Review of new drug market this week: from April 18, 2022 to April 22, 2022, the top two enterprises in the new drug sector: heplatinum Pharmaceutical (17.0%) and Dongyao Pharmaceutical (3.2%). The top 5 enterprises with decline: Deqi Pharmaceutical (- 19.2%), Hualing Pharmaceutical (- 16.8%), tengshengbo Pharmaceutical (- 15.5%), Yunding Xinyao (- 15.2%), and pioneering Pharmaceutical (- 12.7%).
Key analysis of the new drug industry this week: on April 22, Jiangsu Hengrui Medicine Co.Ltd(600276) released the 2021 annual report, which announced the latest R & D pipeline, and its innovative drug cluster has a considerable scale. At present, Jiangsu Hengrui Medicine Co.Ltd(600276) has 10 innovative drugs approved for marketing, 65 innovative drugs in clinical development stage (15 in phase 3 clinical stage, including 4 in NDA stage), and a total of 75 innovative drugs; Overseas, a total of 17 innovative drugs have been deployed in overseas clinical trials, and a total of 7 clinical trials have entered phase 3. It covers a wide range of research fields, such as kinase inhibitors, antibody drug conjugates (ADC), tumor immunity, hormone receptor regulation, DNA repair and epigenetics, supportive therapy and so on; It has also been widely distributed in the fields of tumors, autoimmune diseases, pain management, cardiovascular diseases, metabolic diseases, infectious diseases, respiratory diseases, blood diseases, nervous system diseases and other diseases.
Approval & acceptance of new drugs this week: this week, 3 new drugs or indications of new drugs were approved for listing in China, 37 new drugs were approved ind, 22 new drugs ind and 3 new drugs NDA were accepted.
Top 3 of China's new drug industry this week focuses on:
(1) on April 19, the Chinese biopharmaceutical anti-tumor drug arotinib hydrochloride capsule (fukewei) has obtained the drug registration certificate issued by nmpa. The indication is locally advanced or metastatic differentiated thyroid cancer (rairdtc) resistant to inoperable iodine therapy.
(2) on April 19, baizean (tirelizumab injection), an anti-PD-1 antibody drug of Baiji Shenzhou, was approved by nmpa to treat patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who had previously received first-line standard chemotherapy.
(3) on April 20, the cisplatin micelle injection independently developed by the stone pharmaceutical group with the polymer block copolymer as the carrier has been approved by nmpa and can carry out clinical trials in China. To achieve efficient loading of cisplatin, reduce toxic and side effects and target the tumor area is conducive to improve the treatment index of solid tumors.
Top 3 of overseas new drug industry this week focuses on:
(1) on April 18, Pfizer tofatib citrate was approved by the State Drug Administration of China to be used in adult patients with active ankylosing spondylitis (as) with insufficient efficacy or intolerance of one or more TNF blockers.
(2) on April 19, the marketing license of sanofidabitol in the EU was expanded to approve its additional maintenance treatment scheme for patients with poorly controlled type 2 inflammatory severe asthma, becoming the only biological agent approved by the EU for type 2 inflammatory severe asthma.
(3) on April 18, ebervi and genmab jointly announced that epcoritamab, a bispecific antibody under development targeting CD3 and CD20, obtained positive top-line results in the cohort of patients with recurrent / refractory large B-cell lymphoma (lbcl) in the phase 1 / 2 clinical trial.
Risk warning: the risk that the progress of clinical trials is less than expected, the risk that the results of clinical trials are less than expected, and the risk of changes in medical policies.
