After the release of the "14th Five-Year Plan for the Development of Traditional Chinese Medicine", the progress of promoting the development of traditional Chinese medicine in various regions and relevant departments has been further accelerated.
This week, the Drug Review Center of the State Food and Drug Administration took the lead in promoting the construction of the evidence system for the registration and evaluation of Chinese medicines; at the practical level, Zhejiang's development plan for Chinese medicine services in this region was demonstrated by the Chinese Medicine Administration as a case study to provide direction for the improvement of Chinese medicine services in other places.
Progress in the vaccine industry is also advancing rapidly. At the beginning of April, CSPC Pharmaceutical Group, CanSino and China Resources Pharmaceutical have successively stepped into the field of mRNA vaccines, and there are no vaccines under the mRNA technology route among the 6 new crown vaccines approved for marketing in China. As the pandemic came to an end, the tracks began to get crowded.
This week, the business and personnel changes of the head company are also continuing. Among them, Takeda Pharmaceutical China began to rearrange the domestic digestive field; Jingdong Health, a big man in the Internet medical field, announced a new round of high-level blood changes...
The Health Bureau has compiled more hot information this week as follows:
Blockbuster policy
1. The Drug Review Center promotes the construction of a evidence system for the registration and evaluation of Chinese medicines
On April 6, the Drug Review Center issued a document saying that it had organized the drafting of the "Technical Guidelines for the Clinical Research and Development of New Drugs for Compound Preparations of Traditional Chinese Medicines Based on Human Experience", and solicited opinions from networks and expert representatives in March and April respectively.
According to the Drug Review Center, a total of 50 expert representatives solicited opinions, namely TCM clinical experts, TCM clinical trial institution experts, TCM methodological transfer, statistical experts and representatives of TCM production enterprises. The construction of the evidence system for the registration and evaluation of Chinese medicines will further standardize the development of the Chinese medicine industry and promote the overall upgrading of the Chinese medicine industry chain.
2. The results of the collection and collection of proprietary Chinese medicines in the six provinces alliance were announced
On April 8, the Guangdong Provincial Drug Trading Center issued the Notice on the Proposed Selection/Alternative Results of the Centralized Procurement of Guangdong Alliance Qingkailing and Other Proprietary Chinese Medicines.
A total of 53 varieties were participated in the collection, and finally 124 production enterprises were selected, and 56 production enterprises entered the proposed candidate list. Among them, the competition between ginkgo biloba leaves and compound danshen tablets is the most intense, and Shanghai Kaibao Xinyi (Xinxiang) Pharmaceutical Co., Ltd. 0.32g / tablet of compound danshen tablets is planned to be selected at a price of 0.0435 yuan per piece, less than five cents.
The six provinces involved in this collection are Guangdong, Shanxi, Henan, Hainan, Ningxia and Qinghai, which is one of the earliest alliances in China to carry out the collection of proprietary Chinese medicines. According to pre-harvest disclosure, the pre-order volume of the first year of the alliance collection was 3.995 billion yuan (pieces/bags/bags/sticks).
3. Tianjin implements artificial joint collection and collection, and clarifies the highest payment standards for products
On April 8, Tianjin Pharmaceutical Procurement Center issued the "Notice on Implementing the Centralized Procurement and Use of Artificial Joints Organized by the State", announcing the results of the selection of artificial joints and the procurement of artificial joints, which began to be implemented on April 10.
According to the Notice, Tianjin has publicized the highest payment standards for related products:
The maximum payment standard for the alloy-polyethylene primary full hip system is 8460 yuan per set;
The maximum payment standard for the ceramic-polyethylene primary full hip system is 8500 yuan per set;
The maximum payment standard for the ceramic-ceramic primary full hip system is 9920 yuan per set;
The maximum payment standard for other types of initial full hip systems is 9920 yuan per set;
When using acetabular screws that exceed the standard number of system category, the maximum payable standard for acetabular screws is $450 per screw. The maximum payment standard for the initial full knee system is 7199 yuan per set;
The maximum payment standard for the semi-hip product system is 8290 yuan per set, and the maximum payment standard for the single condyle product system is 9360 yuan per set.
