"Pharmaceutical Express" Measatan potassium tablets will be approved for listing Pfizer somatro...

January 8, 2021 / Medical Information List: Health and Wellness Commission informs infants to use antibacterial creams to make large dolls; Pfizer DMD gene therapy completes phase 3 clinical trials of the first patient administration; Roche Tiragolumab is eligible for breakthrough drugs ... Daily fresh medicine news, speed reading society and you pay attention to! Part1 Policy Brief Beijing January 7 1 new local confirmed cases January 7 from 0:00 to 24:00, Beijing added 1 new locally confirmed cases, no new suspected cases and asymptomatic infections;
a man, 27 years old, now lives in The village of Xi Zhaozhuang in the town of Beishige, Shunyi District.
December 28, 2020 as a close contact of confirmed cases of centralized isolation medical observation, January 6, 2021 nucleic acid test results were positive, from 120 negative pressure ambulances transferred to ditan hospital, comprehensive epidemiological history, clinical manifestations, laboratory testing and imaging examination results, January 7 was diagnosed as a confirmed case, clinical type is common.
(Beijing Municipal Health Commission) Hebei on January 7 added 33 locally confirmed cases 39 cases of local asymptomatic infection January 7, 2021 0-24 hours, Hebei Province added 33 new cases of local new coronavirus pneumonia confirmed cases, of which Shijiazhuang City reported 31 cases (1 case of asymptomatic infected persons into confirmed cases), Yantai City reported 2 cases (1 case of asymptomatic infection into confirmed cases).
no new deaths and no new suspected cases.
(Hebei Provincial Health Commission) 2 pharmaceutical enterprises expired without renewing the certificate was cancelled "drug production license" recently, Guizhou Provincial Drug Administration issued a notice that Guizhou Guandexing Baozhilin Pharmaceutical Co., Ltd., Guizhou Ruicheng Pharmaceutical Co., Ltd. 2 enterprises due to the expiration of the "drug production license" expired without re-licensing, in violation of the "Drug Production Supervision and Management Measures" Article 20, it was cancelled.
(Guizhou Provincial Drug Administration) because of the visible foreign body 1 drug enterprises were fined 1.82 million January 6, Guizhou Provincial Drug Administration issued administrative punishment case information 39th issue said, Guizhou Jingfeng Injection Co., Ltd. ginseng glucose injection due to the inspection of visible foreign objects "detected obvious foreign objects", so the results did not meet the requirements, was fined a total of 1.82 million.
(Guizhou Provincial Drug Administration) Health Committee informed infants with anti-bacterial cream into a big doll: ordered the recall of the products involved on January 8, there are people reflect the Fujian Ouai Baby Health Care Products Co. , Ltd. production of "Eveling multi-effect special anti-bacterial cream" suspected of illegal addition of "hormones" and other issues.
the information, Zhangzhou City Health Commission Joint Market Supervision Bureau quickly stepped in, immediately organized personnel to the enterprises involved in the scene of investigation.
the enterprises involved have suspended production and notified dealers of all related products off the shelves.
incident is under further investigation.
(Zhangzhou City Health Committee) Part3 production by observation of coronary biology: the full-year net profit is expected to be 45 million-50 million yuan turned a profit on January 8, Crown Bio announced that the full-year net profit is expected to be 45 million-50 million yuan, a loss of 465 million yuan in the same period last year.
The company's biomass sector will continue to grow steadily in 2020, and in 2020 the company's pharmaceutical product BenVimod cream will enter the national health insurance catalog for the first time, which will greatly improve the accessability of the drug, but also conducive to the product's marketing and future sales, the company's operating performance will have a positive impact.
(Crown Bio-Announcement) and Yu pharmaceutical completed the $123 million D-round financing on January 8, and Yu-Pharma announced that it had recently completed a $123 million D-round financing.
round of financing is led by Carlyle Investment Group, Huaping Investment, Obo Capital, Qingchi Capital and a well-known investment institution in Boston.
the completion of the current round of financing, the cumulative financing amount of Heyu Pharmaceuticals reached 263 million U.S. dollars.
the funds raised will be used to further accelerate the development and rapid progress of its four clinical projects and multiple preclinical projects.
