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⊙ Hisco: BTK protein inhibitors approved for clinical trials in the United States
⊙ Roche: Reached an innovative strategic cooperation with Teva Pharmaceuticals
⊙ Sanofi: Dupridomab is approved as a new indication in the European Union
⊙ Xinlitai: HFpEF drug SAL007 clinical trial application was accepted
⊙ Rongchang Biologics: RC98 for injection of PD-L1 monoclonal antibody was approved for clinical trial
HiSco: BTK protein inhibitors are approved for clinical trials in the United States
On April 15, #HiSco announced that its BTK protein inhibitor HSK29116 U.S. Clinical Trial Application (IND) was approved by the FDA. This clinical trial is to evaluate the safety, tolerability and pharmacokinetics/pharmacodynamics of the drug in subjects of relapsed or refractory B-cell malignancies.
According to the announcement, HSK29116 is an oral PROTAC small molecule anti-tumor drug independently developed by HiSco that targets BTK, which is used for the treatment of relapsed refractory B-cell lymphoma, and is the first BTK-PROTAC drug in China and the second in the world to enter clinical research. This variety has been approved by the State Drug Administration (NMPA) for clinical trials in April 2021, and clinical dose climbing trials in China and Australia are rapidly advancing, and have been carried out to the fourth dose group, and are making good progress. U.S. clinical trials will be an important part of HSK29116's global multicenter study and will soon officially launch Phase I clinical trials.
Roche: Reached an innovative strategic cooperation with Teva Pharmaceuticals
On April 18, #Roche Pharma announced that it has reached a cooperation agreement with Teva Pharmaceutical Co., Ltd. (hereinafter referred to as "Teva"), a well-known Pharmaceutical company in Israel, to integrate their respective superior resources to further expand the original research of bendamustine hydrochloride - Cunda ® in China patients accessible.
Cunda ® is Teva's self-developed original research and development of bendamustine hydrochloride, approved in China in 2018, is Teva's original research product for the treatment of inert B-cell non-Hodgkin lymphoma (NHL) that progresses during or after treatment with rituximab or rituximab regimens.
Sanofi: Dupridomab is approved as a new indication in the European Union
On April 19, #Sanofi issued a press release saying that the European Commission (EC) has expanded the marketing authorization of dabituto (dupridomab) in the European Union, approving it for additional maintenance regimens for patients aged 6 to 11 years who are poorly controlled with type 2 inflammatory severe asthma after treatment with medium and high doses of inhaled glucocorticoids (ICS) in combination with another maintenance drug. According to the Sanofi press release, dupridomab is the only biological agent approved by the European Union for use with type 2 inflammatory severe asthma.
Xinlitai: HFpEF drug SAL007 clinical trial application was accepted
On April 19, #Xinlitai announced that its clinical trial application for recombinant human neuromodulatory protein 1-anti-HER3 antibody fusion protein injection (domestic project code: SAL007) was accepted. The company's application is a Phase I clinical trial application for HFpEF (heart failure with ejection fraction retention) indication for sal007 chronic heart failure.
SAL007 (US project code: JK07, hereinafter referred to as "07") is a NRG-1 (neuromodulatory protein-1) fusion antibody drug independently developed by Salubris Bio in the United States and has global intellectual property rights, and the proposed development indication is chronic heart failure.
It is reported that the product is the first Sino-US dual-report innovative biological drug of Xinlitai, which was approved by the US FDA for clinical trials in February 2020 and by the Chinese CDE in September 2020. Currently, Salubris Bio in the United States is enrolling in the second dose group of the HFrEF (Heart Failure with Reduced Ejection Fraction) Phase I clinical trial, which is expected to be completed in the near future, and is preparing for the start-up of the HFpEF clinical trial. China is conducting Phase I clinical trials of HFrEF.
Rongchang Biologics: RC98 for injection of PD-L1 monoclonal antibody was approved for clinical trial
According to the official website of CDE, the injection RC98 of #Rongchang Bio has recently been approved for clinical treatment of HER2 expression gastric cancer.
Screenshot source: CDE official website
It is understood that RC98 is a PD-L1 monoclonal antibody. Previously approved for clinical use as a solid tumor, it is currently under Phase I/IIa clinical study.
Screenshot source: Yaorongyun China Clinical Trial Database
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