Good news! Overseas clinical experiment data sharing and special procurement policies help promote the price reduction of oral drugs and anticancer drugs; Huahai actively tests carcinogenic impurities, and wants to push NDMA into the quality standard of valsartan?

This week's news is that the leading group of deepening medical reform of the State Council made a major adjustment: on July 12, the general office of the State Council issued the notice on adjusting the members of the leading group of deepening medical and health system reform of the State Council (GBF [2018] No 56) After the list was adjusted, sun Chunlan, vice premier of the State Council, served as the group leader, he Lifeng, director of the development and Reform Commission, Ma Xiaowei, director of the health and Health Commission, Liu Kun, Minister of the Ministry of finance, Zhang Jinan, Minister of human resources and social security, Ding Xiangyang, Deputy Secretary General of the State Council, and Hu Jinglin, director of the medical insurance bureau served as the Deputy group leaders Compared with the past, the Deputy group leader's members include the director of the state health insurance bureau Good! The overseas clinical trial data can be shared On July 10, when the imported drugs or the price will be greatly reduced, the State Food and Drug Administration officially issued the technical guidelines for accepting the overseas clinical trial data of drugs (hereinafter referred to as the guidelines) The guiding principles make clear the application scope, basic principles, integrity requirements, technical requirements and acceptance degree of overseas clinical trial data, aiming to provide referential technical specifications for overseas clinical trial data to be used in drug registration applications in China, so as to encourage simultaneous research and development of drugs at home and abroad, accelerate clinical urgent need, and ensure efficacy The drugs with controllable safety risk are on the market in our country, which can better meet the drug demand of patients in our country In response, some experts commented that the policy reduced the cost of money and time for clinical trials This policy is much more important than zero tariff Within 4 months, special procurement must be completed quickly! Recently, a notice on carrying out provincial-level special centralized procurement of anticancer drugs (Draft for comments) has begun to circulate in the industry It is reported that the notice has the following requirements for the time of price reduction of anticancer drugs: 1 Each province shall issue a special procurement plan for anticancer drugs by the end of August this year; 2 By the end of September, the special procurement work shall be fully started; 3 By the end of this year, the special procurement work shall be completed The price of Internet, purchase, clinical use and terminal are all in place, benefiting patients According to this rhythm, it is required to complete the plan formulation, centralized procurement implementation, promotion, implementation and transmission to the terminal within four months Market Alert: Huahai actively tests carcinogenic impurities, and wants to push NDMA into the quality standard of valsartan? On July 5, the European Drug Administration (EMA) issued a notice: due to the detection of impurities, EMA is evaluating the drugs of valsartan APIs produced in Huahai, Zhejiang Province, and some valsartan drugs are being recalled in the European Union The detected impurity is nitrosodimethylamine (NDMA), which belongs to class 2A carcinogen in the list of carcinogens published by the International Cancer Research Institute of the World Health Organization on October 27, 2017 It is reported that the sales volume of valsartan in Europe in 2017 was 328 million yuan On July 7, Huahai released the announcement of Zhejiang Huahai Pharmaceutical Co., Ltd on finding extremely trace genotoxic impurities in the unknown impurities of valsartan API, saying that in the process of optimizing the production process of valsartan API, under the unknown impurities, the company found and verified that one of the unknown impurities was nitrosodimethylamine (NDMA) According to the investigation, the impurity is the inherent impurity produced by valsartan production process, the content is very small, and the same production process used in the employment has common characteristics, and the impurity contains genotoxicity On July 9, Huahai released the relevant progress announcement, saying that after the EMA released the recall announcement, the drug regulatory departments of Germany, Italy, Finland, Austria, Japan and other countries successively released the recall announcement At 3 p.m that day, Huahai shares fell 9.99% In this event, some insiders