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19 new Class 1 drugs were added this week, and 6 clinical trials in the field of domestic oncology drugs were approved

 Last Update: 2021-12-24
 Source: Internet
 Author: User

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(People's Daily Health Client Li Xuanzhang) As of December 11, 2021, data from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration shows that a total of 5,980 clinical trial applications have passed "implicit permission

As of December 11, 2021, data from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration show that a total of 5,980 clinical trial applications have passed "implicit permission

Wei Li Zhibo: Malignant tumors are approved, and the combination with anti-PD-1 antibody has further synergistic effect

According to the public information of Wei Li Zhibo, the clinical research indication approved for its LBL-019 injection is malignant tumor

Kaixin Yuanda: Non-Hodgkin's Lymphoma clinical research approved

Kaixin Yuanda introduced BI-1206 from BioInvent International.

Simcere Pharmaceuticals: Glioblastoma clinical research approved

Simcere's introduction of Paxalisib capsules from Kazia Therapeutics was approved this time to carry out Phase 2/3 clinical studies for newly diagnosed and recurrent glioblastoma

In March of this year, Simcere and Kazia Therapeutics reached a cooperation of over US$290 million to introduce the development and commercialization rights of the product in all indications in the Greater China region

Borui Pharmaceuticals: Approved for advanced malignant solid tumors, original targeted polymer conjugated drugs

The clinical research indication approved by Borui Medicine for injection BGC0228 is advanced malignant solid tumor

According to public information, Borui Medicine originally designed a targeted polymer coupling drug based on the concept of ADC, replacing the antibody with a polymer target, and forming a new compound through the peptide chain combined with traditional cytotoxic drugs, achieving precise connection without falling off , The molecular weight is smaller than ADC drugs, which can smoothly penetrate tumor cells and release drugs into tumor cell tissues to achieve the purpose of killing tumors

Zhengxiang Medicine: Approved for advanced solid tumors, relapsed/refractory hematological malignancies

The ZX-101A capsule of Zhengxiang Medicine has obtained four clinical trials implied permission in China this time, and its indications are advanced solid tumors and relapsed/refractory hematological malignancies

It is reported that ZX-101A is a new generation of PI3Kδ/γ dual-target inhibitor with a significantly improved safety window.

Simcere Pharmaceuticals: Phase 1 clinical study approved for advanced solid tumors and skin T-cell lymphoma

The SIM1811-03 injection of Simcere Pharmaceuticals approved this time is a phase 1 clinical study for the treatment of advanced solid tumors and skin T-cell lymphoma

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