Recent developments in new drug research in China, two major anticancer drugs have entered the clinic

Recent developments in new drug research in China, two major anticancer drugs have entered the clinic

January 08, 2018 Source: WuXi PharmaTech

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1. Livzon Group's heavy new drug proton pump inhibitors are expected to be approved in the near future

On January 2, Livzon Group announced that the status of registration application for the production of ilaprazole sodium and praprazole sodium for injection was changed to “approval-to-certification”, meaning heavy-duty varieties for injection. Prazole is expected to be approved in the near future! Apraprazole is a new class of 1.1 drugs independently developed by the company. It belongs to the new generation of proton pump inhibitors (PPI) and has won the second prize of National Science and Technology Progress Award. Peptic ulcer is a common disease of the digestive system, and proton pump inhibitor is the drug of choice for the treatment of peptic ulcer.

2. Zhongsheng Pharmaceutical Innovative Medicine ZSP0391 obtained clinical approval for the treatment of non-small cell lung cancer

On December 25, 2017, Guangdong Zhongsheng Pharmaceutical Co., Ltd. (hereinafter referred to as Zhongsheng Pharmaceutical Co., Ltd.) announced that CFDA has formally approved the ZSP0391 clinical trial application. ZSP0391 is an innovative non-small cell lung cancer drug for the treatment of EGFR-sensitive mutations and T790M-resistant mutations. The mechanism of action is clear and clinically proven. The possibility of clinical transformation is extremely high, and it has the potential to become a Best-In-Class drug. The future launch of ZSP0391 will fill the domestic gap of the third generation of EGFR inhibitors, providing patients with low-cost, safe and efficient therapeutic drugs. The same drug that has been marketed in China is AstraZeneca's Ochinib (trade name: Teresa).

3. The new PI3K inhibitor CYH33 of the Chinese Academy of Sciences has obtained clinical approval for the treatment of various solid tumors.

Recently, the anti-tumor class 1 new drug CYH33 jointly developed by the Ding Jian research group of the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, the Yang Chunyu research group, the Meng Linghua research group and Shanghai Haihe Pharmaceutical Research and Development Co., Ltd. obtained the clinical trial approval issued by the CFDA. CYH33 is a highly selective inhibitor of phosphoinositide 3-kinase a (PI3Ka). PI3Ka gene amplification or mutation is highly activated in various solid tumors and has become one of the important targets for tumor molecular targeted therapy. It is said that only two PI3Ka selective inhibitors have entered the clinical research in the world, showing good application prospects. There is currently no such drug in clinical research in China. The team also found that the receptor tyrosine kinase expression profile in breast cancer cells is expected to be a biomarker for predicting efficacy, providing a basis for patient selection in CYH33 clinical trials.

4. Olin biorecombinant Staphylococcus aureus vaccine obtained the conclusion of phase 1a clinical trial

On January 2, Olin Bio (833577) announced that the company had received a summary report on the phase Ia clinical trial of recombinant Staphylococcus aureus vaccine (Escherichia coli) issued by the Jiangsu Provincial Center for Disease Control and Prevention. The main conclusions are as follows: The safety of the vaccine is clinically acceptable, the vaccine is immunogenic, and specific humoral and cellular immune responses are rapidly produced on day 7 of vaccination and peak on days 14-21. Recombinant Staphylococcus aureus vaccine (Escherichia coli) is a national class 1 new drug. It was jointly developed by Olin Bio and the Third Military Medical University of the People's Liberation Army. On June 18, 2015, the drug was approved for clinical trials. In May 2016, it was officially launched. Phase clinical trials.

Reference materials:

[1] Company announcements

[2] Official website of Shanghai Institute of Materia Medica, Chinese Academy of Sciences

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