In addition, for non-selected artificial joints, medical insurance payment is paid at the highest selected price of the selected product in the same category; if it is not higher than the maximum payment standard, the medical insurance fund pays proportionally.
4. Zhejiang: By 2025, 100% coverage of traditional Chinese medicine halls in township health centers will be realized
On April 8, the State Administration of Traditional Chinese Medicine updated the development of local traditional Chinese medicine, and the Zhejiang Provincial Health Commission, the Provincial Administration of Traditional Chinese Medicine and other five departments jointly issued the "Several Opinions on Improving the Service Capacity of Traditional Chinese Medicine and Promoting the High-quality and Balanced Development of Traditional Chinese Medicine", and the in-depth construction of the national demonstration zone for comprehensive reform of traditional Chinese medicine has been valued by the Administration of Traditional Chinese Medicine.
According to the Opinions, by 2025, Zhejiang Province will achieve 100% of township health centers to set up traditional Chinese medicine halls, more than 20% of village clinics to set up traditional Chinese medicine cabinets; all township health centers (community health service centers) can provide traditional Chinese medicine rehabilitation services.
Industry events
1. CanSino, CSPC, and China Resources poured into the mRNA vaccine track
On April 3, CSPC Pharmaceutical Group issued an announcement that the company's self-developed mRNA vaccine, SYS6006, has been approved by the Food and Drug Administration to carry out clinical practice; on April 4, CanSino Bio also disclosed that it has obtained clinical approval for the mRNA vaccine under research; on April 7, Genting Xinyao and China Resources Pharmaceutical reached a cooperation to establish an independent company focusing on the discovery, development and commercialization of mRNA vaccines.
Prior to this, Fosun Pharma, Watson Biologics, Emmy Vaccine, Sigma Microbiome, etc. have carried out clinical trials of mRNA vaccines at home and abroad. In the domestic progress, Fosun Pharma and Watson Biotech have made the fastest progress, both of which have reached the phase III clinical stage and may become the first mRNA vaccine supplier approved for marketing in China.
2. Jingdong Health's top management changes
On April 7, JD Health issued an announcement that the company's directors and board committee groups had changed.
Among them, Xu Lei and Xin Lijun resigned as non-executive directors, Xu Ran resigned as non-executive directors and members of the Audit Committee and Remuneration Committee, Chen Xingyao resigned as chairman of the remuneration committee, Kim Enlin was appointed as a member of the remuneration committee, Li Ling resigned as a member of the nomination committee, and was transferred from a member of the remuneration committee to the chairman and appointed as a member of the audit committee; Wu Ying was appointed as an independent non-executive director and a member of the remuneration committee and nomination committee.
On the day of the announcement of JD Health, JD Group issued a document: Xu Lei will succeed Liu Qiangdong as the CEO of JD Group, responsible for daily operation management.
JD Health said the resignation of Xu Lei and others was mainly due to the need to spend more time and energy on other businesses.
3. Takeda Pharmaceutical China heavy production line adjustment
On April 6, it was reported that Takeda Pharmaceutical China's pantoprazole sodium enteric-coated tablets and funolas fumarate tablets will merge product lines. In this regard, Takeda Pharmaceutical China has confirmed the authenticity of the news to the media, saying that the adjustment does not involve too many personnel adjustments.
The above two drugs are drugs in the digestive field where Takeda has advantages. Among them, pantoprazole sodium enteric-coated tablets can be used to treat duodenal ulcers, gastric ulcers and moderate and severe reflux esophagitis and other diseases; the main indication of fumarate vonorasophylla tablets is reflux esophagitis.
Pantoprazole sodium enteric-coated tablets and pantoprazole sodium for injection have entered the fourth batch of collection and will be implemented in 2021, and Takeda China's products have not been selected.
