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Enpagliflozin has been approved by the European Union for the treatment of heart failure and has submitted a regulatory application in China
Time of Update: 2021-08-09
On June 21, 2021, Boehringer Ingelheim and Eli Lilly and Company jointly announced that the European Commission has approved the expansion of their SGLT2 inhibitor empagliflozin (empagliflozin, English trade name Jardiance) It is used to treat patients with chronic heart failure with reduced ejection fraction (with or without type 2 diabetes) .
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Targeting CCR4 "Moglizumab" submits a listing application in China
Time of Update: 2021-08-09
Public information shows that mogamulizumab is a CCR4 targeting antibody that has been approved by the FDA for breakthrough therapy and priority review, and has been approved for marketing in the United States for the treatment of mycosis fungoides ( MF) or Sezari syndrome (SS) in adult patients .
Retrieved August 8, 2018, from https:// -announces-fda-approval-of-poteligeo-mogamulizumab-kpkc-for-the-treatment-of-mycosis-fungoides-and-sezary-syndrome-300694118.
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Submitted a domestic market application for nascentumumab in children with high-risk neuroblastoma
Time of Update: 2021-08-08
Naxitumumab is a relapsed/refractory high-risk neuroblastoma treatment drug developed by Y-mabs.
cn/v5/home/)With the two GD2 antibodies of Detuximab and Naxitumumab submitted for NDA in China, it is believed that patients with high-risk neuroblastoma will usher in new treatment options and obtain longer survival benefits .
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Cinda Biologics FGFR inhibitor pemigatinib tablets submitted for marketing
Time of Update: 2021-08-07
The listing application of pemigatinib in China is based on a case of unresectable locally advanced, recurrent or metastatic cholangiocarcinoma subjects who have failed at least first-line systemic treatment in the past, accompanied by FGFR2 fusion or rearrangement, and unresectable.
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The long-term efficacy of DMD therapy has been actively submitted to China for regulatory applications
Time of Update: 2021-08-07
On July 1, 2021, NS Pharma, a subsidiary of Nippon Shinyaku, announced that its antisense oligonucleotide therapy Viltepso (viltolarsen) is in a phase 2 clinical trial for the treatment of patients with Duchenne muscular dystrophy (DMD) Shows positive long-term effects .
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Organic arsenic anti-cancer therapy submits new drug application for treatment of lymphoma in Japan
Time of Update: 2021-08-06
On June 30, 2021, Solasia Pharma of Japan announced that it has submitted a New Drug Application (NDA) for its research drug darinaparsin to the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of relapsed/refractory peripheral T-cell lymphoma ( PTCL) .
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China Plastics Association submitted an application to the Development and Reform Commission to investigate abnormal fluctuations in TDI prices
Time of Update: 2021-08-06
Due to the recent large fluctuations in the price of TDI, the China Plastics Processing Industry Association submitted an application to the National Development and Reform Commission to investigate abnormal fluctuations in TDI prices.
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Tianguangshi Biologics submitted an IPO application on the Hong Kong Stock Exchange, and the third
Time of Update: 2021-08-05
In addition, Tianguangshi Biotechnology has submitted a phase 1 clinical trial application of MIL97 in China in May 2021, with a view to treating metastatic pancreatic cancer and other solid tumors .
MIL95: An anti-CD47 antibody jointly developed by Tianguangshi Biology and Connoa Biology is currently undergoing phase 1 clinical trials in China .
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Nuocheng Jianhua SHP2 allosteric inhibitor submits clinical application
Time of Update: 2021-08-05
According to the press release, ICP-189 is mainly used to treat a variety of solid tumors.
It aims to provide new solid tumors such as lung cancer, head and neck cancer and gastrointestinal tumors Clinical treatment methods .
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Luye Pharma's next-generation VMAT2 inhibitor submits clinical trial application in the U.S.
Time of Update: 2021-08-04
On August 2, Luye Pharmaceutical Group announced that its self-developed new generation of vesicle monoamine transporter 2 (VMAT2) inhibitor LY03015 has submitted a clinical trial application in the United States and will soon enter the phase I clinical phase .
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Concord Kirin mogamulizumab monoclonal antibody submitted a marketing application in China for skin T-cell lymphoma
Time of Update: 2021-08-02
1 months), and the overall response rate increased to 28% (vs 5%)Based on the results of this research, the FDA launched mogamulizumab in August 2018 to treat adult patients with relapsed or refractory mycosis fungoides or Sezari syndrome who have received at least one systemic therapy .
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The focus of retail pharmacy inspections is to submit a self-inspection report before the end of November
Time of Update: 2021-07-24
Each county bureau is responsible for formulating the annual supervision and inspection plan at the same level; organizes thesupervision and inspection of the quality and safety ofpharmaceutical equipment in the area of the drug retail enterprises, medical device business enterprises, medical institutions, drug and medical device network sales enterprises, disease prevention and control institutions, and inoculation units; organization; Carry out training for relevant pharmaceutical equipment circulation supervisors and enterprise (unit) quality management personnel .
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WeDoctor officially submits IPO prospectus, revenue of 1.8 billion yuan in 2020
Time of Update: 2021-07-12
Digital medical service platform WeDoctor Holdings formally submitted a listing application to the main board of the Hong Kong Stock Exchange on the evening of April 1 .
In 2020, medical service revenue is 706 million yuan, accounting for 38.
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WeDoctor submits prospectus, net loss exceeds 1.9 billion in 2020
Time of Update: 2021-07-12
According to Frost & Sullivan data quoted in the prospectus, based on the number of Internet hospitals by the end of 2020 and the number of digital diagnosis and treatment provided in 2019, WeDoctor is China’s largest digital medical service platform.
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BIOVAXYS submits relevant applications and materials to the FDA
Time of Update: 2021-07-12
For immune response diagnostic products, the US Food and Drug Administration (FDA) submitted an IND (Investigative New Drug) pre-meeting application and submitted a briefing package to its Center for Evaluation and Research of Biological Products (CBER) .