Review of new drug market this week: from February 7, 2022 to February 11, 2022, the top 5 enterprises in the new drug sector: Genxi Biology (26.9%), Kaifa Pharmaceutical (24.6%), Xiansheng Pharmaceutical (7.6%), Geli Pharmaceutical (6.6%) and Yaoming junuo (5.4%); The top 5 enterprises with decline: oukangweishi (- 12.4%), Yunding Xinyao (- 10.4%), Shanghai Junshi Biosciences Co.Ltd(688180) (- 9.6%), kangnaide (- 9.5%), Yongtai Biology (- 8.6%).
This week, the new drug industry focused on the following analysis: in February 11th, NMPA approved the import registration of Pfizer Inc COVID-19 virus therapeutic drug NAT MATV tablets / Ritonavir Tablets package (Paxlovid) for the treatment of mild to moderate New Coronavirus pneumonia (COVID-19) in adults with severe risk factors, such as advanced age, chronic kidney disease, diabetes mellitus, and so on. Patients with severe high-risk factors such as cardiovascular disease and chronic lung disease. This approval shows that Chinese regulators attach importance to covid-19 oral drugs, and the development of domestic covid-19 oral drugs is expected to accelerate.
In China, the development of small molecule covid-19 drugs is accelerating. Small molecule covid-19 drugs developed by real organisms, Shanghai Junshi Biosciences Co.Ltd(688180) / Wangshan wangshui / Chinese Academy of Sciences, Frontier Biotechnologies Inc(688221) and other enterprises have entered the stage of clinical development, and at least seven small molecule covid-19 drugs are also in the stage of preclinical development.
In addition, on February 7, Shionogi, a Japanese enterprise, released some data of phase 2a of phase 2 / 3 clinical trial of covid-19 oral drug s-217622. Yanye said that the company will seek conditional early approval as soon as possible. The production capacity is expected to reach 1 million doses in March, and plans to achieve a production capacity of more than 10 million doses / year after April. In addition, yanye said that he has found partners around the world to jointly develop s-217622.
The trial in which yanye disclosed data was a randomized, placebo-controlled, double-blind study of Japanese adults. A total of 47 patients with mild and moderate covid-19 were divided into placebo group (17), low-dose group (16) and high-dose group (14).
\u3000\u30001. Antiviral effect:
(1) compared with placebo group, virus titer and RNA were significantly reduced;
(2) compared with placebo group, the positive rate of virus titer decreased by about 60-80% on the 4th day after administration (after the third dose);
(3) compared with placebo group, the median time of virus titer turning negative was shortened by 2 days;
\u3000\u30002. Improvement of clinical symptoms
(1) the overall score of symptoms in the treatment group was improved;
(2) compared with the placebo group (14.3%, 2 / 14), there were no deterioration cases requiring hospitalization or equivalent to hospitalization in the treatment group (0%).
\u3000\u30003. Security
No treatment-related serious adverse events were observed, and no adverse events leading to drug withdrawal were observed.
\u3000\u30004. Mutant coverage
In vitro studies showed that s-217622 was effective against Omicron mutant.
After the outbreak of Omicron, monoclonal antibody therapy developed in many countries has proved ineffective for Omicron, and the production capacity is very limited. The emergence of covid-19 oral drugs is another important milestone in the fight against covid-19 epidemic, which helps isolate people at home to fight the virus, prevent disease progression, and reduce the rate of severe illness and hospitalization. Previously, only paxlovid of Pfizer and molnupiravir of Merck were approved for emergency use in the world, but the production capacity was low. Yanyeyi's covid-19 drug approval will expand more production capacity for anti covid-19 oral drugs. S-217622 is an oral 3CL protease inhibitor, which is the same as Pfizer's paxlovid target. 3CL protease is the key protease for covid-19 virus replication. At present, many pharmaceutical enterprises outside China have laid out this target.
Approval & acceptance of new drugs this week: this week, 11 new drugs or new indications of new drugs were approved for listing in China, 27 new drugs were approved for ind, 46 new drugs for ind and 4 new drugs for NDA.
Top 3 of China's new drug industry this week focuses on:
(1) on February 10, FDA held an ODAC meeting to discuss the need for additional clinical trials of cindilimab for the first-line treatment of non squamous NSCLC in the United States. ODAC voted 14:1 for the need to supplement additional clinical data. Cinda Bio said that FDA has no doubt about the safety and effectiveness of cindilimab. Cinda and Lilly will continue to cooperate with FDA to complete the review of BLA. At the same time, in this application, CITIC Dade has conducted in-depth communication and exchange with FDA, exercised the overseas registration team and provided experience for subsequent overseas development. The subsequent companies will still adhere to the global development of pipelines.
(2) on February 9, yttrium [90Y] microsphere injection (SIR spheres) of Yuanda medicine ®） Approved for marketing to treat patients with inoperable colorectal cancer liver metastases who have failed standard treatment.
(3) on February 9, cornerstone pharmaceutical's selective oral mutant isocitrate dehydrogenase (IDH1) inhibitor avonib tablets were approved for marketing to treat adult recurrent or refractory acute myeloid leukemia (R / RAML) with susceptible IDH1 mutation.
Top 3 of overseas new drug industry this week focuses on:
(1) on February 7, some data results of phase 2a of phase 2 / 3 clinical trial of yanyeyi's anti covid-19 virus drug s-217622 were positive. S-217622 is an oral 3CL protease inhibitor, which can improve 12 covid-19 symptoms on the whole. No deterioration cases requiring hospitalization or similar hospitalization were found in the treatment group.
(2) on January 31, FDA officially approved Moderna covid-19 mRNA vaccine (trade name spikevax) to prevent covid-19 virus infection in people over 18 years old. On December 18, 2020, the vaccine was authorized by the FDA for emergency use (EUA). The drug is the second covid-19 mRNA vaccine officially approved by FDA after Pfizer / biontech's covid-19 mRNA vaccine.
(3) on January 31, Novavax announced to submit its application for emergency use authorization (EUA) of covid-19 recombinant protein vaccine nvx-cov2373 to FDA. The effective rate of nvx-cov2373 was 90.4% in the United States and Mexico, 89.7% in the United Kingdom, 86.3% in mutant b.1.1.7 and 96.3% in non mutant b.1.1.7. The effect was comparable to that of Pfizer / biontech and Moderna mRNA vaccine.
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.
