Morning, here is "21 Jianxun Daily". Welcome to pay attention to the latest events in the pharmaceutical and health industry with the 21st Century Business Herald new health team!
1. Policy trends
●State Medical Administration: 45 batches of cosmetics random inspections do not meet the regulations
On November 22, the State Medical Administration issued a notice on 45 batches of cosmetics that do not meet the regulations (No. 56 of 2022).
During the 2022 national cosmetic supervision and random inspection, after inspection by Hainan Provincial Drug Inspection Institute and other units, the product label labeled , 45 batches of cosmetics (including toothpaste, the same below) such as Saisi Zhixiu Run Hei Lu (Natural Black) produced by Guangzhou Saisi Cosmetics Co., Ltd. do not comply with the regulations.
According to the " Cosmetics Supervision and Administration Regulations " and " Cosmetics Production and Administration Measures ", the State Food and Drug Administration requires the Guangdong and Jiangsu provinces to file a case for the registrants, filingers, entrusted production enterprises, and domestic responsible persons involved in the above 45 batches of cosmetics that do not meet the regulations, and order relevant enterprises to immediately take risk control measures and carry out self-inspection and rectification; the drug supervision and administration departments of each province (autonomous region, municipality) order relevant cosmetic operators to immediately stop operating the above cosmetics, investigate their purchase inspection records in accordance with the law, and trace the source of the illegal products; if illegal acts are found, they shall be seriously investigated and dealt with in accordance with the law; if suspected of committing a crime, they shall be transferred to the public security organs in accordance with the law.
●National Health Commission: 4 new grassroots comprehensive health pilot zones
On November 21, the General Office of the National Health Commission issued the "Notice on Establishing a Dynamic Adjustment Mechanism to Accelerate the Construction of Grassroots Comprehensive Health Pilot Zones".
notice clearly stated that after research, four experimental areas including Miyun District, Beijing, Shangsi County, Fangchenggang City, Guangxi Zhuang Autonomous Region, Dongfang City, Hainan Province, and Xishui County, Zunyi City, Guizhou Province were added. Our commission will implement unified management of 8 original experimental areas and 4 new experimental areas.
The Health Commission will establish a dynamic adjustment mechanism for the pilot zone, consider multiple factors according to work needs, and timely include counties (cities, districts) that meet the conditions in the pilot zone or alternate test zone. At the same time, the construction of each experimental zone will be evaluated. The experimental zones that ranked the last two for two consecutive years will be adjusted to the candidate experimental zone, and the construction results of the candidate experimental zone will be adjusted to the experimental zone. The Health Commission has studied and formulated the "Evaluation Content and Key Points of Construction of Grassroots Health Comprehensive Pilot Zones (Trial)" (see attachment). From 2023, experts or entrusted third parties to conduct evaluation and analysis on the construction of the pilot zone every year. The evaluation results will be used as the basis for adjusting the pilot zone.
2. Drug and equipment approval
● Roche's new anti-influenza drug "Mabaloxavir" new dosage form applied for marketing in China
On November 22, the official website of the China National Medical Products Administration's Drug Review Center (CDE) announced that Roche submitted an application for marketing of mabaloxavir dry suspension and was accepted. Public information shows that mabaloxavir is a single-dose oral drug "first-in-class" and is also the first new anti-influenza drug approved by the US FDA in the past 20 years with an innovative mechanism of action. Earlier, mabalovsavir films have been approved for sale in China.
●Legend Bio solid tumor CAR-T product was approved in the United States for clinical
November 21,Legend Bio announced that the US FDA has approved the application for the clinical trial (IND) of its under-research product LB2102. LB2102 is an autologous chimeric antigen receptor T cell (CAR-T) therapy for the treatment of adult patients with extensive stage small cell lung cancer (SCLC).
