"Pharmaceutical Express" and platinum pharmaceutical HKEx IPO application for the latest version of the new coronary treatment program released.

August 19, 2020 / Medical Information List: Gilead JAK inhibitor filgotinib rejected by the FDA; AstraZenecon PD-L1 inhibitor eligible for FDA priority review; over $1 billion! Lilly receives exclusive license from Xinda Bio PD-1 to fight outside China, and Takeda Japan's local sales executives will retire early... Daily fresh medicine news, speed reading society and you pay attention to! Part 1 Policy Brief just now! The latest version of the new coronary diagnosis and treatment program issued by the National Health and Health Commission issued "on the issuance of a new coronavirus pneumonia diagnosis and treatment program (trial eighth edition) notice."
According to the plan, the new crown pneumonia belongs to the category of Chinese medicine "epidemic" disease, the disease because of the feeling of "epidemic" gas, according to the disease, local climate characteristics and different physical conditions, reference to the program for dialectical treatment.
involving ultra-pharmacopeia doses should be used under the guidance of a physician.
(National Health and Wellness Commission) August 18, 17 new confirmed cases are overseas imported cases August 18 0-24 hours, 31 provinces (autonomous regions, municipalities directly under the Central Government) and Xinjiang Production and Construction Corps reported 17 new confirmed cases, are overseas imported cases (Shanghai 8 cases, Guangdong 4 cases, Zhejiang 2 cases, Shaanxi 2 cases, Shandong 1 case);
(National Health Care Administration) FDA: No disclosure of clinical trial results will be subject to fines The FDA recently announced guidelines for civil fines for reporting violations in clinical trial databases, which can be as high as $100,000 per day.
in accordance with relevant federal regulations, those responsible for registering clinical trials on the official website of ClinicalTrials.gov should accurately and completely disclose the results of relevant clinical trials.
(FDA) 10 provincial supplies negotiations: only 6 domestic products won the bid recently, Shaanxi Province Public Resources Trading Center issued "on the inter-provincial alliance of public medical institutions artificial crystal cross-regional joint belt volume procurement bargaining results."
total volume of procurement of 168,987, the proposed selection involves 56 products, of which 6 products for domestic products to be selected, 50 products for imported products to be selected.
(Public Resources Trading Center, Shaanxi Province) Part 2 Has observed the departure of Geelyde China General Manager Luo Yongqing According to media reports, Gilead's global business operations officer Johanna Mercier announced in an internal company email that the global vice president, China General Manager Mr. Rogers Luo decided to leave Gilead to seek external development.
his last working day in Gilead was September 10.
(Sina Pharmaceutical News) Takeda Japan's local sales executives will retire early Takeda announced on the 18th, will provide Japanese employees with "early retirement" services.
under the age of 30 who have worked at the company for at least three years can apply for separation between September 28 and October 16, with a target departure date set for November 30.
who leave early will receive severance pay and support for finding a new job.
is understood that the so-called "future career plan" will be aimed at sales and administration, not the research and development or manufacturing business units.
(Sina Pharmaceutical News) and Platinum Pharma filed for IPO on the Hong Kong Stock Exchange on the 18th, and Platinum Pharmaceuticals filed an IPO application on the Hong Kong Stock Exchange, co-sponsors Morgan Stanley, BofA Securities and CITIC Securities.
, and Platinum Pharma applied for listing on the Main Board of the Stock Exchange under Chapter 18A of the Listing Rules.
fund raising will be used in part for the clinical development of three pillar products: FcRn inhibitors, TNF-alpha inhibitors and anti-CTLA-4 antibodies.
(Medical Mission) more than $1 billion! Lilly received exclusive license from Xinda BioPD-1 Monoantigen outside China Xinda Bio and Lilly Pharmaceuticals on the 18th jointly announced that the two sides will expand the immune tumor drug anti-PD-1 monoclonal antibody Daboshu (Xindili monoanti) strategic cooperation, the new cooperation will expand to the global market.
the agreement, Lilly will receive exclusive licenses from Xindilli's mono-resistance outside China, and Thysta Bio will receive a cumulative total of more than $1 billion.
(Pharmaceutical Mission) Dijon Pharmaceuticals completed a $100 million round of A-round financing Dijon Pharmaceuticals recently completed a $100 million A-round financing, led by Lilly Asia Fund, Sequoia Capital, Tsany Innovation and Wuxi City two levels of government funds involved.
