To promote the health of the whole people, the top level is continuing to work.
The long-term shortage of HPV vaccine supply in China has been noticed by the Health Commission. This week, the Health Commission made it clear that it will encourage and promote the free HPV vaccination activities for women of appropriate age in various places. On the other hand, in order to ensure the quality of medical treatment in poor areas, the Medical Administration and Medical Administration Bureau has put forward clear requirements for helping county-level hospitals.
At the same time, Omikeron is constantly disturbing the nerves of the market. As the number of new crown infection cases in various parts of the country continues to rise, the attention of new crown-related enterprises has skyrocketed. Among them, Jiuan Medical led the new crown testing sector, with an increase of 49.07% in the week, and Heatscape Biology and Oriental Biology have increased to varying degrees.
Recently, the biomedical capital market environment is grim, and many innovative pharmaceutical companies are facing a dilemma, but latecomers are still on the road. This week, the IPO applications of ADC giant Rongchang Bio and Hualan Vaccine, a subsidiary of Hualan Biologics, have been approved, and the two companies will land on the secondary market in the near future.
The Health Bureau has compiled more hot information as follows:
A list of blockbuster policies
1. The National Health Commission promotes free HPV vaccination
Recently, the National Health Commission issued an initiative to encourage qualified areas to adopt a variety of financing models to carry out free HPV vaccination activities for women of appropriate age. The Health Commission clearly stated that China will fully support the Global Strategy for Accelerating the Elimination of Cervical Cancer proposed by WHO. According to the Strategy, by 2030, 90% of girls worldwide should have completed HPV vaccination by the age of 15.
Many provinces have launched free HPV vaccination programs. Guangdong Province plans to add about 600 million yuan to the free HPV vaccine from 2022 to 2024; Lianyungang, Jiangsu Province, is vaccinating women in the eighth grade with free HPV vaccine. In addition, Jinan in Shandong, Ordos in Inner Mongolia, and Chengdu in Sichuan have also implemented corresponding policies.
The news of the free availability of hpv vaccine has changed the market supply. Previously, domestic HPV-related vaccines have been in short supply, and the price has remained high. On the 11th, Merck, the main profit maker of HPV vaccines, said that it will increase the supply of HPV vaccines in China in 2022.
2. Counterpart help, the president of the tertiary hospital needs to personally go down
On January 12, the Medical Administration Bureau of the National Health Commission issued the "Notice on Printing and Distributing the Work Plan for The Counterpart assistance of tertiary hospitals in the "14th Five-Year Plan" period" period, which clearly put forward the goal of shortening the gap between urban and rural medical service levels in 5 years:
By 2025, for counties with a permanent population of more than 50,000 people, at least one county-level hospital will reach the medical service capacity of the second-level hospital and strive to achieve the medical service capacity of the second-class hospital; for counties with a permanent population of less than 50,000 people, strive to have 1 county-level hospital reach the medical service capacity of the second-level hospital.
Among them, in the counterpart assistance, the "Notice" proposes that the tertiary hospital will send at least 5 hospital management and health professional and technical personnel to the county-level hospital (3 can be stationed in the Traditional Chinese medicine hospital), including 1 president or vice president, and each person will be stationed at the site for no less than 6 consecutive months.
3. Food and Drug Administration: Strengthen the management of radioactive drugs
On January 14, the Food and Drug Administration issued the Notice of the State Food and Drug Administration on Matters Related to Further Strengthening the Management of Radioactive Drugs, officially announcing that it will strengthen the supervision and accountability of radioactive drugs.
Among them, the inspection of three consecutive batches of samples of instantly labeled radioactive products is adjusted to be carried out after the production enterprise obtains the radiopharmaceutical production license, and can be carried out synchronously in combination with the dynamic production batch. This means increased randomness in the inspection of radioactive products.
At the same time, for drugs containing short half-life radionuclides, the Notice indicates that they can be inspected while leaving the factory. However, when an inferior product is found, the product should immediately stop production and sales, and notify the user unit to stop using it and take corresponding risk control measures.
Major events in medicine and health
1. Tigermed 2021 expected profit to rise 50%-73%
On January 12, Tigermed, the leader of clinical CRO, released its 2021 performance forecast: net profit reached 2.625 billion yuan - 3.027 billion yuan, up 50% - 73% year-on-year.
According to the announcement, the sharp increase in profitability is mainly due to the continuous rise of the company's business. At the same time, the change in non-net profit was large, and the fair value change income of the relevant company directly or indirectly invested by the company under the new financial instruments standard was 120 million yuan to 160 million yuan.
2. ADC giant Rongchang Bio is listed on the Science and Technology Innovation Board
On January 13, the Science and Technology Innovation Board announced that Rongchang Bio's registration application on the Science and Technology Innovation Board has taken effect. This means that Rongchang Bio has become a listed company in "A+H". Rongchang Biology plans to raise 4 billion yuan, which will be mainly used for the industrialization of new drugs for biological drugs, the research and development of new drugs for anti-tumor antibodies, and the research and development of new drugs for antibodies to autoimmune and ophthalmic diseases.
Rongchang Bio is the leader of domestic ADC drugs, and its development of vidisimab is the first new ADC drug approved for listing by a Chinese company, which is currently approved for the treatment of patients with gastric cancer and urinary intestinal carcinoma.