(Pharmaceutical Mission) Co-Vietnam Pharmaceuticals received $53.5 million in B-plus Phase 1 financing on January 7, and Co-Vietnam Pharmaceuticals, which is committed to developing a new generation of complementary targeted drugs, announced a $53.5 million B-plus Phase 1 financing.
the current fund is jointly provided by life sciences venture capital funds such as RA Capital, Viking Capital, Foresite Capital and Squine Bay Capital, with existing investors Quancheng Capital and Qiming Ventures participating.
, according to a press release, Cotco Pharmaceuticals plans to roll out three complementary targeted therapies to the clinic over the next 18 months.
(Pharmaceutical Mission) Part3 drug news GSK AIDS new drug Dotiravelpivelin tablets domestic newspaper listing January 8, CDE official website shows that GSK / ViiV imported new drug Dotera Velpivellin tablets market application was accepted.
the drug is a new HI-2 compound medicine.
this newspaper listed Dotiravelpivelin tablet is a two-in-one HIV compound new drug, composed of dotirave and lipivellin in 50mg/25mg specifications.
(Insight Database) Takeda Class 1 new drug Meshatan potassium tablets will soon be approved for listing recently, Takeda Pharmaceuticals according to class 5.1 declared Measatan potassium tablets listing application is in the "approval" stage, is expected to be approved by NMPA in the near future.
used to treat primary hypertension.
methadan potassium is a hemangiotensin II blocker developed by Takeda, an oral pre-drug that can be rapidly metabolized by esterase into the active ingredient Azishatan during the absorption process.
(Pharmaceutical Rubik's Cube Info) Hengrui Pharmaceutical tymphetamine softgel was approved on January 7, NMPA's latest batch shows that Hengrui Pharmaceutical 4 classes of generic drug dohamine softgels were approved for listing and as if through consistent evaluation, becoming the second domestic approval.
the drug is a prostate hyperplation treatment.
is a 5-alpha-reductase inhibitor that inhibits both type I. and type II 5 alpha reductase, which is used to treat moderate and severe symptoms of benign prostate hyperplus.
(Insight database) a mahoca: hydrochloric acid bromoso injections by the drug registration certificate January 8, a mastick announcement, recently received the State Drug Administration approved the issuance of the hydrochloric acid bromoso injection "drug registration certificate."
company developed hydrochloric acid bromoline injection adaptation: suitable for acute and chronic lung diseases accompanied by abnormal sputum secretion and poor sputum function.
(a mammonary announcement) is day clear TQC3721 declared clinical for chronic pulmonary and asthma January 8, CDE official website shows that is day sunny 1 class of new drug inhalation with TQC3721 mixed suspension clinical application was accepted.
the drug is a new class 1 drug for chronic pulmonary resistance and asthma.
TQC3721, which is currently clinically declared, has not disclosed any other information other than adaptation.
another new drug, TQC3564, was approved for clinical use in 2019Q3, and 2020 Q3 completed Phase 1 clinical, which has not yet been initiated.
(Insight Database) Hengrui Pharmaceuticals apple acid famini capsules obtained drug clinical trial approval on January 8, Hengrui Pharmaceuticals announced that recently received approval from the State Drug Administration issued on the appleic acid famini capsules and SHR-1701 injection of the "Drug Clinical Trial Approval Notice", and will be conducted in the near future clinical trials.
the company's innovatively developed small molecule multi-target tyrosine kinase inhibitor.
SHR-1701 can promote the active effect of T cells, but also can effectively improve the tumor micro-environment immune regulation, and ultimately effectively promote the immune system for tumor cells.
can be combined or not combined for the treatment of advanced or metastasis non-small cell lung cancer in Phase II clinical studies.
