3 new drugs are planned to be included in breakthrough therapy! From Hutchison Medicine, Haihe Medicine, Amgen

September 06, 2021

According to the latest announcement by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, Haihe Pharmaceuticals/Shanghai Institute of Materia Medica, Chinese Academy of Sciences c-Met inhibitor glutamine tablets, Hutchison Whampoa small molecule PI3Kδ inhibitor HMPL-689 capsules, Amgen FGFR2 monoclonal antibody FPA144 injection was included in the proposed breakthrough treatment product.

Source: CDE official website

Gumatinib Tablets

Haihe Pharmaceuticals/Shanghai Institute of Materia Medica, Chinese Academy of Sciences c-Met inhibitor glutmetinib tablets are planned to be included in the breakthrough therapy category for the treatment of locally advanced or metastatic non-small cell lung cancer with MET14 exon jump. c-Met is a receptor expressed on the cell surface, and its ligand is hepatocyte growth factor (HGF). A large number of studies have shown that excessive activation of c-Met may initiate the transformation of normal cells into tumor cells, and further drive the occurrence of subsequent events such as invasion, metastasis, and spread. Many clinical findings in recent years also show that c-Met gene mutations are the key to drug resistance in many tumors. Glumetinib (Code: SCC244) is a potent and selective small molecule c-Met inhibitor with global independent intellectual property rights developed by Haihe Pharmaceuticals and Shanghai Institute of Materia Medica, Chinese Academy of Sciences. Pre-clinical studies have shown that 50 mg/kg of glutamine has a strong tumor suppressor effect.

HMPL-689 capsule

Hutchison Whampoa HMPL-689 Capsules is intended to be included in the breakthrough therapy category, used for monotherapy for those who have received at least second-line systemic therapy in the past, and at least one of them includes CD20 monoclonal antibody (CD20 monoclonal antibody single-agent therapy or combination chemotherapy) Patients with relapsed/refractory FL (pathological grade Grade 1-3a). HMPL-689 is a new, potent and highly selective small molecule PI3Kδ inhibitor that is expected to become the best in class. In preclinical pharmacokinetic studies, it was confirmed that HMPL-689 has good oral absorption, moderate tissue distribution and low clearance rate. Preclinical studies also expect that HMPL-689 has a lower risk of drug accumulation and drug-drug interactions, and is active at the level of whole blood. Hutchison Medicine is synchronizing the clinical development of HMPL-689 globally. The company expects to complete regulatory discussions with the FDA in the second half of this year, and to start the registration intention study for indolent non-Hodgkin's lymphoma at the end of this year.

FPA144 injection

Amgen FPA144 injection (bemarituzumab) is intended to be included in the breakthrough treatment product, and combined with mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) for the first-line treatment of FGFR2b overexpression (immunohistochemical detection of at least 10% of tumor cells overexpressing FGFR2b) ), human epidermal growth factor receptor (HER2) negative locally advanced or metastatic gastric and gastroesophageal junction cancer (GEJ) patients. Bemarituzumab is an isoform-selective monoclonal antibody targeting FGFR2. Two mechanisms of action are used to inhibit tumor growth: ① Targeting the splice variant FGFR2b, inhibits the binding of ligands FGF7, FGF10, and FGF22, thereby inhibiting several downstream pathways. ②By recruiting natural killer cells, it can enhance antibody-dependent cell-mediated cytotoxicity (ADCC) to directly kill tumor cells. Bemarituzumab is characterized by not inhibiting metabolism-related FGF23, thus avoiding the risk of hyperphosphatemia associated with pan-FGFR inhibitors.Bemarituzumab was originally developed by Five Prime. In March 2021, Amgen acquired Five Prime for US$1.9 billion and included bemarituzumab. In December 2017, Zai Lab and Five Prime reached an agreement to obtain the exclusive license right to develop and commercialize bemarituzumab in Greater China for US$44 million. In April of the same year, the drug obtained the breakthrough therapy designation granted by the FDA.

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