Review of new drug market this week: from December 6, 2021 to December 10, 2021, The top 5 enterprises in the new drug sector: Tianyan Pharmaceutical (+ 21.0%), legendary Biology (+ 13.9%), Shanghai Junshi Biosciences Co.Ltd(688180) (+ 11.8%), Fuhong Hanlin (+ 9.0%), Hansen Pharmaceutical (+ 8.8%); the top 5 enterprises in the new drug sector: Baiji Shenzhou (- 14.0%), Shanghai Allist Pharmaceuticals Co.Ltd(688578) (- 13.6%), Connor (- 11.6%), Corning Jerry (- 8.5%) and cornerstone Pharmaceutical (- 7.6%).
Key analysis of new drug industry this week: this week, Roche disclosed a phase 2 clinical trial of PD-L1 monoclonal antibody atilizhu + tigit monoclonal antibody tiragolumab in the first-line treatment of PD-L1 positive metastatic non-small cell lung cancer (NSCLC) (cityscape study) latest data. Cityscape study showed that among the subgroups with high expression of PD-L1, PD-L1 + tigit group showed excellent efficacy data, with orr of 69%, PD-L1 monotherapy group of 24.1%, MPFs of 16.6 months and 4.1 months, and MOS of NE, respectively (not yet reached) and 12.8 months. In terms of safety, there is little difference between the combined treatment group and the PD-L1 single drug treatment group. Among Chinese enterprises, Baiji Shenzhou is the world leader in the development progress of tigit. At present, two phase 3 clinical trials have been carried out, only lagging behind Roche.
Approval & acceptance of new drugs this week: this week, 4 new drugs or new indications of new drugs were approved for listing in China, 20 new drugs were approved ind, 21 new drugs ind and 1 new drug NDA were accepted.
Top 3 of China’s new drug industry this week focuses on:
(1) On December 8, tengshengbo pharmaceutical announced that the marketing application of covid-19 neutralizing antibody ambacizumab / romistimab combination therapy was approved by nmpa for the treatment of adults and adolescents with light and common types and high risk factors of progression to severe type (12-17 years old, weight ≥ 40kg) patients with covid-19. Among them, the indication for adolescents is conditional approval. This is the first approved covid-19 virus neutralizing antibody combination therapy in China.
(2) On December 10, Baiji Shenzhou announced that the phase 3 clinical trial of PD-1 monoclonal antibody tirelizhu combined with chemotherapy in the first-line treatment of patients with recurrent / metastatic nasopharyngeal carcinoma reached the main end point. Tirelizhu combined with chemotherapy significantly prolonged the PFS of patients compared with placebo combined chemotherapy.
(3) On December 10, Jiangsu Hengrui Medicine Co.Ltd(600276) announced that two new indications of PD-1 monoclonal antibody carrelizhu were approved by nmpa, namely, combined paclitaxel and cisplatin for the first-line treatment of advanced esophageal cancer and combined chemotherapy for the first-line treatment of advanced or metastatic squamous non-small cell lung cancer.
Top 3 of overseas new drug industry this week focuses on:
(1) On December 10, Roche disclosed the latest data of phase 2 clinical trial (cityscape study) of PD-L1 monoclonal antibody atilizhu + tigit monoclonal antibody tiragolumab in the first-line treatment of PD-L1 positive metastatic NSCLC. Cityscape study showed that among the subgroups with high expression of PD-L1, Orr in the combined treatment group was 69%, 24.1% in the PD-L1 monotherapy group, MPFs were 16.6 months and 4.1 months, and MOS were ne (not yet reached) and 12.8 months. In terms of safety, there was little difference between the combined treatment group and the PD-L1 monotherapy group.
(2) On December 8, AstraZeneca announced that FDA approved the application for emergency use authorization of long-acting antibody cocktail therapy evusheld (tixagevimab + cilgavimab) for adults and adolescents with severe immune impairment (12 and above, weight ≥ 40kg), and pre exposure prophylaxis for people who are not suitable for covid-19 vaccine or have insufficient immune response to covid-19 vaccine. This is the first antibody therapy approved by FDA for pre exposure prophylaxis of covid-19.
(3) On December 9, Pfizer and biontech announced that FDA would expand the emergency use scope of its mRNA covid-19 vaccine booster needle to allow people over 16 years old to receive booster needle vaccination after completing two doses of vaccine for at least 6 months. This authorization is based on the positive data of a phase 3 clinical trial: compared with the placebo group, the relative effectiveness of booster needle is 95.6%, which is significant in all age groups Consistent effects are shown.
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.
