01 List of blockbuster policies
1. The State Food and Drug Administration requires two types of Chinese medicines to revise the product specifications
On December 9, the State Food and Drug Administration issued an announcement requiring Xiao Chai Hu preparation and Ding Gui'er navel patch to modify the product specification. This is the first time since the release of the "Technical Guidelines for the Revision of the Safety Information Item Content of Listed Chinese Medicine Instructions" on October 20, and the State Food and Drug Administration has required the chinese medicine varieties to modify the instructions.
The Health Bureau noted that the two announcements this time, one is for all preparations related to Xiao Chai Hu, involving China Resources Sanjiu, Tongrentang, Baiyun mountain and other enterprises, a total of 114 registered varieties, the scope of influence is very wide; the other is for exclusive varieties, the announcement of Ding Gui'er navel patch is the exclusive variety of Yabao Pharmaceutical, mainly relying on out-of-hospital retail channels.
The state's supervision of traditional Chinese medicines will become more and more stringent, and after effective clinical verification, the contraindications and adverse reactions to use are clear, and it has also become an important prerequisite for the continued use of traditional Chinese medicines.
2. The State Food and Drug Administration issued 19 medical device industry standards
On December 10, the State Food and Drug Administration issued 19 medical device industry standards, including cardiovascular implants and hepatitis B antibody detection kits, involving standard numbers, names, scope of application and implementation dates.
The Bureau noted that only 7 of the 19 industry standards were revised, and the rest were newly developed standards, involving in vitro diagnostic testing systems, blood gas analyzers, etc. Among them, the "respiratory virus multiple nucleic acid detection kit" that has been widely used due to the new crown epidemic has also formulated corresponding industry standards and will be implemented from December 1, 2022.
3. The State Council strengthens the prevention and control of the new crown epidemic in port cities
On December 11, the State Council issued a notice in response to the joint prevention and control mechanism of the novel coronavirus pneumonia epidemic, requiring that under the leadership of the joint prevention and control mechanism of various localities, the prevention and control of the new crown be strengthened in port cities. Including: setting up a prevention and control buffer zone in the jurisdiction, including nucleic acid testing in the mandatory inspection items, promoting the "14+7+7" model for the prevention and control of high-risk posts, and reducing express delivery items from countries with serious epidemics.
At the same time, the joint prevention and control mechanism also requires local health and disease control to coordinate with the drug regulatory departments to evaluate and supervise nucleic acid testing institutions, carry out spot checks, punish violations of laws and regulations, and ensure the reliability and authenticity of test results.
4. The State Food and Drug Administration supervises the research and development of diet drugs
On December 8, the National Drug Review Center issued the Technical Guidelines for Clinical Trials of Weight Control Drugs to standardize clinical research design and related technical requirements. The National Drug Review Center said the guidelines were introduced to encourage and promote the development of weight control drugs.
According to the Report on the Nutrition and Chronic Disease Status of Chinese Residents (2020) released by the State Council's New Office in December 2020, more than half of China's adults are already overweight or obese. In this case, weight control has become one of the most urgent clinical needs in China.
02 Major events in medicine and health
1. The State Food and Drug Administration held an exchange meeting on the supervision of online sales of medical devices
On December 9, the State Food and Drug Administration invited the heads of drug supervision in various provinces and the heads of the head medical device online sales enterprises to participate in the "Medical Device Network Sales Supervision Work Exchange Meeting", and Meituan, Ali, and Jingdong Health all reported their online sales management experience.
Among them, the supervision model of Jingdong Health is "intelligent system + manual review", and Meituan has established a "business learning center" to educate businesses on laws and regulations. Alibaba Health went a step further, adopting the joint governance of government and enterprises, and opened the "Red Shield Cloud Bridge" system with the provincial drug regulatory department to regularly report illegal clues.
