Morning, here's 21 Health News Daily! Welcome to pay attention to the latest events in the pharmaceutical and health industry with the new health team of 21st Century Business Herald!
First, policy trends
●The State Food and Drug Administration notified 71 batches of unqualified cosmetics
On the 19th, the State Food and Drug Administration issued a notice on 71 batches of unqualified cosmetics. In the 2021 national cosmetics supervision and sampling work, after inspection by Jiangxi Provincial Institute of Drug Inspection and Testing and other units, 71 batches of cosmetics such as BONYHAiR hair dye cream (brown) produced by Guangzhou Bangni Fine Chemical Co., Ltd. were unqualified (see annex).
According to the Regulations on the Supervision and Administration of Cosmetics and the Measures for the Supervision and Administration of the Production and Operation of Cosmetics, the State Food and Drug Administration requires the drug supervision and administration departments of Guangdong and Zhejiang Provinces to file a case against the registrants, recorders and entrusted production enterprises involved in the above 71 batches of unqualified cosmetics in accordance with the law, and order the relevant enterprises to immediately take risk control measures and carry out self-inspection and rectification in accordance with the law; the drug supervision and management departments of various provinces (autonomous regions and municipalities) order the relevant cosmetics operators to immediately stop operating the above cosmetics and investigate their purchase inspection records in accordance with the law. Trace the root causes of illegal products; where illegal conduct is discovered, it shall be seriously investigated and dealt with in accordance with law; and where a crime is suspected, it shall be transferred to the public security organs in accordance with law.
2. Examination and approval of pharmaceutical devices
●Hengrui Pharmaceutical PD-L1 Adebeliumab was declared on the market
On the 19th, the official website of CDE showed that Hengrui Pharmaceutical's PD-L1 monoclonal antibody Adebelimumab listing application was accepted. This is the fifth domestic PD-L1 monoclonal antibody to be declared for listing.
Adebellimumab injection is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui Pharmaceutical, which can block the PD-1/PD-L1 pathway that leads to tumor immune tolerance by specifically binding PD-L1 molecules, and reactivate the anti-tumor activity of the immune system, so as to achieve the purpose of treating tumors. Several clinical studies of Adebellidimumab injection are currently underway to assess its antitumor effect on various types of solid tumors. On October 27 last year, Hengrui announced that the main endpoints of its PD-L1 monoclonal antibody SHR-1316 (Adebellimumab) combined with chemotherapy in the first-line treatment of wide-stage small cell lung cancer (SHR-1316-III-301) met the predetermined efficacy criteria.
●North China Pharmaceutical Class 1 new drug omativirmab is about to be approved
On the 19th, the official website of NMPA showed that the new drug omativirmab of North China Pharmaceutical Class 1 has entered the approval stage and is expected to be approved in the near future for passive immunization of rabies virus exposure patients.
Recombinant human anti-rabies virus monoclonal antibody injection (rhRIG) is an independent innovation project of North China Pharmaceutical and is listed as a major special breed of national "major new drug creation" science and technology.
In April 2020, the clinical results of rhRIG project III showed that rhRIG and human rabies vaccine achieved primary efficacy and secondary efficacy endpoints in post-exposure prevention of people with grade III suspected rabies virus exposure, and the safety was good, reaching the program setting goals. In July 2020, the recombinant human anti-rabies virus monoclonal antibody injection was reported for marketing, and was later included in the priority review by the CDE. At present, there is no recombinant anti-rabies virus monoclonal antibody drug for sale in China, and the only passive immune preparations that can be used for post-exposure prevention of rabies virus in China are anti-rabies serum and immunoglobulin in rabies patients.
3. Capital market
● Baiquan Biotech announced the completion of tens of millions of yuan angel round financing
Recently, Shanghai Baiquan Biotechnology Co., Ltd. announced the completion of a multi-million yuan angel round of financing, this round of financing led by the Shanghai Biomedical Fund, dart accelerator (ATLATL) followed by investment.
Founded in Shanghai in December 2020, based on the unique and profound insights of the founding team in the field of tumor immunity, the company built an integrated platform for the discovery of new targets of tumor immunity - BioTroy Engine, and fully verified the function of new targets that can independently mediate tumor immune escape and the corresponding translational medicine development value through systematic research such as clinical proteomics and receptor omics.
●In 2021, 34 medical and health companies will IPO in Hong Kong
At present, Hong Kong has become the second largest fund-raising center for biotechnology in the world, and it is also the preferred market for many healthcare companies to list. According to industry statistics, a total of 34 "medical and health enterprises" will be listed on the Hong Kong Stock Exchange in 2021, including 20 unprofitable biotechnology companies, 3 Internet medical companies, and 11 other medical and health companies. In addition, among the listed enterprises, there are 65 medical and health companies that have not yet been listed, including 20 unprofitable biotechnology companies, 8 Internet medical companies, and 3 oral medical service companies.
●Shuke toothpaste brand company Vimax plans to go to Hong Kong for IPO
On January 18, the China Securities Regulatory Commission (CSRC) announced the progress of Vimax Industrial (Guangdong) Co., Ltd.'s "Approval of Overseas Initial Public Offering of Shares (Including Ordinary Shares, Preferred Shares and Other Stocks and Derivative Forms of Stocks)", and the progress has reached the stage of receiving materials.
It is reported that Vimax will submit a prospectus to the Hong Kong Stock Exchange for listing on the main board. Founded in 2014, Vimax is an innovative high-tech enterprise integrating R&D, production and sales, providing one-stop oral care services, with oral care brands - Saky and children's oral care brands - SakyKids.
Fourth, industry events
●Innovent Biologics introduces 3 potential "first-in-class" inhibitors
On January 18, Amagma Therapeutics announced a strategic partnership with Innovent in the field of inflammatory diseases to develop three enzyme-specific inhibitors derived from Amagma's proprietary platform, SEIZMIC. The agreement grants Innovent Bio the exclusive right to develop and commercialize these products in Greater China, while Amagma retains all rights outside of China, and Innonovent will also be a global partner for the production of monoclonal antibodies for clinical research and potential commercial production.
●The domestic ECMO system was successfully used in clinical practice for the first time
Recently, a patient with fulminant myocarditis in Fuwai Hospital of the Chinese Academy of Medical Sciences recovered his heart function and successfully escaped the extracorporeal membrane oxygenation (ECMO) assist. This is the first time that the domestic in vitro cardiopulmonary support auxiliary system has helped patients restore cardiac function in the clinic.
At present, the clinical trial of domestic in vitro cardiopulmonary support auxiliary devices is recruiting subjects in Fuwai Hospital, the patient meets the admission criteria of the trial, and the expert consultation decides to provide venous-arterial (V-A) ECMO support to assist in circulatory respiratory function. After 6 days of ECMO supportive treatment, the patient's cardiac function was significantly restored, the vasoactive drug was gradually reduced, the bedside cardiac ultrasound was observed to restore cardiac function, and the ECMO was successfully withdrawn after the ecmo support flow was gradually reduced. The successful treatment of this patient reflects the ability of Fuwai Hospital to diagnose and treat acute and severe cardiovascular diseases, and also marks the successful clinical use of the domestic ECMO system.
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