●Sandiji's third 3D-printed drug was approved in the United States for clinical
Recently, Nanjing Sandiji Pharmaceutical Technology Co., Ltd. announced that the company's third 3D-printed drug product T21 independently developed has obtained the clinical trial approval (IND) of the US FDA, which is the third IND approved in FDA within two years. T21 uses 3D printing technology to achieve accurate colon targeted delivery. It reflects the diversity of in Triticum in drug delivery technology , verifying the rich application scenarios of emerging technology in product development.
3, Capital Market
●Goshi Medical passed the hearing of the Hong Kong Stock Exchange
November 20, Gaush Meditech Ltd, a ophthalmic medical device provider from Beijing, disclosed its prospectus after passing the hearing on the Hong Kong Stock Exchange. It may soon start its prospectus and listing. Morgan Stanley and Haitong International are its joint sponsors.
Geops Medical was founded in 1998. As a comprehensive ophthalmic medical device provider, its product portfolio covers seven ophthalmic subspecialties that use ophthalmic medical devices for diagnosis, treatment or surgery (fundity disease, cataract , refractive error , glaucoma , ophthalmic surface disease, ophthalmic vision, pediatric ophthalmology).
●Ark Jianke submitted an IPO prospectus to the Hong Kong Stock Exchange
November 21, Ark Yunkang Holdings Co., Ltd. (Ark Jianke) officially submitted a prospectus to the Hong Kong Stock Exchange, intending to list on the main board of the Hong Kong Stock Exchange, with Citigroup , UBS Group and Agriculture Bank International serving as joint sponsors. Founded in 2015, Ark Jianke focuses on chronic disease management, and its core businesses can be divided into comprehensive medical services and online retail pharmacies services. Comprehensive medical services include follow-up doctor consultation and electronic prescription services conducted by registered doctors and internal medical professionals through Ark Jianke's H2H service platform; online retail pharmacies services refer to providing medical and health care products directly to customers.
●"Yasmao""Yongce Medical" actual controller was filed by the China Securities Regulatory Commission
Tongce Medical recently issued an announcement that the actual controller and chairman of Tongce Medical Mr. Lu Jianming has received the "Notice of Filing a Case". According to the " Securities Law of the People's Republic of China " and other laws and regulations, because Mr. Lu Jianming is suspected of illegal information disclosure, the China Securities Regulatory Commission decided to file a case against Mr. Lu Jianming.
According to the previous announcement, the relevant content of the case filing mainly involves the No. 1 Fund Zhejiang Tongce No. 1 Investment Partnership (Limited Partnership). From October 19 to December 30, 2021, the company had non-operating capital transactions with the enterprises controlled by the actual controller, involving an amount of approximately 143 million yuan.
4. Industry events
●Shanghai Stock Exchange . Shenzhen Stock Exchange: Strict review and prudently promote nucleic acid testing companies listing
On November 21, the Shanghai Stock Exchange and the Shenzhen Stock Exchange respectively released the "Relevant person in charge of the Shanghai Stock Exchange answers questions from reporters" and "Shenzhen Stock Exchange spokesperson answers questions from reporters", both of which released a high attitude of paying close attention to the listing applications of nucleic acid testing companies and insisting on strict review.
Among them, the relevant person in charge of the Shanghai Stock Exchange said that we have noticed the relevant reports. We pay close attention to the listing applications of nucleic acid testing companies and insist on strict review, especially the company's scientific and technological innovation attributes and sustainable operation capabilities. Based on the issuance and listing conditions and review standards of Science and Technology Innovation Board , the company's issuance and listing application was carefully reviewed, focusing on its scientific and technological innovation attributes, the correlation between nucleic acid testing-related businesses and main businesses, the sustainability of related revenue, and whether the company still meets the issuance and listing conditions after excluding these business revenues, etc., and the company is required to disclose risks. The Shanghai Stock Exchange will continue to conscientiously implement the decisions and deployments of the CPC Central Committee and the State Council and the work requirements of the China Securities Regulatory Commission, adhere to the positioning of the Science and Technology Innovation Board, strictly control market access, and prudently promote the issuance and listing of relevant enterprises.
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