4. Yihua Health or become the first stock of 2022 pharmaceutical delisting
On April 7, Yihua Health, the main medical structure operation and service and service community operation and service place, once again issued an announcement that it may be delisted risk warning, which is only half a month after the last release of the delisting risk warning
At present, Yihua Health has not yet released its 2021 annual report. However, in 2019 and 2020, the losses were 1.572 billion yuan and 625 million yuan respectively; and in its 2021 performance forecast, Yihua Health is expected to lose 360 million yuan to 540 million yuan, which has reached the brink of delisting, or will become the first stock of pharmaceuticals to be delisted in 2022.
Yihua Health started with the operation of optoelectronic products in the early days, and in 2007, it was listed on the backdoor and renamed Yihua Real Estate. In 2014, Yihua Health began a large acquisition and transformed into a big health field. Some media calculated that from 2014 to 2018, the acquisition amount of Yihua Health exceeded 3 billion yuan, but it did not bring impetus to the performance, and it was also mired in many lawsuits.
New drugs are approved
Innovent Biologics FGFR inhibitors for the treatment of cholangiocarcinoma were approved for marketing
On April 6, Innovent Biotech announced that the company's product pemetinib tablets have been approved for marketing by the Food and Drug Administration for the treatment of adult patients with advanced, metastatic or non-surgically resectable cholangiocarcinoma who have received at least one systemic treatment in the past and have been tested to have FGFR2 (Fibroblast Growth Factor Receptor 2) fusion or rearrangement. This is the first selective FGFR receptor tyrosine kinase inhibitor approved for marketing in China.
Pemitinib is a potent selective oral inhibitor of FGFR1/2/3 developed by Innovent Biologics and Incyte Corporation, which has commercial interest in China. Previously, the drug has been approved for marketing in Taiwan and Hong Kong.
2. Henlius PD-1 was granted orphan drug qualification by the FDA
On April 7, Henlius announced that the PD-1 product Slullimonumab for the treatment of small cell lung cancer has been certified by the US FDA as an orphan drug.
It is worth noting that before that, there was only one PD-L1 product from AstraZeneca in the world for the treatment of small cell lung cancer, and PD-1 products were not available. According to its 2021 annual report, the international multicentre clinical study of slullizumab for the treatment of widespread small cell lung cancer has been carried out to phase III clinical trials.
Domestically, slullimonumab was approved for marketing in March this year for advanced solid tumors in adults that have failed previous standard treatment and are not resectable or metastatic microsatellite highly unstable (MSI-H).
3. AstraZeneca obtained $350 million and platinum pharmaceutical dual antibody
On April 7, Hong Kong-listed companies and Platinum Pharma issued an announcement that HBM7022, a subsidiary of the company, has reached a cooperation with AstraZeneca, and AstraZeneca has obtained an exclusive global license for the research, development, registration, production and commercialization of the drug.
Based on this, Hebo Pharma will receive an advance payment of $25 million, a milestone payment of up to $325 million, and a royalty for HBM7022 sales. HBM7022 is an anti-tumor dual antibody against CLDN18.2 and CD3 that is currently in the preclinical phase.
4. Renfu pharmaceutical ibuprofen tablets were approved in the United States
On April 8, Renfu Pharmaceutical issued an announcement that its holding subsidiary, Yichang Renfu Pharmaceutical Co., Ltd. (hereinafter referred to as "Yichang Renfu"), received the approval number of the US FDA regarding its ibuprofen tablets, which means that Yichang Renfu has obtained the qualification to sell the drug in the United States.
According to the announcement, there are three specifications of ibuprofen tablets approved by the FDA, namely 400mg, 600mg, and 800mg; the drug is mainly used to relieve mild to moderate pain such as headache, joint pain, migraine, toothache, muscle pain, neuralgia, dysmenorrhea, and is also suitable for fever caused by the common cold or influenza.
According to IQVIA statistics, the total sales of ibuprofen tablets in the US market in 2021 will reach 88 million US dollars, and the main manufacturers are Strides, Ascend and Amneal
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