Roche PD-L1, a pharmaceutical speed reading agency, has won the termination of 260 million collaborations between four clinical drug companies in China

September 8, 2020 / Medical Information At a Glance: Bayer Adempas for the clinical success of PAH patients with insufficient response through PDE5i treatment; Daily fresh medicine news, speed reading society and you pay attention to! Part 1 Policy Brief Vaccine Regulatory Quality Management System Internal Audit Summary Meeting held recently, the State Drug Administration held a summary meeting on the quality management system of vaccine supervision, summarized the vaccine supervision quality management system internal audit, the deployment of the next stage of vaccine supervision quality management system construction.
fully recognize the results of the internal audit process.
stressed that the operation and maintenance of the vaccine regulatory quality management system is a long-term dynamic process that needs to be sustained.
also proposed that quality management should be integrated into the actual work of vaccine supervision, through the effective operation of the quality management system, to promote the implementation of regulatory compliance.
(State Drug Administration) State Health Insurance Bureau issued a national inspection of the price of supplies 7, the State Health Insurance Administration issued a "medical security administrative law enforcement matters guidance directory", requiring the price of drugs, medical supplies monitoring and cost investigation.
also requires that drug market license holders, pharmaceutical and medical supplies production enterprises, pharmaceutical operating enterprises and medical institutions to provide the competent departments of pharmaceutical prices with information on the actual purchase and sale price of their medicines, medical supplies and the quantity purchased and sold.
, there will also be supervision and inspection of the compliance of centralized procurement of pharmaceuticals and high-value medical supplies in public medical institutions.
(National Health Insurance Administration) Drug Administration of the latest notice of pharmaceutical enterprises before the start of self-examination, Jiangxi Provincial Drug Administration issued "on the implementation of the 2020 pharmaceutical preparation production enterprises adverse reactions report and monitoring and inspection work notice."
notification requirements, pharmaceutical preparation production enterprises in strict accordance with the announcement and the General Administration on the issuance of adverse drug reaction reports and monitoring and inspection guidelines (trial) and other documents, from September 4 to September 16 to carry out a serious self-examination work.
(Jiangxi Provincial Drug Administration) Part 2 after observation of 260 million two well-known pharmaceutical companies to terminate cooperation 7, Haisco issued a notice, wholly-owned subsidiary Sichuan Haisco on September 4 and Haitron Pharmaceuticals signed a "patent implementation license agreement and related agreements to terminate the agreement."
After friendly consultations between the two sides, Sichuan Haisco transferred the original HC-1119 patented products to Haitron Pharmaceuticals, with a total transfer value of RMB260 million, to be paid in three installments.
(Cypress Blue) Yanyuan Pharma introduced two clinical stage tumor-targeted drugs from the first three days of 7th, Yanyuan Pharma through its subsidiary Anhet Pharma and the first three signed a license agreement to introduce two clinical stage tumor field candidate innovative drugs.
the first three codes of these two innovative drugs are DS-1001 and DS-1205, respectively, ab-218 and AB-329.
under the license agreement, the first three can receive advances, milestone payments for development, registration and commercialization, and royalties for net post-market sales.
(Immediate Drug News) 350 million yuan to obtain the rights and interests of microbial vaccines, Tibet Pharmaceuticals invested another 340 million yuan to build a production line On June 15, Tibet Pharmaceuticals paid the new crown vaccine products, tuberculosis vaccines and influenza vaccine products to sri s microorganisms cooperatively, and invested 351 million yuan in microbials in stages to obtain the exclusive rights to develop, register, produce, use and commercialize the above-mentioned products worldwide.
Tibet Pharmaceuticals announced today that in order to meet the needs of future vaccine production, the company intends to purchase from Shanghai Lingang Huaping, located in Shanghai, China, Fengxian Park Lingang Zhiyuan Phase 6 real estate production line construction.
total amount of housing and land is estimated to be about $340 million.
(Sina Pharmaceutical News) Oncocross completed about $14 million in round B financing recently, Oncocross announced that most local investment institutions in South Korea, such as SM-Sino Technology Investment, GNtech VC, Smilegate Investment, have successfully received about $14 million in round B financing.
this round of financing will be used primarily for the introduction of a competitive new drug, Pipeline, through Bioventure/Pharmaceutical Enterprise technology, as well as for clinical trials of existing Pipeline and the recruitment of the industry's best manpower.
