This week, the domestic new crown epidemic has continued to fluctuate. According to the latest report from the National Health and Medical Commission, on July 30, there were 116 new confirmed cases nationwide, and there are currently 1,731 confirmed cases in the country.
At the national level, the State Council’s joint prevention and control mechanism requires promoting national mutual recognition of new crown nucleic acid test results. Beijing has stipulated that the purchase of “four types of drugs” such as antipyretic and cough relief will no longer be “pop-up” as long as the nucleic acid is carried out within 72 hours. Since July 30, Jiangxi, those who have not undergone nucleic acid testing within 48 hours will be assigned a yellow code management.
In the first half of this year, the number of IPOs of pharmaceutical companies was only 21, a decrease of 8 from the same period of the previous year. This week, the China Securities Regulatory Commission officially stipulated the content and format of the prospectus of drug and medical device companies, and the management of the listing of pharmaceutical companies will be stricter in the future.
The domestic new crown drugs have achieved great results. The real biological “Azvudine” was approved for marketing, becoming the first domestic oral drug for the new crown; Tengsheng Boyao announced that the company’s new crown neutralizing antibody was resistant to Omicron BA.4/5 and BA.2.12.1 subtypes The mutants maintained neutralizing activity.
More information is organized as follows:
Heavyweight Policy
1. The National Health Commission sets up the National Psychiatric Center
On July 29, the National Health and Medical Commission issued an announcement stating that according to the relevant arrangements for the establishment of national medical centers and national regional medical centers during the “14th Five-Year Plan” period, the National Medical Center and the National Regional Medical Center will be established in Beijing, Shanghai and Hunan. In the three provinces, the Sixth Hospital of Peking University, the Shanghai Mental Health Center, the Second Xiangya Hospital of Central South University and other institutions are the main bodies to set up the National Medical Center for Mental Diseases.
The announcement also stated that in addition to providing business guidance for the work of the medical center in the future, the National Health and Health Commission will also issue special tasks and supporting funds, and conduct performance evaluations on the implementation of the medical center’s work tasks every year. and supervision.
2. The two ministries jointly issued a document to strengthen drug safety supervision
On July 27, the National Health Commission and the State Administration of Traditional Chinese Medicine jointly issued the “Notice on Further Strengthening Drug Safety Management and Improving the Level of Rational Drug Use”. In terms of testing and other aspects, it is required to strengthen the management of drug safety.
The “Notice” emphasizes the need to strengthen key monitoring of the use and management of rational drug use, antimicrobial drugs, anti-tumor drugs, proton pump inhibitors, traditional Chinese medicine injections, etc. . In addition, when selecting medicines for children, the scope of medicines can be increased without being restricted by the rules of “one product, two regulations” and the total number of medicines.
3. Shenzhen has a maximum subsidy of 50 million yuan to support pharmaceutical companies
On July 26, the Shenzhen Development and Reform Commission officially issued a notice of three policy measures including “Several Measures for Shenzhen to Promote the High-Quality Development of Biomedical Industry Clusters” to support Shenzhen’s expansion Strong biopharmaceutical industry.
The “Measures” specifically mentioned that it is necessary to accelerate the construction of major industry public service platforms such as CRO, CDMO, GLP, drug discovery platform, MAH comprehensive service platform, and press 40% of the total project investment will be funded, up to a maximum of 50 million yuan. In addition, major industrial projects that tackle key “stuck neck” core technologies such as new target chemical drugs, antibody drugs, and genetic drugs will be funded in stages according to 40% of the total project investment, with a maximum of no more than 300 million yuan.
Industry Events
1. Wu Zunyou: Monkeypox will not be widespread in China
On July 24, after Taiwan reported its first confirmed case of monkeypox, Wu Zunyou, chief epidemiologist of the Chinese Center for Disease Control and Prevention, posted on Weibo on the 25th that since this monkeypox outbreak occurred From the perspective of the spread of European and American countries, it is only a matter of time before the introduction of monkeypox into the mainland, Hong Kong and Macau. Due to the limitation of the mode of transmission, the spread of monkeypox and the scope of the population will be far from that of the new crown epidemic. The epidemic will not cause a large-scale epidemic in our country.
