First PD-L1 McAb in mainland China approved for listing in Qiming medical market

[December 10, 2019 / list of medical information] the national drug use monitoring platform was put into operation; 45 drugs in Wuhan entered the first batch of low-cost purchase catalogue; Qiming medical was listed today; bendamostine, a Zhengda Tianqing drug, was approved to be listed Daily fresh medicine news, speed reading club and you pay attention to! Statistics and information center of the health care Commission yesterday announced that the national drug use monitoring platform has been put into operation At present, 8840 medical and health institutions have completed the system login, with an average daily visit of 600000 people The launch of the "national drug use monitoring platform" is to accurately grasp the use of drugs in all levels of public medical and health institutions, and promote the priority use of essential drugs (health and Health Committee) Recently, the official website of the health care Commission released the industry standard of medical device safety management The classification and risk of medical devices are divided in detail According to the relevant national laws and regulations, the standard preparation group studies and analyzes the actual situation of the safety management of medical devices used in clinical practice in China, summarizes the practical experience, and formulates the standard on the basis of widely soliciting the opinions of all parties (health and Health Committee) On September 9, the joint procurement office of Wuhan pharmaceutical and Machinery Co., Ltd issued the detailed rules for the implementation of the first batch of drugs in 2019 in Wuhan and the first batch of drugs in 2019 in Wuhan 45 drugs were released into the first batch of procurement catalogue This catalogue is determined in the drugs purchased by the state and Hubei Province, and the range of varieties selected is the drugs and class II psychotropic drugs that are online in the "Hubei provincial centralized procurement service platform for medical devices" and have transaction volume in medical institutions in Wuhan area before June 30, 2019 (Wuhan pharmaceutical machinery joint procurement office) Tianjin Medical Insurance Bureau has recently issued the notice of municipal human resources and Social Security Bureau of Tianjin Medical Insurance Bureau on docking the work of National Drug Catalogue in 2019 Recently, Hubei Provincial Food and Drug Administration issued the notice on regulating the supervision and management of business license of drug retail chain enterprises (Draft for comments) "Notice" clearly points out: newly established drug retail chain enterprises must have more than 10 subordinate Direct stores in the province that have been accepted and issued by the local municipal and County Market Supervision Bureau (Tianjin Medical Insurance Bureau) Recently, Sichuan Administration of traditional Chinese Medicine issued a news that the regulations on traditional Chinese medicine of Sichuan Province (Revised) came into force on December 1, 2019 After the National Congress of traditional Chinese medicine, Sichuan became the first province to introduce local regulations of traditional Chinese medicine and put them into effect In the future, there will be more places to issue TCM policies in line with the new situation, and TCM groups will have great potential at the grass-roots level (Sichuan Administration of traditional Chinese Medicine) Today, Qiming medical was officially listed on the Hong Kong Stock Exchange under the securities code of 02500.hk The IPO price is HK $33 / share, with a total of 78537500 shares issued The opening price is HK $39 / share, with a market value of HK $15.7 billion as of the issuance So far, Qiming medical has become the first unprofitable medical device enterprise listed according to the new Hong Kong stock standard (shell Society) Yesterday, MSD and arqule jointly announced that they have reached an acquisition agreement, and MSD will purchase all the publicly issued shares of arqule at a price of $20 per share through its subsidiaries, with a total amount of about $2.7 billion Arqule has a competitive new oral and reversible Btk inhibitor ARQ 531 in its research products At present, arqule is developing B-cell malignant tumor, which is in phase II MSD used the acquisition to expand its cancer pipeline (medicine cube) On September 9, Sanofi announced that it would purchase all outstanding shares of synthorx at a price of US $68 per share, with a total amount of US $2.5 billion Sanofi took this opportunity to acquire the pipeline for strengthening its tumor immunity products, which was 172% higher than synthorx's closing price on Friday Thor-707, synthorx's main immunooncology product, is an improved version of IL-2 It is currently being used as a single substance or in combination with immunosuppressive checkpoint inhibitors to treat a variety of solid tumors (medicine cube) Zhaoderivative officially signed a contract on December 4 to complete round a financing of US $60 million This financing is led by Huagai capital, with