-
Fuhong Hanlius LAG-3 monoclonal antibody completed the first subject administration
Time of Update: 2021-10-21
On October 12, Henlius announced that its self-developed recombinant humanized anti-LAG-3 humanized monoclonal antibody injection HLX26 for the treatment of solid tumors and lymphoma in the phase 1 clinical study is in China (excluding Hong Kong, Macao and Taiwan).
-
Tasly Compound Danshen Dripping Pills Obtained the Notice of Approval of Drug Supplementary Application
Time of Update: 2021-10-21
In 2008, the company submitted a clinical supplementary application (acceptance number: CYZB0803905) for the compound Danshen dripping pill to increase the indications of diabetic retinopathy to the Drug Evaluation Center of the State Food and Drug Administration.
-
Under the implementation of the new regulations, the ophthalmic consumables market will usher in a major reshuffle!
Time of Update: 2021-10-21
At the same time, policies are also leaning toward the industry, adding assistance to the development of the domestic ophthalmic medical device industry, and the market scale is expected to continue to expand .
-
Has invested 350 million yuan in Hengrui's topical JAK1 inhibitor phase II clinical success
Time of Update: 2021-10-21
On October 11, Hengrui Medicine announced that the double-blind, excipient-controlled, phase II/III phase II/III seamless adaptive design clinical study RSJ10431 (MARBLE23) of SHR0302 alkali ointment for the treatment of atopic dermatitis developed by its subsidiary Ruishi Biotechnology Among them, the 0.
-
China Medical City has entered the stage of industrialization, and three more pharmaceutical companies have been approved for drug production licenses
Time of Update: 2021-10-21
The author has learned that recently, three more companies in China Medical City have successively obtained drug production licenses issued by the Jiangsu Provincial Drug Administration, and have officially entered the stage of industrialization .
-
Mengke Pharmaceutical is selected as the 2020 Shanghai High-tech Enterprise Cultivation List
Time of Update: 2021-10-21
"Being selected into the 2020 Shanghai High-tech Enterprise Storage Cultivation List marks that Mengke Pharmaceutical's scientific research and innovation capabilities have once again been recognized by the authority .
-
Leading domestic pharmaceutical equipment industry, performance is expected to usher in a period of continuous growth
Time of Update: 2021-10-21
. The industry predicts that in the context of the favorable pharmaceutical environment, the continuous optimization of the pharmaceutical competition pattern and the continuous increase of market concentration, the profitability of pharmaceutical equipment companies will gradually increase in the future .
-
"Seeing the leopard in a tube", how is the boom in the three quarterly reports of the pharmaceutical equipment industry?
Time of Update: 2021-10-21
In addition to Tofflon, many pharmaceutical equipment companies have also announced the three quarterly report appointment disclosure dates.
Many domestic pharmaceutical companies have accelerated their internationalization strategy this year, and overseas business is expected to usher in a new round of growth .
-
Directors, deputy general managers...The wave of resignations of senior executives of listed pharmaceutical companies continues!
Time of Update: 2021-10-21
Kangyuan Pharmaceutical: Director resigns On October 11, Kangyuan Pharmaceutical announced that the company’s board of directors recently received a resignation report from Director, Deputy General Manager, Board Secretary and Chief Financial Officer Yin Honggang.
-
Within one month, nearly 500 institutions intensively investigated this medical device company
Time of Update: 2021-10-21
According to Wind data, in the first three quarters of 2021, 2,506 A-share companies have disclosed their investor relations activity records, a significant increase of more than 1,000 over the same period of the previous year .
-
Corium Donepezil transdermal patch Adlarity new drug application is expected to be approved next year
Time of Update: 2021-10-21
On October 12, 2021, Corium announced that the US FDA has set the new drug application (NDA) PDUFA target date for its donepezil (donepezil) transdermal patch Adlarity to March 11, 2022 for the treatment of mild/medium/ Patients with dementia caused by severe Alzheimer's disease .
-
Under the license in fever, pharmaceutical companies must avoid "false innovations"
Time of Update: 2021-10-21
At present, for companies, the industry believes that they still need to continuously improve the level of innovation and focus on the clinical value of drugs in order to move towards a good future .
-
Shanxi Province Chinese Medicine Formula Granule Management Implementation Rules (Draft for Solicitation of Comments) Released
Time of Update: 2021-10-21
Manufacturers that carry out production filing or sales filing shall submit relevant filing materials through the "Chinese Medicine Formula Granule Recording Management Module of the Pharmaceutical Business Application System of the State Drug Administration" (hereinafter referred to as the formula granule filing module) in accordance with the procedures and requirements .
-
FDA grants AstraZeneca Tezepelumab orphan drug certification for the treatment of EoE
Time of Update: 2021-10-21
In addition, in the subgroup of patients with a baseline eosinophil count of <300 cells/μl, the trial also reached the primary endpoint: compared with placebo+SoC, tezepelumab+SoC treatment made AAER statistically significant and Decrease of clinical significance .
-
FDA blockbuster drug approval plan in October 2021
Time of Update: 2021-10-21
CompilenewbornAs of September this year, the US FDA has approved a total of 40 innovative drugs, compared with 40 in the same period last year and 53 in the whole year of last year .
Entering October, a number of drugs will usher in an important review decision by the FDA .
-
The impact of new crown oral drugs against the epidemic and vaccines
Time of Update: 2021-10-21
On October 1, Merck announced the interim analysis data of its new crown oral specific drug molnupiravir (monupivir) in the mild phase III MOVe-OUT study.
-
The Pharmacopoeia Commission publicizes draft national standards for 14 varieties of chemical drugs
Time of Update: 2021-10-21
cnMailing address: Office of the National Pharmacopoeia Commission, Building 11, Fahua South Lane, Dongcheng District, BeijingPost Code: 100061National Pharmacopoeia CommitteeOctober 09, 2021Attachment: Salbutamol Sulfate Orally Disintegrating Tablets-Publication Draft.
-
ALK-1 monoclonal antibody/Opdivo combination for first-line treatment of advanced liver cancer is clinically approved in China
Time of Update: 2021-10-21
Pioneer Pharmaceuticals announced that the National Medical Products Administration (NMPA) of China has recently approved its ALK-1 monoclonal antibody (GT90001C), and Bristol-Myers Squibb's (BMS) anti-PD-1 monoclonal antibody nivolumab (English trade name Opdivo) Combined clinical trial for the treatment of patients with advanced hepatocellular carcinoma (HCC) who have not been systemically treated .
-
September Pharmaceutical Events: Corporate Issues: Frequent Major Actions such as Investment and Acquisitions of Listed Companies
Time of Update: 2021-10-21
Jilin Aodong announced on the evening of September 13 that the company has recently received the "Notice of Share Increase Plan" from the controlling shareholder Jincheng Company .
-
Eli Lilly's CDK4/6 inhibitor receives FDA approval for the first time to treat early-stage breast cancer
Time of Update: 2021-10-20
Patients with cancer cells and other high-risk characteristics found in the lymph nodes are more likely to relapse, and they need innovative therapies to prevent the recurrence of the disease .
Reference materials:[1] FDA Approves Verzenio® (abemaciclib) as the First and Only CDK4/6 Inhibitor for Certain People with HR+ HER2- High Risk Early Breast Cancer.