In addition, Wu Zunyou said that the earliest monkeypox outbreaks in mainland China are likely to be men who have sex with men, and then spread to other populations. In terms of prevention, one is to avoid contact with infected animals, and the other is to avoid direct contact with infected people as much as possible.
2. The China Securities Regulatory Commission has added more stringent IPO disclosure requirements
On July 29, the China Securities Regulatory Commission officially released the “Guidelines for the Content and Format of Prospectus for Companies Engaged in Drug and Medical Device Business”. The content and format of disclosure and explanation required by drug and device companies to be listed are stipulated.
It is worth mentioning that with regard to product disclosure, the Guidelines require companies to publish “comparisons in terms of safety, efficacy, accessibility, etc. “. In addition, the “Guidelines” also stipulate that companies need to disclose in their prospectuses “A substantial drop in operating income or net profit due to the expiration of patent rights“.
3. The Alzheimer’s disease blockbuster paper is suspected of falsification
On July 21, “Science” published an investigation saying that Sylvain Lesner, a star scholar in the field of Alzheimer’s disease (AD) and a neuroscientist at the University of Minnesota Twin Cities A number of papers are suspected of academic fraud, including a foundational study related to the “beta amyloid hypothesis” of AD pathogenesis. Science said the paper “misled worldwide Alzheimer’s research for 16 years“.
Academic fraud is common, and the reason why the “Science” investigation has attracted widespread attention may be related to the repeated failures and disputes in drug development in recent years: Abroad, Bojian “first after 13 years” Approved AD drug “Aduhelm” hit by backlashBoycott; Domestic, Green Valley’s “971” is also frequently questioned.
But according to China News Weekly, mostly neuroscientists said that even if these papers turned out to be fake, the impact on academia and industry would be “not as much as the outside world thinks.” so serious”.
4. Merger of two synthetic biology companies
On July 25, Ginkgo and Zymergen, two synthetic biology companies in the United States, announced that they have reached an agreement. Ginkgo will acquire Zymergen in an all-stock transaction valued at approximately $300 million. .
Ginkgo and Zymergen were both founded around 2013, and together with Amyris, who developed biofuels, became the “Big Three in Synthetic Biology.” Both Ginkgo and Zymergen are positioned to build platform companies, creating a bio-manufacturing platform that operates efficiently with the help of machine learning and other means. However, Ginkgo focuses on platform building, while Zymergen focuses on product development. These two models basically represent the current R&D path of synthetic biology companies.
New Drug Inventory
1. The world’s first AAV gene therapy directly injected into the brain is on the market
On July 21, PTC Therapeutics, a NASDAQ-listed company, announced that the European Commission approved the listing of the gene therapy Upstaza for the treatment of aromatic L-amino acid decarboxylase deficiency (AADCD). The world’s first approved gene therapy injected directly into the brain.
Upstaza is a one-time treatment of ji beverages, its first patient was treated in 2010. Data released by PTC Therapeutics showed that patients received Upstaza treatment for 3 months, and the motor function improved effectively, and the effect lasted for 10 years after receiving the treatment. In addition, cognitive performance improved in all treated patients.
2. The world’s only monkeypox vaccine launched in Europe
On July 25, Bavarian Nordic, a Danish biopharmaceutical company, announced that the European Commission has approved the company’s I monkeypox vaccine mvanex, which is available to all EU member states, as well as Iceland, Liechtenstein and Norway. use.
Imvanex, developed by Bavarian Nordic in partnership with the US government, was originally a non-replicating smallpox vaccine, but animal data show it is effective in preventing monkeypox. This vaccine is currently approved in the United States and Canada for the prevention of monkeypox.
3. IDEAYA Announces Clinical Data of New Cancer Therapy
On July 28, IDEAYA Biosciences announced that IDE397, a small molecule MAT2A inhibitor developed based on the principle of “synthetic lethality”, obtained positive results in Phase I/II clinical trials: accepting high Circulating tumor levels were significantly reduced in 75% of dose-treated patients.
“Synthetic lethality” is a popular anti-cancer drug development concept in recent years. Cancer cells, in principle, carry a large number of genetic mutations that give them characteristics that healthy cells do not possess, but may also create unique weaknesses that can be studied to kill cancer cells while protecting healthy cells from harm. .
#monkeypox vaccine##domestic new crown medicine##psychiatry center#