3. Hualan vaccine was approved on the GEM
On January 12, Hualan Vaccine's IPO on the Growth Enterprise Market (GEM) was approved by the CSRC. Hualan Vaccine is a subsidiary of Hualan Biologics. In April 2020, Hualan Biotech announced that it would spin off its vaccine products business and operate it separately from its subsidiary Hualan Vaccines, and promote its listing on the Growth Enterprise Market.D.
The products of Hualan Vaccine include influenza virus lysis vaccine, influenza A(H1N1) virus lysis vaccine, quadrivalent influenza virus lysis vaccine, etc.
On the GEM, Hualan Vaccine plans to raise 2.495 billion yuan, mainly for influenza vaccine development and industrialization and existing product supply guarantee capacity building projects, freeze-dried human rabies vaccine development and industrialization construction projects, multiple bacterial vaccine development and industrialization construction projects, new pneumonia vaccine development and industrialization projects, and new vaccine research and development platform construction projects.
4. The directors and senior executives of Sunshine Guojian leave their jobs
On January 12, 3Sbione Guojian issued an announcement that due to work adjustments, ZHU ZHENPING, a director, senior management and core technical personnel of the company, applied to leave the company and will not hold any position in the company after leaving. ZHU ZHENPING will join Dansheng Pharmaceutical, an incubated company owned by Sunshine.
According to the announcement, at present, Sunshine Guojian has applied for and valid 185 patent applications, and a total of 64 authorized and valid patents, of which Mr. ZHU ZHENPING has applied for and valid patent applications as a non-single inventor during his tenure of office, a total of 99 patent applications and 0 authorized and valid patents, and all the rights of the above patent applications belong to the company.
5. Fosun Pharma layout AI pharmaceuticals
On January 11, Fosun Pharma and AI pharmaceutical company Yingsi Intelligent reached a cooperation agreement to jointly develop four targets and QPCTL protein projects.
The four targets of the collaboration will be selected by Fosun Pharma, focusing on the anti-tumor field, and then evaluated and developed by Silicon Intelligence's AI platform and R&D team, and promote the preclinical phase of the drug.
In this cooperation, Fosun Pharma will pay a down payment of up to US$13 million to Ying Silicon Smart, totaling RMB82.94 million, which is the highest down payment among domestic enterprises and AI pharmaceutical companies.
6. Jiuan Medical announced that it received 8.1 billion orders from the US military
On January 14, Jiuan Medical announced that its subsidiary signed a procurement contract with the US ACC (U.S. Army Contract Management Command), and Jiuan will provide ACC with a new crown antigen self-testing agent cartridge product, with a contract amount of up to 8.1 billion yuan.
After the announcement, Jiuan Medical once again raised the limit. Since November 2021, after Jiuan Medical disclosed that its subsidiary's new crown antigen test kit obtained the sales qualification in the United States, its stock price has risen continuously, from 6 yuan to more than 75 yuan, and so far it has received more than 25 rises and stops, an increase of more than 1,000%.
On the evening of January 14, Jiuan Medical issued a supplementary announcement stating that "the US government has the right to suspend the contract at any time due to its own factors", and the US government can request the suspension of execution during the execution of the contract without reason, and cancel the subsequent procurement, and the seller needs to bear the corresponding risks and possible losses.
A week of new drug inventory
1. Hengrui Pharmaceutical TPO-R agonist opened phase III clinical trials in the United States
On January 11, Hengrui Pharmaceutical issued an announcement that the company's product HaiquPopa ethanolamine tablets have been approved by the US FDA to open Phase III clinical trials, and the indications for it are: thrombocytopenia caused by malignant tumor chemotherapy.
Hermapepiphanolamine is an oral non-peptide thromboplastin receptor (TPO-R) agonist that promotes platelet production by activating the TPO-R-mediated STAT and MAPK signal transduction pathways.
At present, herrupapethanolamine has been approved in China for the treatment of adult patients with chronic primary immune thrombocytopenia (ITP) who have not responded well to glucocorticoids, immunoglobulins and other treatments in the past, and for the treatment of adult patients with severe aplastic anemia who have poor efficacy in immunosuppressive therapy.
2. Beihai Kangcheng rare disease new drugs are proposed to be included in the priority review publicity
On January 10, according to the official website of NMPA, The Masifart oral solution of Beihai Kangcheng is proposed to be included in the priority review, and the indications for the drug are: 1 year old and older Alagille syndrome (Alageri syndrome) patients with cholestatic itching. The drug will be published from January 10 to January 17.
3. The FDA refused Toda's Alzheimer's drug to enter clinical trials
On January 12, the FDA rejected a clinical trial of Takeda's Drug DNL919 for the treatment of Alzheimer's disease, for reasons that have not yet been announced.
It is understood that DNL919 was developed by Takeda Pharmaceutical and American biopharmaceutical company Denali. The partnership was reached in January 2018, with Takeda paying Denali an upfront payment of $150 million and $8 million in reserve funding for clinical trials.
All along, the progress of Alzheimer's disease drugs has continued to attract hot discussions in the market. Since june 2021, when the FDA approved the conditional listing of Bohai's Aduhelm, the FDA's review attitude has been speculating.
Text | niacinamide
Operational | Twenty-thirteen
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![In 2021, more than 30 new drugs will be listed through priority review, and oncology drugs will still be the main line of domestic innovation[fig]](data:image/gif;base64,R0lGODlhAQABAIAAAP///wAAACwAAAAAAQABAAACAkQBADs=)