21 Jianxun Daily | this year will carry out spinal consumables collection; Genting Xinyao introduced new crown oral drugs

Source丨21st Century Business Herald

Editor 丨Xu Xu

Here is 21 Health News Daily! Welcome to pay attention to the latest events in the pharmaceutical and health industry with the new health team of 21st Century Business Herald!

Policy trends

●The National Medical Insurance Bureau revealed the collection of spinal consumables

On the 14th, the National Medical Security Work Conference was held in Beijing, which systematically reviewed the medical security work in 2021, analyzed and judged the situation of medical security reform and development, and fully deployed the medical security work in 2022. It is worth noting that the key work deployment emphasizes the need to solidly promote the "chess game" of national medical insurance, promote the national unification of the drug catalog and consumable catalog; normalize and institutionalize the collection of drugs, strive to achieve a total of more than 350 national and provincial drugs within the year, and solidly carry out the collection of high-value medical consumables in the spine; realize the pattern of all-round promotion of collection and collection of chemical drugs, biological drugs, and proprietary Chinese medicines, and further compress the sales space with gold.

●National Health Commission: The mainland's general strategy for epidemic prevention is still valid for Aomi Kerong

On the afternoon of the 15th, the joint prevention and control mechanism of the State Council held a press conference. He Qinghua, a first-level inspector of the Disease Control Bureau of the National Health Commission, introduced at the meeting that many provinces in the mainland have recently reported imported cases of the Aomi Kerong variant, and local clusters of epidemics have been reported in Tianjin and other places. Globally, the Omiljung variant has also spread in more than 150 countries and territories around the world, and has even become a major epidemic strain in some countries. As the Aumechjong variant spreads and spreads in more and more countries and regions around the world, the risk of its import into the continent through people or things is gradually increasing.

After comprehensive analysis and judgment by experts, the Aomi Kerong variant does not affect the sensitivity and specificity of the existing nucleic acid detection reagents in the mainland, and the general strategy of "external prevention of input, internal prevention of rebound" and the general policy of "dynamic clearance" of the mainland are still valid for the Aomi Kerong mutation.

Approval of pharmaceutical devices

●Jiuan Medical's POC Professional Kit for Rapid Detection of Covid-19 Antigens was approved in the United States

Jiuan Medical announced that the company learned in the early morning of January 15, Beijing time, authorized by the FDA, the company's US subsidiary iHealth USA novel coronavirus (SARS-CoV-2) antigen rapid detection POC (PointOfCare) professional version kit (colloidal gold immunochromatography method) obtained emergency use authorization (EUA), and received an authorization letter from the FDA to iHealth USA. After obtaining the U.S. EUA, the product can be used in the United States and countries that recognize the U.S. FDA EUA during the U.S. public health emergency.

●FDA approved AbbVie JAK inhibitors for the treatment of atopic dermatitis

On the 15th, the US FDA announced that it has approved AbbVie's Rinvoq (upadacitinib) to expand the indications for the treatment of moderate to severe atopic dermatitis in adults or children 12 years of age and older - these patients have not responded to previous treatments, cannot control the disease through other therapies, or should not use other therapies. This is also another JAK inhibitor approved by the FDA today for the treatment of atopic dermatitis.

capital market

●Lepu Xintai Medical Technology once again applied for an IPO in Hong Kong

According to the disclosure of the Hong Kong Stock Exchange on January 14, Lepu Xintai Medical Technology (Shanghai) Co., Ltd. submitted a listing application to the main board of the Hong Kong Stock Exchange, with CICC as the sole sponsor. It is worth noting that the company submitted a listing application to the Main Board of the Hong Kong Stock Exchange on 25 June last year, and the application is now invalid.

Founded in 1994, Lepu Xintai Medical Technology is a supplier of interventional medical devices for congenital heart disease and the largest manufacturer of congenital heart disease blocker products and related surgical supporting products in China, with a market share of 38.5% based on the revenue confirmed in 2020 sales in China.

●Maiwei Bio will land on the Science and Technology Innovation Board on the 18th

According to Maiwei Bio (688062. SH) announced its initial public offering on the Science and Technology Innovation Board, and the company's shares will be listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange on January 18, 2022.

Industry events

●Tianjin confirmed 80 new cases of local confirmed cases on the 16th

According to Healthy Tianjin, at 0-24:00 on January 16, Tianjin added 80 new confirmed cases of local new coronary pneumonia. There are no new confirmed cases of imported COVID-19 from abroad. There were no new indigenous asymptomatic infected persons, and 1 new case of asymptomatic infected person imported from abroad was added. 5 people were cured and discharged from hospital (imported cases from abroad).

From January 8, 2022 to January 16, 2022, Tianjin has reported a total of 294 confirmed cases of covid-19 in Tianjin and 294 cases in hospital. A total of 22 asymptomatic infected people have been reported, of which 14 are still under medical observation and 8 are confirmed cases.

●Genting Shin Yao introduced oral anti-coronavirus drugs

Genting Shin Yao announced that it will develop and commercialize a group of 3CL protease inhibitors at the Singapore Experimental Drug Discovery Centre globally, which is expected to become the leading oral anti-coronavirus drug in its class.

Around the new crown pneumonia, Genting ShinYao has made a wide layout, including preventive vaccines (mRNA vaccines) and therapeutic drugs. Under the agreement, Genting ShinYao received a global exclusive license from a group of 3CL protease inhibitors developed by Singapore's national drug development platform EDDC, which has also demonstrated strong in vitro activity against the new coronavirus and its variants, as well as other coronaviruses, such as the coronavirus that causes Middle East respiratory syndrome. Genting Sun Yao has a full license to further re-license the drug and will receive a complete technology transfer.

The main protease in the new coronavirus is 3CL protease, and 3CL protease inhibitors prevent the virus from replicating itself by inhibiting 3CL protease expression. Genting Xinyao said that the clinical trial evaluating EDDC-2214 is expected to start in the second half of this year. Under the agreement, Genting Sun Yao will make an advance payment of US$2.5 million, up to US$107 million for a potential development milestone and a potential sales milestone of US$15 million to US$105 million. Following the success of MERCK and Pfizer's new crown oral drugs, a number of domestic pharmaceutical companies have laid out new crown oral drugs, in addition to Genting Xinyao, ASC11 developed by Goleay and SIM0417 jointly developed by Simceree Pharmaceuticals and Shanghai Pharmaceutical Research Institute are also 3CL protease inhibitors.