Pharmaceutical industry weekly: China’s first covid-19 virus neutralizing antibody combination therapy drug approved for listing

From December 6 to December 10, the Shanghai Composite Index rose by 1.63%, the CSI 300 rose by 3.14%, and the Shenwan pharmaceutical and biological sector rose by 1.08%, outperforming the CSI 300 index by 2.06 PCT, ranking 11th among the 28 primary sub industries of Shenwan. Since the beginning of the year, Shenwan pharmaceutical and biological sector has fallen 6.93%, CSI 300 has fallen 3.00%, underperforming the market by 3.93 PCT, ranking 22nd among Shenwan’s 28 primary sub industries. Among the seven sub sectors of medicine, pharmaceutical commerce, medical devices, traditional Chinese medicine, medical services and chemical pharmaceuticals increased by 4.53%, 1.84%, 1.44%, 1.40% and 0.33%, while chemical raw materials and biological products decreased by – 0.01% and – 1.64%. In terms of the rise and fall of individual stocks, hkeholdings, xingkerong pharmaceutical, Baixin international, Yixintang Pharmaceutical Group Co.Ltd(002727) , Guangyuyuan Chinese Herbal Medicine Co.Ltd(600771) , Guilin Sanjin Pharmaceutical Co.Ltd(002275) led the rise this week.

Tengshengbo medicine: China’s first covid-19 virus neutralizing antibody combination therapy drug approved for marketing. Its holding company Tengsheng Huachuang’s covid-19 monoclonal neutralizing antibody ambacizumab / romistimab combination therapy (formerly known as brii-196 / brii-198 combination therapy) has been approved by the China Drug Administration (nmpa) for the treatment of adults and adolescents with light and common types and high risk factors of severe (including hospitalization or death) (12-17 years old, weighing more than 40kg) infected with New Coronavirus (COVID-19), among which adolescents (12-17 years old, weight over 40kg) were eligible for conditional approval.

Jun Shi: about the FDA’s expansion of the authorization scope for the emergency use of etcivir monoclonal antibody and bancivir monoclonal antibody dual antibody therapy to people under the age of 12. The US FDA expands the emergency use authorization scope of double antibody therapy for etesevimab (JS016/LYCoV016) and bamlanivimab (LY-CoV555), adding new mild to moderate New Coronavirus pneumonia “COVID-19” for specific high-risk pediatric population (from birth to under 12 years old). Treatment and post exposure prevention. As of the disclosure date of the announcement, double antibody therapy is the world’s first and only neutralizing antibody therapy authorized for emergency use to cover people under the age of 12, which can provide treatment and prevention of covid-19 for high-risk people of all ages.

Fuhong Hanlin: the phase 3 clinical study of recombinant PD-1 monoclonal antibody combined with chemotherapy in the treatment of es-sclc reached the main end point. The phase 3 hlx10-005-sclc301 study in previously untreated patients with extensive small cell lung cancer (es-sclc) reached the primary end point of overall survival (OS) as evaluated by the independent data monitoring committee (IDMC) in the planned interim analysis.

Hengrui: the new indication of PD-1 inhibitor carrelizumab was approved. It is speculated that the approved indications are: combined paclitaxel and cisplatin for the first-line treatment of advanced esophageal cancer, and combined chemotherapy for the first-line treatment of patients with advanced or metastatic squamous non-small cell lung cancer (NSCLC).

Industry news: 1) Yin min, general manager of AstraZeneca’s China Cancer division, resigned and will join Baiji Shenzhou; 2) The State Food and Drug Administration approved the registration of 187 medical device products in November; 3) The State Food and Drug Administration issued 19 industrial standards for medical devices; 4) The latest research and development progress of Chinese vaccines and drugs related to Omicron.

 

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