concluded that Huahai's verification of NDMA impurities in valsartan was active and deliberate The purpose of this action is to make NDMA be included in the quality standard of valsartan, so that suppliers who are not capable of research and verification will withdraw first and the market will be reshuffled FDA warning letter: Recently, the FDA issued a warning letter about Zhuhai federal Pharmaceutical Co., Ltd because its production, processing, packaging or preservation methods, facilities or control measures do not conform to cGMP, the company's products are identified as adulterated Another six enterprises have received GMP certificates This week, the State Food and Drug Administration reported the follow-up inspection results of six companies, namely Guilin ZHONGZU traditional Chinese Medicine Co., Ltd., Tonghua Xinghua Pharmaceutical Co., Ltd., Yangling Biomedical Technology Co., Ltd., Xi'an Zili traditional Chinese medicine group, Jilin tianqiang Pharmaceutical Co., Ltd of Diaoyutai Pharmaceutical Group and Jilin Guoyao Pharmaceutical Co., Ltd., and ordered the counterpart food and drug administration to take back the relevant GMP certificates of the enterprises Enterprise Hot 100 years of pharmaceutical enterprise innovation! On July 11, Pfizer released a new round of news release The company's business will be reorganized into three parts: innovative drug business (including Bio similar drugs and hospital business department focusing on anti infection and sterile injection products), mature drug business and health drug (OTC) business The restructuring will take effect in fy2019 There are one big one and one small two major changes in the adjustment: previously, the health business belonging to the innovative medicine business was singled out Pfizer said that it would evaluate the strategic choice of the business and make a decision within this year; in the innovative business sector, a new hospital business department was singled out Pfizer said that the purpose was to focus on the important role of the hospital in the medical system Yuheng Pharmaceutical Co., Ltd plans to purchase Tianmai bio with an annual revenue of only 1.44 million yuan on July 10 Yuheng Pharmaceutical Co., Ltd announced that it is expected to purchase no less than 35% of Tianmai bio's equity with no less than 4 billion yuan in order to obtain control over Tianmai bio According to the main financial data of Tianmai biology, as of December 31, 2017, the total assets and net assets of Tianmai biology were 1.49 billion yuan and 1.46 billion yuan respectively By 2017, Tianmai biology had realized an operating revenue of 1.4449 million yuan It is reported that Tianmai biology has been committed to the research and development of insulin and insulin like drugs Its technology comes from BTG company in Israel BTG, Novo Nordisk, Lilly and Sanofi call it the "four families" in the field of insulin Moreover, Tianmai has established a recombinant human insulin production platform with independent intellectual property rights, and has created seven major products of the second and third generation of insulin, 27 product specifications A series of insulin injection and oral capsule product chain has become the third biopharmaceutical enterprise in the whole industrial line after Tonghua Dongbao and Ganli The pre IPO round financing value of tiansili bio reached 12.5 billion yuan recently Tiansili bio, an innovative biopharmaceutical enterprise with the heavyweight listed product "puyouke" in cardio cerebrovascular field and the richest R & D pipeline in the industry, announced the completion of the pre IPO round financing Its post investment value will reach 12.5 billion yuan (about 1.9 billion US dollars) The financing is led by Hong Kong Huiqiao capital, followed by France's merrier group and famous Chinese institutions, with a financing line of about 1 billion yuan (close to 150 million US dollars) Recently, Arnold Pharmaceutical Co., Ltd won the global exclusive right to develop and sell buparlisib, a cancer drug Recently, Arnold Pharmaceutical Co., Ltd announced to sign a global license agreement with Novartis in Hangzhou to obtain the global exclusive right to develop, produce and sell buparlisib (bkm120, an2025), a cancer treatment drug of Novartis, by means of down payment, milestone payment, etc Buparlisib is an oral panpi3k inhibitor with the function of tumor immunity (I / O) It has shown clinical activity in solid tumor and blood cancer patients The global phase II clinical trial of paclitaxel combined with buparlisib in the treatment of head and neck squamous cell carcinoma has been completed, and the drug safety is manageable It has obtained the fast track qualification of FDA Content source: China Medicine News, yiou.com, e-medicine manager, dandelion, etc