In the past two weeks (from February 1 to February 13), the important events of investment and financing in the pharmaceutical industry include: the National Medical Insurance Bureau strives to launch the alliance reform of local centralized collection of dental implants in the first half of the year; The State Food and Drug Administration approved Pfizer covid-19 virus treatment drug import registration with emergency conditions; Xinda biological domestic PD-1 breaks through FDA; The stock price of YaoMing bio entered the UVL list of the United States; Hong Kong Asia medical group received a round D financing of US $400 million. Sci tech Innovation Board daily is committed to building the first platform for sci tech innovation reporting and service in China. If you have investment and financing clues and reporting needs, you can contact us through the following email: [email protected]. 。 On February 11, the State Information Office held a regular policy briefing. Chen Jinfu, deputy director of the State Medical Security Bureau, said at the meeting that dental implant is an important method of dental restoration and treatment, and the social demand is also great. Of course, medical institutions also provide a lot of services. Since the beginning of last year, Sichuan has organized an inter provincial alliance to study the procedures of centralized dental implant collection. Now the scheme is basically mature, and the opinions of clinical, enterprises and local governments have been widely listened to. It is prepared to launch such an alliance reform of centralized dental implant collection in the first half of this year. In fact, it is also a layout led by the state, A centralized mining method for dental implant exploration. The Beijing Tianjin Hebei “3 + n” alliance issued the work plan for the joint procurement and use of orthopaedic trauma medical consumables. Through the Beijing Tianjin Hebei “3 + n” alliance, the joint procurement of orthopaedic trauma medical consumables should be carried out to ensure the supply and reasonable price, so as to reduce the price of orthopaedic trauma medical consumables and reduce the burden of patients’ medical expenses; Reduce transaction costs, purify the circulation environment and improve the industry ecology; Standardize the purchase and use of consumables and support the reform of public hospitals; Explore and improve the centralized procurement mechanism of medical consumables and the price formation mechanism of consumables dominated by the market. In this centralized procurement, the varieties of orthopedic trauma medical consumables such as bone sector and supporting screws, intramedullary nails and accessories, hollow (hollow) screws and so on. On February 11, the State Food and Drug Administration conducted emergency review and approval in accordance with the relevant provisions of the drug administration law and the special drug approval procedures, and approved the import registration of the combined packaging of nevitavir tablets / ritonavir tablets (i.e. paxlovid) of Pfizer covid-19 virus treatment drug conditionally. This product is an oral small molecule COVID-19 virus therapeutic agent for the treatment of mild to moderate New Coronavirus pneumonia (COVID-19) in adults with severe risk factors, such as elderly, chronic kidney disease, diabetes, cardiovascular disease, and chronic lung disease. The US Food and Drug Administration (FDA) recently held a meeting of the tumor drug advisory committee (ODAC) to review the results of the PD-1 antibody cindilimab cooperated by Cinda biology and Lilly pharmaceutical. ODAC voted 14:1 and believed that cindilimab should be supplemented by clinical trials in order to be approved. The declared indication of BLA is cindilimab injection combined with pemetrexed and platinum for the first-line treatment of non-squamous non-small cell lung cancer, which is mainly based on the data of orient-11 clinical phase III trial carried out in China. The committee voted to recommend additional clinical trials before approval to demonstrate the applicability of sindelimab in the U.S. population and medical practice in the United States. Cindilimab is an innovative PD-1 inhibitor developed and commercialized by Cinda and Lilly pharmaceutical. On February 7, the US Department of Commerce listed 33 Chinese companies on the “unverified list (UVL)”, including two subsidiaries of cdmo enterprise Yaoming Biology (02269. HK) in Shanghai and Wuxi. For Yaoming bio, the products mainly subject to import restrictions include bioreactors and other related containers and chemicals with potential to manufacture biochemical weapons. Specifically, some hardware controllers of bioreactors and ultrafiltration membrane packages (hollow fiber filters). Affected by this, the market was like a frightened bird: Yaoming biology once fell to 30% in the intraday trading and suspended trading at noon on the 8th, saying that “the announcement constituting the company’s inside information to be published”. Wuxi Apptec Co.Ltd(603259) was also wrongly injured by the news. A shares fell by the limit and H shares fell by 26% for a time. In the emergency statement “not included in UVL”, the share price gradually rose and closed down to 11.36%. On January 24, the arcov phase I data disclosed by Aibo biology showed that the vaccine had a high adverse reaction rate, mainly fever. In the phase I clinical trial conducted by Shulan (Hangzhou) hospital, the vaccinators were injected with 5 doses respectively μ g、10 μ g、15 μ g、20 μ g、25 μ G dose of arcov, the proportion of fever in each dose group was 5%, 65%, 85%, 95% and 100% respectively. Some pharmaceutical industry analysts said that the dose will affect the effectiveness when the dose reaches 10 μ After g, “basically more than half of people will have a fever after vaccination with arcov, and it is a high fever of more than 38.5 degrees.” The analyst said that safety is the bottom line of the vaccine, and high fever may “dissuade” many potential vaccinators. Walvax Biotechnology Co.Ltd(300142) said on the interactive platform that the covid-19 mRNA vaccine project jointly developed by the company and Aibo biology is normally promoted according to the agreement on technical development cooperation signed by