the participation of nest capital, Hong Kong Hualian holdings, Xiangtang capital and other institutions The funds will be mainly used for the production capacity construction of zhaoderivative in the scale of 100000 liters in Beijing base of China and the business development of China and the United States (arterial network) Recently, Yuanji Huayi announced the completion of round a financing, which is led by Huaxing capital group and Tencent After obtaining the financing, Yuanji Huayi will continue to work in the field of new drugs and new technology R & D incubation in the future Founded in August 2018, jihuayi is a new drug incubation and R & D platform focusing on supporting the whole process of original drugs in the field of nervous system from laboratory research and development, preclinical research, clinical process design to clinical trials (medical Valley) Today, a new anti-cancer pioneer named zentalis pharmaceuticals stepped out of the hidden mode and obtained US $85 million in financing Since its establishment in 2014, the company has raised US $147 million in development funds In five years, three anti-cancer candidate drugs have entered the clinical development stage (chuangjianhui) The FDA updated the processing status (acceptance No.: jxss1800040 / 41) of AstraZeneca PD-L1 monoclonal antibody imfinzi (durvalumab), and changed it to "approval completed - to be prepared" Imfinzi was approved for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) which has not progressed after concurrent radiotherapy and chemotherapy This is the sixth immunocheckpoint preparation listed in China and the first PD-L1 monoclonal antibody listed in mainland China (Sina Medical News) A new class 3 generic drug, bendamostine (acceptance No.: cyhs1600193), was approved for use in the treatment of non Hodgkin's lymphoma Wednesday, the official website of the State Drug Administration showed (Insight database) On October 10, the third generation EGFR-TKI "efutinib" independently developed by Ellis bio was accepted by the drug Audit Center (acceptance No.: cxhs1900039), becoming the third generation EGFR-TKI in China (Insight database) On October 10, xinlitai announced that the company and its subsidiaries, xinlitai biotechnology and xinlitai pharmaceutical declared the "recombinant all human anti PCSK9 monoclonal antibody injection" obtained the implicit permission of clinical trials from the State Drug Administration, and will carry out clinical trials in the near future At present, only iloximab has been approved for import in China, and the product is expected to become the pioneer of PCSK9 inhibitor in China (meter net) Roche pharmaceutical China announced today that China's State Food and drug administration has officially approved the first-line standard treatment plan of pajite ® (patozumab), Herceptin ® (trastuzumab) and docetaxel for HER2 positive metastatic breast cancer patients who have not received anti HER2 treatment or chemotherapy (American news agency) According to the new drug development monitoring database, CDE plans to include the Amgen bispecific antibody blincyto in the priority review Bilintomolobib is a bite molecule developed by Amgen based on its dual specificity T cell adapter platform and targeting at CD19 and CD3 at the same time It is also the first dual specificity antibody approved by FDA on the company's bite technology platform (Medical Geography) Regen announced at ash annual meeting that its bispecific antibody, regn5458, targeting BCMA and CD3, has obtained positive experimental data in 1 / 2 phase clinical trials of patients with relapsed / refractory multiple myeloma Regn5458 is a kind of bispecific antibody developed by regenerant based on its velocimmune and velocibi technology platforms, which can target BCMA and CD3 Veloclmune is a new generation of transgenic mouse platform with human B cell immune system, which can produce optimized all human antibodies (yaomingkant) Blue medicine announced its oral kit and avapritinib, an inhibitor of PDGFR α, at the annual meeting of ash, and obtained excellent preliminary clinical data in the phase 2 trial pioneer for the treatment of patients with inert systemic mastocytosis The serum tryptase level of patients in different dose groups of avapritinib decreased significantly and rapidly (yaomingkant) The U.S federal government has launched a program called "ready, set, prep", which will provide free pre exposure HIV prevention drugs truvada and descent of Gilead company for 200000 HIV high-risk groups who do not receive Medicaid, the Department of Veterans' health management or any other federal health program Meanwhile, the federal government will pay Gilead about $200 per bottle (medical Valley) Recently, scientists from Fudan University and other institutions found that a new engineering peptide-ibp-cp24 may be expected to be a long-term anti HIV drug, which can be used alone or with a wide range of neutralizing antibodies to treat and prevent HIV-1 infection Ibp-cp24 can show a long half-life, but also can potentially carry anti HIV-1 activity, even for drug-resistant strains (Biovalley)