injection type PD-L1 in the world, nvolimab integrates the wisdom of Corning Jerry / thoughtdee / Xiansheng pharmaceutical to achieve a comprehensive breakthrough in the effectiveness, safety, convenience, compliance and universality of nano dosage forms. It has been fully developed in the application of solid tumors such as colorectal cancer, biliary tract cancer, sarcoma, lung cancer, urothelial cancer, liver cancer, endometrial cancer and renal cancer, and has been developed simultaneously in China, the United States and Japan; Its development in viral diseases such as hepatitis B and AIDS is also worth looking forward to.

Jiangsu Hengrui Medicine Co.Ltd(600276) hold the domestic PD-1 heavy variety carrelizumab with the most approved indications and the highest annual sales, and continue to have advantages in dosage form innovation. Shr-1901 is now actively launching the phase I clinical trial involving 180 subjects, which is expected to contribute to the development of PD-1 monoclonal antibody.

At present, 11 PD-1 / PD-L1 antibodies have been approved for marketing in China, including 7 domestic products, 4 imported products, and 1-8 approved indications, which are continuously expanding; In addition, more than 100 PD-1 / PD-L1 products have been registered in clinical trials, with fierce competition. Monoclonal antibody, double antibody, multi antibody and small molecule inhibitor will develop in multimode, and a hundred flowers will bloom in the field of PD – (L) 1 products in the future.

Review on the market of innovative medicine stocks in the pharmaceutical sector: the top 5 gainers and losers in the Shanghai and Shenzhen pharmaceutical innovative medicine sector this week are Shanghai Junshi Biosciences Co.Ltd(688180) – u, Livzon Pharmaceutical Group Inc(000513) , Jiangsu Hengrui Medicine Co.Ltd(600276) , Jiangsu Aidea Pharmaceutical Co.Ltd(688488) , Huadong Medicine Co.Ltd(000963) . The last 5 are Shanghai Allist Pharmaceuticals Co.Ltd(688578) – u, Guangdong Zhongsheng Pharmaceutical Co.Ltd(002317) , Frontier Biotechnologies Inc(688221) – u, Brightgene Bio-Medical Technology Co.Ltd(688166) , Shan Dong Kexing Bioproducts Co.Ltd(688136) .

The top 5 gainers and losers in the pharmaceutical innovation sector of Hong Kong stocks this week were Lizhu pharmaceutical, Hansen pharmaceutical, Xiansheng pharmaceutical, Kingsley biotechnology and Jiahe bio-b. The last five are Baiji Shenzhou, kangnoah-b, Corning Jerry pharmaceutical-b, cornerstone pharmaceutical-b and Peijia medical-b.

IPO this week: Nanmo Biology – Dream building innovation of genetically modified animals

Medium and long term view of the innovative drug industry: in recent years, with the influx of capital stimulated by policies, China has ushered in an innovation wind. China’s innovation market has strong policy attributes. On October 8, 2017, the two offices jointly issued the opinions on deepening the reform of review and approval system and encouraging innovation of drugs and medical devices, which opened the first wave of innovation. With the revision of drug registration management measures, drug negotiation and the introduction of medical insurance dynamic adjustment mechanism, the top-level design of the policy has completely solved the problem of insufficient innovation power in history due to limited R & D resources, non-standard Review & slow progress, low bidding efficiency, high difficulty in admission and difficult connection of medical insurance. 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 gale mouth era. 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.

Risk tips: 1) negative policies continue to exceed expectations; 2) The growth rate of the industry was lower than expected.

 

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