1. Policy trends
14 Henan Province Alliance Centralized Procurement: Medical institutions begin to confirm the amount to be distributed
On the 14th, the Shanxi Provincial Pharmaceutical Equipment Centralized Bidding Procurement Network issued the "Notice on Carrying out the Confirmation of the Collective Procurement of the Selected Varieties in the Fourteen Provinces (Autonomous Regions, Municipalities, and Corps) Drug Alliances to Be Distributed". Fill in the selected drugs with the lowest price in Groups A and B, and 50% of the amount to be allocated by the medical institution for this variety will be allocated to the lowest-priced drugs. If there is unallocated content to be allocated, it will be uniformly allocated to the lowest price selected company. In addition, in order to solve the problem of conversion between different specifications in the weighting process, the weighting is carried out according to the content data. The content data is the pre-purchased quantity (tablet/grain/bag/stick) filled in by the medical institution multiplied by the content value (by the variety Specifications) can be calculated, for example: Hospital A fills in 100 tablets of atenolol of 25mg, and the content data is converted to: 100 (pre-purchased amount) * 25 (content value) = 2500mg.
2. Approval of medical devices
●The State Food and Drug Administration approved the registration of 198 medical device products in February
On the 14th, the State Food and Drug Administration issued an announcement on the approval and registration of 198 medical device products. In February 2022, the State Drug Administration approved a total of 198 registered medical device products. Among them, there are 137 domestic third-class medical device products, 36 imported third-class medical device products, 22 imported second-class medical device products, and 3 Hong Kong, Macao and Taiwan medical device products.
● InnoCare BTK inhibitor new indications apply for listing
On the 14th, Nuocheng Jianhua announced that the NMPA Center for Drug Evaluation has accepted the new indication marketing application of its BTK inhibitor orelabrutinib for the treatment of patients with relapsed/refractory Waldenström macroglobulinemia.
3. Capital Market
● Yilian Bio completed $70 million in Series B financing
Recently, Yilian Bio completed a $70 million Series B financing. This round of financing was led by Zhouling Capital, jointly led by Qiming Ventures, and followed by Legend Capital, Zhengxingu Capital and Honghui Fund. The funds raised in this round of financing will be mainly used for the clinical trial development of the company's next-generation antibody conjugated drug product pipeline, as well as the early research and development of new conjugated drugs.
●Yuesai Bio completed nearly 200 million yuan of Pre-A round of financing
On the 14th, Yuesai Bio announced the completion of nearly 200 million yuan in financing. This round of financing was led by Sherpa Investment, co-led by CDH VGC (Innovation and Growth Fund), and jointly invested by Taifu Capital, Kunlun Capital, Hillhouse Ventures, Fosun Pharma, Ruihua Capital and Guofang Capital. This round of financing will be mainly used for the R&D investment of multiple pipelines, the construction of clinical-grade cell product production plants, and the initiation and promotion of related clinical trials.
●Ricco Bio has passed the hearing of the Hong Kong Stock Exchange
On March 14, Jiangsu Ruike Biotechnology Co., Ltd. passed the hearing of the Hong Kong Stock Exchange.
According to the data, it is a vaccine company founded in 2012, dedicated to the research and development and commercialization of subunit vaccines. The company mainly focuses on the research and development of HPV vaccine candidates. The company has established a vaccine portfolio consisting of 12 vaccine candidates, including the company's core product REC603, a recombinant HPV nine-valent vaccine for cervical cancer prevention, which is currently in Phase III clinical trials.
For the years ended December 31, 2019 and 2020 and the nine months ended September 30, 2021, the company's total comprehensive losses for the year/period were RMB 138 million, RMB 179 million and RMB 520 million, respectively; the corresponding R&D The costs were 63.265 million yuan, 131 million yuan and 372 million yuan respectively.
Fourth, industry events
●Berry Gene released products that can screen 153 kinds of genetic diseases
On March 14th, Berry Gene released the expanded carrier screening (standard version) with Xinan, which is based on the latest "Guidelines" of ACMG (American Society for Medical Genetics and Genomics), focusing on the types of genetic diseases that meet the characteristics of the Chinese population , more in line with China's clinical needs, and the test results are more accurate and comprehensive. This new product release will further improve Berry Gene's reproductive health product matrix, provide better protection for couples during pregnancy, early pregnancy, and assisted reproductive populations, and help prenatal and postnatal care.
Carrying Xinan Extended Carrier Screening (Standard Edition) refers to the latest ACMG "Guidelines" to include genes, and at the same time fully considers the carrier rate of Chinese and Asian populations to adjust, and finally includes 129 genes and 153 genetic diseases for screening, covering Metabolic endocrine, nervous system and neuromuscular disease, respiratory, audio-visual and other systems better meet the clinical needs, so that the disease can be selected into science.
1 Drug.com and BGI have reached a new crown antigen detection kit cooperation
On March 14, the digital medicine and health platform 1 Yaowang (Nasdaq: YI) reached a strategic cooperation with Shenzhen Huada Gene (300676) Co., Ltd. The latter's novel coronavirus (2019-nCoV) antigen detection kit (fluorescence immunoassay) Chromatography) will be supplied to the whole country through the 1 Drug Network digital platform, quickly covering the population in demand, and helping the national epidemic prevention and control. Among the 8 companies that signed a strategic cooperation framework agreement in the same period, 1Pharmaceutical.com, as the only online platform, will become the first online retail platform for BGI's new coronavirus antigen detection kit. Since it will take some time for the new crown antigen detection kit to be purchased and put on the shelves, 1 Drug Network will start product pre-sale within this week.
Obama tests positive for coronavirus
According to Xinhua News Agency, former US President Barack Obama said on the 13th that he tested positive for the new crown virus.
Obama posted on social media that day that he recently felt a sore throat, but otherwise felt fine. Both he and his wife, Michelle, have completed the new crown vaccination and received a booster shot. Michelle tested negative for the coronavirus. Obama was born in 1961 and served as President of the United States from 2009 to 2017.
Statistics on the new crown epidemic released by Johns Hopkins University in the United States show that as of the 13th, the cumulative number of confirmed cases of new crown in the United States has exceeded 79.5 million, and the number of deaths is close to 970,000.
21 Health News Daily|The State Food and Drug Administration approved the registration of 198 medical device products in February; Obama tested positive for the new crown
2022 03/15