Review of new drug market this week: from April 25, 2022 to April 29, 2022, the top 5 enterprises in the new drug sector: Corning Jerry (19.0%), Maibo Pharmaceutical (14.9%), Shanghai Junshi Biosciences Co.Ltd(688180) (14.2%), Genxi biological (10.8%) and gakos (9.5%). The top 5 enterprises with decline: kangnaide (- 24.8%), Yunding Xinyao (- 15.6%), Keji Pharmaceutical (- 13.1%), tengshengbo Pharmaceutical (- 11.5%) and Jiangsu Hengrui Medicine Co.Ltd(600276) (- 10.7%).
Key analysis of the new drug industry this week: this week, Pfizer announced that its covid-19 oral drug paxlovid failed to prevent phase 2 / 3 epic-pep after covid-19 exposure. The results of epic-pep clinical study showed that the risk of covid-19 infection in adults taking paxlovid for 5 and 10 days was reduced by 32% and 37%, respectively, compared with the placebo group.
At present, only three neutralizing antibodies have been approved for covid-19 prophylactic drugs worldwide, of which two have been suspended due to poor efficacy on Omicron. In terms of small molecule oral drugs, in addition to Pfizer paxlovid, mosadon molnupiravir and romarknt-300 (nitazonit sustained release tablets) have carried out phase 3 research on post exposure prevention. At present, there is no research data disclosure. Considering Pfizer’s effectiveness in the high-risk group of patients with mild to moderate diseases (89% reduction in the risk of hospitalization or death compared with placebo), the application of small molecule oral drugs in covid-19 prevention in the future still needs to wait when Pfizer fails to make significant effectiveness in the post exposure prevention study of covid-19.
Approval & acceptance of new drugs this week: this week, 3 new drugs or indications of new drugs were approved for listing in China, 26 new drugs were approved ind, 26 new drugs ind were accepted, and 9 new drugs NDA were accepted.
Top 3 of China’s new drug industry this week focuses on:
(1) on April 27, the global phase 3 clinical trial of Baiji Shenzhou PD-1 monoclonal antibody tirelizumab in the first-line treatment of esophageal squamous cell carcinoma achieved positive results. According to the pre-set interim analysis by the independent data monitoring committee (IDMC), it has reached the main end point of overall survival.
(2) on April 29, the new indication of belintoumab (bispecific CD19 directed cd3t cell adaptor molecule) for injection in Baiji Shenzhou was approved to be listed for the treatment of recurrent or refractory precursor B-cell acute lymphoblastic leukemia in adults and children.
(3) on April 26, Shanghai Allist Pharmaceuticals Co.Ltd(688578) vometinib mesylate tablets were announced by CDE to be included in breakthrough treatment for adult patients with locally advanced or metastatic non-small cell lung cancer with positive EGFR exon 20 insertion mutation and disease progression during or after platinum containing chemotherapy.
Top 3 of overseas new drug industry this week focuses on:
(1) on April 28, Lilly was developing tirzepatide, a dual agonist of Glucose dependent insulinotropic peptide and glucagon like peptide-1 receptor, which had a significant effect on weight loss in the first registered global phase 3 clinical trial for the treatment of obese or overweight groups.
(2) on April 27, Pfizer ALK inhibitor loratinib was approved to be listed in China for the treatment of ALK positive advanced NSCLC. It is the first approved third-generation ALK inhibitor in China. In preclinical studies, it shows strong and selective inhibitory activity and can penetrate the blood-brain barrier.
(3) on April 24, AstraZeneca announced that the market application of CTLA4 monoclonal antibody tremelimumab combined with PD-L1 monoclonal antibody imfinzi for the first-line treatment of unresectable hepatocellular carcinoma was accepted by FDA.
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.
