Read Now: Qilu Pharmaceutical Files Application for Anti-PD-1 Monoclonal Antibody to Go Public

September 22 | Issue 3

Qilu Pharmaceutical Files Application for Anti-PD-1 Monoclonal Antibody to Go Public

China—September 17, 2023, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced on its official website that Qilu Pharmaceutical's application for the marketing approval of Category 1 new drug, Iparomlimab Injection, has been accepted. According to publicly available information from Qilu Pharmaceutical, this is a PD-1 targeting IgG4 antibody being developed for the treatment of various types of cancer.

FORWARD PHARMA initiates Phase 1 clinical trial of third-generation oral SERD for breast cancer!

China—September 15, 2023, Shenzhen FORWARD PHARMA announced that it has successfully completed the administration of the first subject in the Phase 1 clinical study of its proprietary third-generation oral selective estrogen receptor degrader (SERD), FWD1802, in patients with ER+/HER2-unresectable locally advanced or metastatic breast cancer. FWD1802 has been approved for clinical trials in the U.S. and China.

Akeso, Inc. PD-1/CD73 Dual Antibody Approved for Clinical Use

China—September 8, 2023, The official website of the China National Medical Products Administration (CDE) announced that Akeso, Inc.'s Class 1 new drug AK131 injection has been approved for clinical use. This drug will be used in the treatment of advanced solid tumors. Publicly available information shows that AK131 is a dual-specificity antibody targeting PD-1 and CD73, developed independently by Akeso, Inc.

4th！ADC targeting HER2 of Hengrui Pharmaceuticals to be included in breakthrough therapeutic class

China—September 5, 2023, CDE official website announced that SHR-A1811 for injection declared by Hengrui Pharmaceuticals is to be included in the breakthrough therapeutic varieties, targeting the indication of HER2-positive advanced colorectal cancer. Public information shows that SHR-A1811 is a HER2-targeted antibody-coupled drug (ADC), which has been included in the breakthrough therapeutic varieties three times.

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