both parties, and there is no termination. At present, the relevant work of the international multicenter phase III clinical trial of the vaccine is being carried out simultaneously in Mexico, Indonesia, the Philippines, Nepal, Guangxi and Yunnan, China. The recruitment and vaccination of Chinese clinical enrollment have been completed, and the follow-up serum sampling and sample testing are being carried out. All the work of the international clinical trial is progressing normally. The company said that it needs to sell its products on the overseas testing platforms of vi19-406} company, and that it has been actively selling its products on the testing platforms of vi19-406} company in Italy. Shenzhen Everbest Machinery Industry Co.Ltd(002980) announced that the company New Coronavirus antigen rapid detection kit was recently obtained from the European Union CE certification. The product name is: SARS-CoV-2 Antigen Rapid Detection Kit (Chinese Translation: New Coronavirus antigen rapid detection kit). Bgi Genomics Co.Ltd(300676) announced that New Coronavirus’s antigen detection kit (colloidal gold method), a wholly owned subsidiary of BGI Europe A/S, was approved by the Saudi Food Drug Authority (English version of SFDA) in Chinese. The antigen detection is directly aimed at the specific protein (i.e. antigen) in the virus, which can quickly detect positive cases in the acute infection period. This kit is used by professionals in medical institutions and testing stations to detect the virus antigen in oropharyngeal swab and nasopharyngeal swab samples. It can carry out early diversion and rapid management for suspected people. It is an important supplement to the existing detection methods. According to the Shenzhen Yhlo Biotech Co.Ltd(688575) announcement, the New Coronavirus antigen detection kit of the Japanese Medical Research Institute of Japan (MBL) has obtained the license for production and sale of external diagnostic products (Japan’s PMDA certification) issued by Japan PMDA in February 10th.
The company is designated manufacturer of MBL New Coronavirus antigen detection kit. After obtaining the PMDA certification, the product will be sold in Japan, and can be used for medical testing and home self testing. Shanghai Sailun Biotechnology Co., Ltd. has been registered and is expected to be listed on the science and innovation board in the near future. Salem biology plans to raise 400 million yuan, of which 200 million yuan is used for R & D projects of special drugs and innovative technologies, 150 million yuan is used for plant expansion project of Shanghai Salem Biotechnology Co., Ltd., and 50 million yuan is used for emergency (emergency) drug first aid network service project. Founded in 1999, Salem bio is a biomedical enterprise focusing on the field of antiserum and antitoxin. It is committed to the research, development, production and sales of preventive and therapeutic drugs in the field of biotoxin and biosafety. Asian cardiovascular specialty medical Brand Hong Kong Asia Medical Group recently completed round D financing of US $400 million. This round of financing was led by Country Garden venture capital and Chunhua capital, followed by Taikang Life Insurance, ICBC international, Agricultural Bank of China International, Bank of Communications International, Hudson Bay capital and Sherpa investment, and continued to be added by the old shareholders Junlian capital and pan Atlantic China Welding Consumables Inc(600558) investment group. After the current round of financing, Asian medical will continue to plan new changes in services, guided by meeting the needs of patients, and move towards building a world-class cardiology group integrating clinical treatment, patient care, research and education. Synthetic biology enterprise pilotage biology has continuously completed the financing of round C and round C + of more than 400 million yuan. Round C was jointly led by Hillhouse venture capital and Sherpa investment, followed by GF Qianhe, houxin health investment, Hunan Caixin industry fund, green capital and old shareholder Yuanhe holding. Round C + financing is exclusively invested by Lilly Asia Fund. The financing will be used to accelerate the commercialization of the existing products of pilot biology and promote the expansion of R & D pipelines and Hunan production base. Danxu biology recently completed nearly 300 million yuan of round B financing. This round of financing was jointly led by Junlian capital and Heyu capital, followed by Jianyi capital, guokejia and other parties. At the same time, the old shareholders Gaoling venture capital, Huagai capital and the management made additional investment. The financing will be used to develop covid-19 pneumonia neutralizing antibody and further enhance the new pipeline. Kaisi Kaidi announced the completion of nearly 100 million yuan pre-A + round of financing. This round of financing is led by the fund of the new investor Xihu innovation (Hangzhou) Equity Investment Co., Ltd., and the old shareholders such as Gaorong capital, Fuhui venture capital and Jindi capital continue to follow. It is reported that the company will use the funds obtained from this round of financing to accelerate the follow-up research and development of a variety of core products of the company. Kaisi Kaidi is characterized by the original innovative research and development of drugs targeting nuclear receptors and G protein coupled receptors (GPCR). It focuses on the unmet major clinical needs such as metabolic diseases and inflammatory diseases, and focuses on the early discovery, drug development and subsequent commercialization of innovative drugs. Yousanuo biology announced that it had recently completed a round of financing of RMB 160 million, led by Jingwei venture capital, and all Angel round shareholders such as Kaifeng venture capital, northern lights venture capital, lichen investment and Chengdu Tianfu international biological city fund participated in this round of financing. This round of financing will be mainly used to further improve yousanuo’s unique universal car-t cell technology platform cbt-x20, prepare the Sino US ind declaration of core product at19 and the construction of the company’s scientific research and production facilities.