(Pharmaceutical Rubik's Cube) ACTG announced the completion of the latest round of equity financing ACTG announced the completion of the latest round of equity financing, the amount of which was not announced, aflac Ventures LLC and Kyoto University Innovation Capital for this round of leading investors.
(Xinhua) -- Part 3 Drug News Bayer Adempas for the clinical success of phase IV in patients with insufficient response by PDE5i, Bayer announced the positive results of phase IV study REPLACE at the 2020 Virtual Annual Meeting of the European Respiratory Society.
In this study, moderate-risk pulmonary hypertension (PAH) adult patients switched to Adempas treatment after insufficient response to treatment with phosphate dylase-5 inhibitors (PDE5i), with specific data showing that 41% of patients transitioning to Adempas treatment achieved clinical improvement without clinical deterioration, compared with 20% of patients in the PDE5i treatment group who achieved clinical improvement, and the study reached a composite primary endpoint.
(Sina Pharmaceutical News) Novartis high dose Enerzair Breezhaler significantly reduced the acute onset rate of moderate to severe asthma, Novartis announced that in medium or high doses of long-acting beta-2-subject agonists/inhaled corticosteroids can control asthma patients, a large daily dose of Enerzair Breezhaler combination compared to a daily moderate dose, can significantly reduce moderate or severe acute asthma attack rate.
(Sina Pharmaceutical News) is a biologically similar drug start phase III clinical recently, is a big day to start patoju single anti-injection (TQB2440 injection) phase III clinical evaluation TQB 2440 Multi-center, randomized double-blind, parallel control Phase III clinical studies of the effectiveness and safety of early or local late ER/PR-negative HER2-positive breast cancer patients treated with injections/part of the pyrethroid monotherapy.
clinical trial program to recruit 412 patients in the country.
(Insight database) Roche PD-L1 inhibitors in China won 4 clinical CDEs latest publicity, Roche PD-L1 inhibitor Tecentriq (Atili Pearl monoanti) was approved again 4 clinical, the proposed development of adaptations are: Atili Pearl monoantigen combined tiragolumab, for the platinum-containing program after chemotherapy did not progress in the local late, non-removable stage III small cell lung Patients; Atili pearl monoantigen anti-combination beval bead monoanti, used in non-excisible liver cell carcinoma patients after catheter hepatic artery chemotherapy embolism treatment; atili pearl monoanti-anti-combination low-dose radiotherapy, cisplatin/carptonin, etoposide, treatment of wide-term small cell lung cancer; and atili-pearl monoantigen and beva bead monoantigen monoantigen for the treatment of untreated, broad-term small cell lung cancer patients.
(CDE) Henrui Pharmaceuticals apple acid famini capsules approved to carry out clinical trials Hengrui Pharmaceuticals announced that the company and subsidiary Shanghai Hengrui Pharmaceutical Co., Ltd. apple acid famini capsules recently received the Approval Notice for Drug Clinical Trials approved by the State Drug Administration, and will soon start clinical trials.
the company's innovatively developed small molecule multi-target tyrosine kinase inhibitor.
(Hengrui Pharmaceutical Announcement) re-ding medicine 190 million U.S. dollars to introduce anti-cancer drugs approved five clinical CDE latest publicity, and then Ding pharmaceutical declared REGN1979 injection was approved five clinical implied license, the adaptive disorder is "the past systemic treatment after recurrence or difficult treatment of B-cell non-Hodgkin lymphoma patients."
REGN1979 is a CD20xCD3 dual-specific antibody developed by Regenerative Yuan, and in April this year, Reding Pharmaceuticals acquired the development and exclusive commercialization interest of the drug candidate in Greater China for US$190 million.
(CDE) antipsychotic drug fluorosterol tablets first through the consistency evaluation 7, the State Drug Administration website shows that Ningbo Red Eagle Pharmaceuticals fluorosterol tablets supplement application was approved, for the first variety through the consistency evaluation.
fluorosterol belongs to the classic first generation of antipsychotic drugs, in the control of the fierce, but also to control hallucinations, delusions and other positive mental symptoms.
the current domestic approved dosage forms have ordinary tablets and injections, in addition to Ningbo Red Eagle Pharmaceuticals, there is no enterprise through the consistent evaluation.
(National Drug Administration)