Research and development daily Fosun Pharma First-in-class new drug approved clinically by the FDA.

2020.10.21 Research and Development NEWS: Two Phase 3 clinical trials of Merca East V114 were positive; NMDA subject regulator PTSD showed early therapy; The second indication of Aegean lunvatinib was about to be approved; johnson CD38 single-resistance two listing applications were to be included in the priority review; Hengrundasheng's first CD19/CD22 dual-target CAR-T declaration was accepted... We focus on the latest developments in pharmaceutical research and development, to provide research and development personnel with timely and accurate information reference.
(click on the title, read the original article) "Drug Research and Development" Merca East V114 two Phase 3 clinical trial results positive Mercadon Corporation announced today, in the study of 15-price streptococcus pneumoniae vaccine V114, in two phase 3 clinical trials called PNEU-PATH (V114-016) and PNEU DAY (V114-017).
Kexing New Corona Inactivated Vaccine obtained positive mid-term safety data in Phase 3 clinical trials, the Butantan Institute in Brazil announced that the new CoronaVac, developed by Beijing Kexing Zhongwei Biotechnology Co., Ltd. in collaboration with a number of partners, showed good safety data in the mid-term analysis of Phase 3 clinical trials.
NMDA regulator PTSD shows early efficacy U.S. biotech company Aptinyx announces that its NMDA regulator NYX-783 has shown some efficacy in a post-traumatic stress disorder (PTSD) phase II clinical trial.
Drug Approval: Fosun Pharma First-in-class new drug was approved by the FDA clinical 20, Fosun Pharma announced that its controlling subsidiary Orinove Inc. small molecule innovation drug ORIN1001 tablets were approved by the FDA for clinical trials for iditable pulmonary fibrosis, and is scheduled to be launched in the United States in the near future phase Ib clinical trial of the allergic.
Xinlitai "Dapositin hydrochloride tablets" will be approved on the 18th, Xinlitai declared the four classes of generic drug dapositin tablets market applications into the "in the approval" stage, is expected to be approved in the near future.
Wesser Lunvatini 2nd adaptive disease is about to be approved recently, Japan's Aegean Lunvatini 2nd adaptive disease listing application changed to "in the approval", is expected to be approved for the near future listing, for the treatment of differentiated thyroid cancer.
Kanghong hydrochloric acid zuminapulent release capsule clinical trial was approved by NMPA today, Chengdu Kanghong Pharmaceuticals announced that the company received the State Drug Administration issued on the hydrochloric acid zuminapulent release capsule "drug clinical trial approval notice."
notice showed that the hydrochloric acid zuminaplun slow-release capsule met the requirements for drug registration and agreed to conduct human bioethic equivalent trials and validated clinical trials for depression.
Hengrun Dasheng's first CD19/CD22 dual-target CAR-T declaration was accepted on the 20th, Shanghai Hengrun Dasheng Biotech Co., Ltd.'s first CD19-CD22 dual-target CAR-T drug clinical trial application was accepted by NMPA.
, Hengrun Dasheng has received a total of 3 CAR-T clinical approvals, targeting CD19 and BCMA.
Yiming Anko VEGF/PD-L1 dual specific antibody clinical application was accepted by CDE 21, CDE latest publicity, Yiming Anke Class 1 bio-new drug injection IM2510 clinical application was accepted.
is a dual-specific antibody that can target both VEGF and PD-L1 and is intended to be developed for use in solid tumors.
this is the first time the product has been declared clinical in China, yiming Anke after the IMM01 project and IMM0306 project, the third project to submit clinical applications.
Johnson and Johnson CD38 single-anti-ion two listing applications to be included in the priority review 21, CDE website latest publicity, Johnson and Johnson's Yangsen company developed CD38 monoclonal antibody Daleitoyu single-anti-injection two listing applications were included in the proposed priority review varieties.
The results of clinical trials published in Cells: The prevention of respiratory infections is also used in the latest issue of Cells, the results of a clinical trial show that card-mediated seedlings can also benefit the elderly with low immunity, safe and effective prevention of a variety of respiratory infections.
based on the results, the researchers hope to use larger studies to assess the protection against new coronavirus infections.
Hengrui Pharmaceutical PD-1 antibody combined with Apatini for cervical cancer single-arm Phase 2 results Recently, JOC online published a study of advanced cervical cancer single-arm Phase 2 results, the experimental product is Hengrui Pharmaceutical PD-1 antibody Karelliju single anti-combined small molecule target drug apatini.
results showed that the objective remission rate (ORR) of second-line therapy for advanced cervical cancer reached 55.6% and the medium progression-free survival (PFS) was 8.8 months.
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