(Henrui Pharmaceutical Bulletin) and platinum medicine CTLA-4 monoantigen HBM4003 initiated a Phase I clinical January 7, Insight database showed, and Platinum Pharma CTLA-4 monoantigen HBM4003 initiated a Phase I clinical for advanced solid tumors.
previously, on December 28, 2020, a clinical trial of HBM4003 in association with PD-1 monoantigen Ripley monoantigen for advanced/metastasis melanoma was just launched.
HBM4003 is an all-human anti-CTLA-4 heavy chain antibody produced from the Harbour Mice platform unique to platinum medicine, and platinum took 3 years to advance it from the drug candidate screening phase to the clinical stage.
(Insight Database) Pfizer DMD Gene Therapy completed phase 3 clinical trials of the first patients to be drugged January 8, Pfizer announced that its treatment of DMD in the study of gene therapy PF-06939926 completed phase 3 clinical trials of the first patients.
phase 3 clinical trial, called CIFFREO, is expected to include 99 non-bedding male patients aged 4-7 in 55 clinical trial centers in 15 countries.
DMD is a rare genetic disease caused by mutations in genes that encode antimyostrophy proteins on the X chromosome.
Pf-06939926, developed by Pfizer, is an intravenous gene therapy.
it will be controlled by human muscle-specific initiation of the "mini" anti-muscular atrophy protein genetically modified in the adeno-related virus 9 vector.
clinical trial is an important milestone for this patient group.
(Xinhua) -- Pfizer's new drug for childhood growth hormone deficiency, somatrogon, entered for review on January 7, Pfizer and OPKO Health announced that the FDA has accepted a biopharmaceon's license application for somatrogon, a long-acting human growth hormone that is used once a week to treat pediatric patients with growth hormone deficiency.
FDA has designated a target date for the Prescription Drug User Charge Act as October 2021.
(Bio Valley) Roche tiragolumab breakthrough drug qualification Roche recently announced that the FDA has awarded TIGIT target new cancer immunotherapy tiragolumab breakthrough drug qualification, combined with anti-PD-L1 therapy Tecentriq, for first-line treatment of tumors with PD-L1 high expression, no EGFR or ALK genome tumor distortion metastasis non-small cell lung cancer patients.
(Bio Valley) Alnylam subsultural injection RNAi therapy Phase 3 clinical trial results positive January 8, Alnylam Pharmaceuticals announced that it is in the study of RNAi therapy vutrisiran, in the treatment of genetic thyroxine protein amyloid degeneration patients in Phase 3 clinical trials reached the main endpoint and two secondary endpoints after nine months.
the company plans to submit a new drug application to the FDA earlier this year, which, if approved, would be The fourth RNAi treatment approved by Alnylam.
(Pharmaceutical Mingkangde) Hengrui "fluorine palladium" new adaptive diseases to be priority review January 8, according to the CDE official website priority review publicity, Hengrui Pharmaceutical PARP inhibitor fluorine Pali new adaptation listing applications to be included in the priority review review approval, for platinum-sensitive relapsed epitheliotic ovary cancer, fallopian tube cancer or primary peritoneal cancer in platinum-containing chemotherapy to achieve complete or partial remission of maintenance treatment.
(Insight Database) the first sub-cortical injection PD-L1! Corning Jerry / Idea Dean Worley Single Anti-Trump Priority Review January 8, according to the CDE Priority Review Column announced that Sichuan Idea Dikangrui Pharmaceuticals' Nwolly Single Anti-Injection Application is to be included in the priority review approval, the formulation of adaptation for microsatellite highly unstable advanced colorectal cancer and MSI-H advanced gastric cancer and DNA mismatch repair function of the entity.
(Insight Database) - The treatment of head and neck cancer in the UK was rejected on January 7th, according to a draft guideline published, after reviewing new evidence, NICE issued recommendations that nivolumab should not be recommended for the treatment of adult patients with relapsed or metastatic head and neck squamous cell carcinoma during or after platinum chemotherapy, citing a lack of long-term survival and quality of life data.
is still under discussion on the draft recommendations issued on 7 January, after which the NICE Review Committee will meet again to make a final recommendation.
(Sina Medical News)