Weekly report of innovative drugs in the third week of March 2022 (attached special topic – PI3K) δ Target R & D progress)

Stock and Hong Kong stock innovative medicine sector trend this week

In the third week of March 2022, a total of 31 stocks in the innovative drug sector in mainland and Hong Kong rose, 20 stocks fell and one stock was flat. Among them, the top three gainers are Geli pharmaceutical-b (+ 52.91%), Hualing pharmaceutical-b (+ 19.4%) and Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) (+ 17.95%). The top three declines were Chuangsheng group-B (- 10.38%), Hunan Nucien Pharmaceutical Co.Ltd(688189) (- 7.79%) and gakos-b (- 4.38%). This week, the A-share innovative medicine sector rose 1.38%, outperforming the Shanghai and Shenzhen 300 index by 0.94pp, and biomedicine rose 4.82%. In the past six months, A-share innovative drugs have fallen by 13.16%, underperforming the Shanghai and Shenzhen 300 index by 11.52pp, and biomedicine has fallen by 22.7%. This week, the innovative drug sector of Hong Kong stocks rose 4.72%, outperforming the Hang Seng Index by 4.18pp, and Hang Seng healthcare rose 3.49%. Over the past six months, innovative drugs in Hong Kong stocks have fallen by 17.6%, underperforming the Hang Seng Index by 12.08pp, and Hang Seng health care has fallen by 34.23%.

Progress of key innovative drugs in China

In March, a total of six new drugs were approved for marketing in China. This week, two drugs were approved for listing in China, and two innovative drugs were approved for new indications. Nmpa approved the use of dunxibu capsule of stone Pharmaceutical Group for the treatment of recurrent or refractory follicular lymphoma (FL) after at least two previous systematic treatments. Nmpa can be used in the treatment of advanced esophageal cancer and gastric metastasis. Roche’s atilizumab injection has been approved as a new indication for adjuvant treatment of stage ii-iiia [1] non-small cell lung cancer patients with PD-L1 staining of ≥ 1% tumor cells (TC), surgical resection and platinum based chemotherapy Betta Pharmaceuticals Co.Ltd(300558) of ensatinib hydrochloride capsule has been approved as a new indication for the treatment of patients with anaplastic lymphoma kinase (ALK) – positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Progress of overseas key innovative drugs

In March, no new drug was approved by FDA. No new drugs have been approved this week.

This week’s small topic – PI3K δ Progress in target research and development

Global PI3K under research δ There are 65 inhibitors in total, including 4 approved for listing, 2 applied for listing, 2 in phase III, 1 in phase II / III, 9 in phase II, 4 in phase I / II and 8 in phase I. There are 8 projects under research in China, including 1 approved for listing (stone Pharmaceutical Group), 1 applied for listing (Yingli pharmaceutical, Jiangsu Hengrui Medicine Co.Ltd(600276) ), 1 phase III clinical (Incyte, Xinda Biology), 3 phase II clinical and 2 phase I / II clinical. In these PI3K δ All items are monoclonal antibody items, without bispecific antibody or multispecific antibody items.

Progress of global key innovative drug transactions this week

There were seven key transactions in the world this week, and two of them disclosed the amount, involving companies including Redhill biopharma and kukbo, calliditas therapeutics and Yunding Xinyao.

Risk warning: drug price reduction risk; The implementation progress of medical reform policy is lower than the expected risk; Risk of R & D failure.

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