(Pharmaceutical Mission) well-known pharmaceutical company chairman, general manager resigned recently, Sichuan Fuzheng Pharmaceutical Co., Ltd. announced the resignation of the chairman and general manager, said that on August 10, the company's board of directors received the resignation report submitted by chairman Sun Jilin, effective August 10, 2020.
same day, Sun Jilin also resigned as general manager of Sichuan Fuzheng Pharmaceutical Co., Ltd., effective August 10.
resigned, he will no longer hold other positions in the pharmaceutical industry.
(Auxiliary Pharmaceuticals Announcement) Part 3 Drug News Gilead JAK inhibitor filgotinib was rejected by the FDA before Gilead oral JAK inhibitor filgotinib was rejected by the FDA.
Gilead said the FDA has issued a full response to a new drug application for filgotinib to treat moderate to severe active rheumatoid arthritis, saying the agency wants more data from two other clinical studies, MANTA and MANTA-RAy.
(Sina Pharmaceutical News) AstraZeneia PD-L1 inhibitors have been approved by the FDA for priority review qualification AstraZenecon announced that its application for a license for complementary biological products for Valeant monomatics has been accepted by the FDA and has been granted priority review eligibility.
degree valiyu monoantigen is an anthologized PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80, thereby blocking tumor immune escape and releasing the suppressed immune response.
(Pharmaceutical Mingkangde) 6 generic drugs through consistent evaluation from Zhengda Tianqing, Stone Pharmaceutical Group... The official website of the State Drug Administration on the 18th showed that there are 6 generic drugs through the consistent evaluation, including Nanjing Zhengtian Qing's Ruishuvastatin calcium tablets, Xianhe Pharmaceuticals' Montaigne (15th), Changao Pharmaceuticals' calcium hydroxybenzene tablets (first), Akihito Pharmaceuticals' Losolofen sodium tablets (2nd) and Shi pharmaceutical group's kramycin tablets (5th) and Gremeta dispersal tablets (first).
(National Drug Administration) East Sunshine 2 diabetes compound preparations were approved for the first time 18, Dongshuangon 3 new class 4 diabetes products (Liglitatin metformin tablets, siglitatin tablets and siglitatin tablets) were approved by the State Drug Administration for listing.
, Liglitatin metformin tablets and siglitin metformin tablets for the domestic first imitation, phosphoric acid segritin tablets for the domestic second.
(Pharmaceutical Rubik's Cube) the first new 4 categories of "iodized kesha alcohol injection" was approved for market recently, Steyri new 4 classes of generic drug iodized kesha alcohol injection was approved by the State Drug Administration listed, as well as through the consistent evaluation, as the first domestic manufacturer of this variety through consistent evaluation.
(Pharmaceutical Rubik's Cube) Colum Pharmaceuticals injection with yew alcohol (albumin binding type) was approved for market on the 18th, Colum Pharmaceuticals submitted 4 classes of generic drug injection with yew alcohol (albumin binding type) approved by the State Drug Administration listed, as consistent evaluation.
albumin yew alcohol, developed by Abraxis, is a new preparation that combines yew alcohol with albumin, overcomes the shortcomings of poor water solubility, low efficiency and side effects of ordinary yew alcohol, and was approved by the FDA in January 2005 to treat breast cancer, and was subsequently approved for the treatment of lung and pancreatic cancer.
(Pharmaceutical Rubik's Cube) Colum's compound amino acids (16AA-II.)/glucose (48%) Electrolyte injections approved By Colum Pharmaceuticals announced that the company's Class 3 generic compound amino acids (16AA-II.)/Glucose (48%) electrolyte injection was approved by the State Drug Administration for listing, the first in China, before the original research manufacturer Belang's Nutriflex special (70/240).
(Colum Pharmaceuticals Announcement) Monty Pharma Pratsa was approved in recent days, The market application for "Pratsa Injection" (acceptance number JXHS1800080) in the status of NMPA changed to "in-approval", which means that the treatment of recurring or incurable external T-cell lymphoma drug is about to be approved in China.
(CPhI Pharmaceuticals Online) Beijing Ted 1 new drug by CDE to accept Ted Pharmaceuticals independently developed a new class of new drug TDI01 submitted AND application and CDE acceptance. It is understood that the variety in January this year has submitted an IND application to the U.S. FDA, and was approved, has now started Phase I clinical administration trials.
(Insight Database)