Three new anti-tumor drugs are planned to be included in breakthrough treatment varieties

Text|Pharmaceutical Mission Hills

According to the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China, three new anti-tumor drugs are planned to be included in breakthrough treatment products, which come from Haihe Pharmaceutical, Hutchison Medicine, and Five Prime Therapeutics under Amgen

1.

Indications: Specific locally advanced or metastatic non-small cell lung cancer

Gumatinib (SCC244 project) is an oral potent and highly selective c-MET inhibitor, which inhibits the phosphorylation process by binding to the c-MET receptor at the ATP binding site, thereby inhibiting c-MET intracellular tyrosine The activation of amino acid kinase blocks the downstream cascade from the upstream of the signaling pathway

Public information shows that Haihe Pharmaceuticals is currently carrying out multiple clinical trials of glutmetinib in China, the United States, and Japan at the same time

2.

Indications: Specific relapsed/refractory follicular lymphoma

HMPL-689 is a research and highly selective small molecule PI3Kδ inhibitor.

At the 2020 American Society of Hematology (ASH) online annual meeting, the preliminary analysis results of the first phase 1 dose-escalation clinical trial of HMPL-689 were announced

Specifically, of the 51 patients whose efficacy can be evaluated, 6 patients achieved complete remission (2 were chronic lymphocytic leukemia/small B-cell lymphoma, 4 were follicular lymphoma), and 21 patients achieved partial remission.

3.

Indications: Specific locally advanced or metastatic gastric and gastroesophageal junction cancer

FPA144 (bemarituzumab) is a "first-in-class" FGFR2b monoclonal antibody being developed by Amgen

This time, FPA144 is planned to be included in the breakthrough therapy in China.

Prior to this, FPA144 has been used in phase 2 clinical trials in the first-line treatment of patients with advanced gastric cancer or gastroesophageal junction cancer, and has achieved positive results in combination with chemotherapy

Congratulations to these three new anti-tumor drugs to be included in China's breakthrough treatment varieties, and hope that they will progress smoothly in clinical research and bring new treatment options to Chinese patients as soon as possible

references:

[1] Center for Drug Evaluation (CDE) of China National Medical Products Administration.
Retrieved Sep 6, 2021, from http:// Shanghai Haihe Pharmaceutical Research and Development Co.
, Ltd.
Science and Technology Innovation Board IPO prospectus.
Retrieved Feb 03, 2021, from http://kcb.
sse.
com.
cn/renewal/xmxq/index.
shtml?auditId=846&anchor_type= 0

[3] Hutchison Medicine initiates a Phase II registration study of HMPL-689 in China for the treatment of patients with follicular lymphoma and marginal zone lymphoma, Sep 3, 2021, https:// -initiates-phase-ii-registration-study-of-hmpl-689-in-patients-with-fl-and-mzl-in-china/

[4] Five Prime Announces Bemarituzumab Plus Chemotherapy Demonstrates Significant Progression-Free and Overall Survival Benefit Compared to Placebo Plus Chemotherapy in Front-Line Advanced Gastric and Gastroesophageal Junction Cancer.
Retrieved November 10, 2020, from https:// /news/home/20201110006186/en