Viewpoint of biomedical new drug week: the top line data of prochloramide have been released, and clinical data of several covid-19 drugs have been disclosed all over the world

Review of new drug market this week: from April 4, 2022 to April 8, 2022, new drug sector

The top 5 enterprises with growth: Kaifa Pharmaceutical (151.0%), Yunding Xinyao (21.9%), Hebo Pharmaceutical (16.3%), Yaoming junuo (13.9%) and kangnoah (12.2%).

The top 5 enterprises of decline: Tianjing biological (- 19.1%), Shanghai Junshi Biosciences Co.Ltd(688180) (- 8.9%), Betta Pharmaceuticals Co.Ltd(300558) (- 8.3%), Shanghai Allist Pharmaceuticals Co.Ltd(688578) (- 8.1%), Sinocelltech Group Limited(688520) (- 8.0%).

Key analysis of the new drug industry this week: on April 6, Kaifa pharmaceutical announced the key data results of phase 3 global multicenter clinical trial of prochloramide in the treatment of mild and moderate non hospitalized covid-19 patients. Studies have shown that prochloramide can effectively reduce the hospitalization / mortality of mild and moderate covid-19 patients, especially for all patients taking medicine for more than 7 days, and the corresponding protection rate is 100%; In subjects with high risk factors (especially in the middle and high age group), it can significantly reduce hospitalization / mortality; It can significantly and continuously reduce covid-19 virus load and improve covid-19 related symptoms.

At present, a number of covid-19 therapeutic drugs have been approved in the mainstream markets led by the United States and Europe, including small molecule oral drugs, neutralizing antibodies and other different types of therapeutic drugs, which have shown good effectiveness in covid-19 prevention, treatment of mild and moderate patients and treatment of severe patients. In covid-19 prevention: neutralizing antibody combination therapy is used to prevent covid-19, which can reduce the risk of covid-19 by about 70 ~ 80%; The application of small molecule oral drugs in covid-19 prevention is still in the stage of clinical research.

In terms of treatment of mild and moderate diseases: small molecule covid-19 oral drug paxlovid can reduce the risk of hospitalization or death by 89% compared with placebo, molnupiravir can reduce the risk by 30%, and redcivir injection can reduce the risk by 87%; Nt-300 (nitazonit sustained release tablets) has been found in clinical studies on the treatment of patients with mild and moderate diseases to reduce the risk of progression to severe diseases by 85% compared with placebo. In addition, neutralizing antibodies can reduce the risk by 70 ~ 80%.

In terms of severe treatment: for different degrees of hospitalized patients, redcivir, baretinib and tozumab also showed considerable efficacy, which can improve the occupation of medical resources.

Approval & acceptance of new drugs this week: this week, 7 new drugs or indications of new drugs were approved for listing in China, 28 new drugs were approved for ind, 19 new drugs for ind and 4 new drugs for NDA.

Top 3 of China's new drug industry this week focuses on:

(1) on April 4, Shijiazhuang Pharmaceutical Group announced that its independently developed covid-19 mRNA vaccine sys6006 has been approved by nmpa to carry out clinical research.

(2) on April 4, Cansino Biologics Inc(688185) bio announced that its covid-19 mRNA vaccine had obtained nmpa clinical trial approval.

(3) on April 6, Cinda bio dabetan (pemigatinib, English trademark: pemazyre) was approved by nmpa for the treatment of adult patients with advanced, metastatic or unresectable cholangiocarcinoma who had received at least one systematic treatment and had FGFR2 fusion or rearrangement.

The top 3 of overseas new drug industry this week focuses on: (1) on April 8, Johnson & Johnson's jnj-75348780 injection clinical trial applied for nmpa

Approved as the first approved clinical CD3 / CD22 double antibody in China for the treatment of B-cell non-Hodgkin's lymphoma (B cell NHL) and chronic lymphocytic leukemia (CLL).

(2) on April 8, Lilly's donanemab injection clinical trial application was accepted for the treatment of Alzheimer's disease (AD).

(3) on April 7, the listing application of Novartis erenumab injection was accepted to prevent migraine in adults.

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.

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