2. Di zhe pharmaceutical and other 3 companies listed and broken
On December 10, Four enterprises, Beihai Kangcheng, Dizhe Pharmaceutical, Gushengtang and Gloria Ying, were listed on the Shanghai Stock Exchange or the Hong Kong Stock Exchange, however, all 3 companies except Gushengtang broke down, and the listing of some enterprises was urgently suspended.
Beihai Kangcheng is known as the "first stock of rare diseases", with a decline of 27% on the first day of listing. Backed by AstraZeneca's Dizhe Pharmaceutical, the stock price fell by 22% on the same day, and some analysts believe that the pharmaceutical stocks listed on the Hong Kong stock market generally fell sharply, not limited to these two companies, and the heat of capital chasing medicine has also slowed down.
3. Hebei, Jiangsu and Heilongjiang jicai renewal
From December 9 to 10, Jiangsu, Heilongjiang and Hebei successively issued announcements on the renewal of drug collection contracts.
All three provinces have renewed their contracts by means of inquiry and bidding. Among them, Hebei clearly requires that the quotation of enterprises shall not be higher than the lowest national hanging net price, as well as the lowest price selected by the provincial collection and procurement. Jiangsu requires enterprises to inquire about the lower limit, which must not be higher than 1.5 times the minimum selected price of the national collection and mining, and Shaanxi collection and mining also adopts the same standard.
According to incomplete statistics from the Health Bureau, as of December 12, at least 14 provinces and regions across the country have successively carried out collective procurement and renewal.
03 Weekly inventory of new drugs
1. Hengrui PD-1 was approved for the 6th indication
On December 10, the official website of the State Food and Drug Administration showed that Hengrui Pharmaceutical's PD-1 carellizumab was approved for two new indications, namely first-line treatment of esophageal cancer and squamous non-small cell lung cancer. Since its launch in May 2019, it has received a total of 6 approvals.
This week, Hengrui's two competitors in China, Cinda and Junshi, have been exposed to the cancellation of the PD-1 joint promotion agreement with multinational pharmaceutical companies, and after participating in the medical insurance negotiations and renewal, it is still unknown whether Hengrui can continue the domestic PD-1 sales crown results.
2. Frontier biological new crown drugs were approved for clinical trials
After Tengsheng Huachuang was approved as the first new crown neutralizing antibody drug in China, on December 10, Frontier Biologics issued an announcement that its new coronavirus injection drug FB2001 has been approved for clinical trial by the State Food and Drug Administration, and it has also launched Phase I clinical trials in the United States.
Frontier Biology is known to the public for its self-developed new anti-AIDS drug Aikenin, which has entered the national medical insurance directory, and its sales in the first three quarters of 2021 reached 34 million yuan.
3. Zaiding Pharmaceutical Antibacterial Class 1 new drug will be approved soon
On December 10, the official website of the State Food and Drug Administration showed that Zaiding Pharmaceutical's omarcycline toluenesulfonate is already in the approval stage, which is a systemic antibacterial drug, which belongs to class 1 new drugs for skin infections and can solve the problem of tetracycline resistance.
In April 2017, Zaiding Pharmaceutical reached a cooperation agreement with Paratek Pharmaceuticals to acquire the right to develop the drug in China with a down payment of US$7.5 million.
4. Gan&Lee Pharmaceutical's new antidiabetic drug was approved for clinical trial in the United States
On December 6, Gan&Lee Pharmaceutical announced that one of its new hypoglycemic drugs, GZR18, has been approved for clinical trials in the United States. The announcement shows that the drug is a glucagon-like peptide 1 receptor agonist drug, injected once a week, belongs to the long-acting hypoglycemic drug, and the pre-application indication is type 2 diabetes.
Gan&Lee Pharmaceutical is the representative of the three generations of domestic insulin, in this collection of the whole line of winning the bid, its insulin glargine is the lowest price in the industry, on the basis of consolidating its own position in the domestic insulin, Gan&Lee Pharmaceutical has repeatedly said: innovative hypoglycemic drugs are also a potential market, need to actively participate, domestic competition will inevitably continue overseas.
Text | David
Operational | Yan Ning
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