Two Anticancer Drugs Approved in China, Including a Domestic Class 1 Innovative Drug

　　【Pharmaceutical Network Industry DynamicsLast week, two new anti-tumor drugs were approved for marketing in China, namely Alpha Biopharma's Zolitinib Hydrochloride Tablets and Merck's Bezuclifene Tablets.
 

According to the news on the website of the National Medical Products Administration, Alpha Biopharma's Class 1 innovative drug Zorifertinib Hydrochloride Tablets has been approved for marketing. This drug is suitable for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations and are accompanied by central nervous system (CNS) metastases, providing a new treatment option for patients.
 

Lung cancer is one of the cancers with the highest global incidence. Among lung cancer patients, non-small cell lung cancer accounts for about 80%, and approximately 75% of patients are diagnosed at an advanced stage, with a low 5-year survival rate. Zoritini is a drug that has conducted registration clinical trials specifically targeting advanced non-small cell lung cancer with central nervous system metastases and achieved results. As an EGFR tyrosine kinase inhibitor explicitly designed using a non-blood-brain barrier efflux protein substrate, it possesses a high ability to penetrate the blood-brain barrier.
 

The approval of Zoritini is mainly based on the positive results of the II/III phase EVEREST study. This study is a randomized, open-label, international multi-center II/III phase clinical trial (n=492), and it is also the largest prospective international multi-center clinical trial to date for patients with EGFR gene mutation-positive non-small cell lung cancer accompanied by central nervous system metastasis.
 

On November 21, Merck's Belzutifan Tablets received NMPA approval for marketing in China, indicated for the treatment of patients with Von Hippel-Lindau (VHL) disease-associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors who do not require immediate surgery.
 

Data show that Belzutifan is an investigational, novel, potent, selective oral HIF-2α inhibitor that can reduce the transcription and expression of HIF-2α target genes associated with cell proliferation, angiogenesis, and tumor growth.
 

Belzutifan can bind to and stabilize the α subunit of HIF, thereby preventing it from entering the nucleus and activating the expression of downstream genes. This mechanism of action allows belzutifan to inhibit angiogenesis and cell proliferation in VHL disease-associated tumors, thereby achieving the goal of controlling tumor growth. This discovery provides new ideas and methods for the treatment of VHL disease and lays a solid foundation for the development of belzutifan.
 

Reportedly, the development of Bezuclifene has undergone years of scientific research and clinical trials. During the clinical trials, Bezuclifene demonstrated a good safety profile without presenting new safety concerns. The incidence of treatment-related adverse events was similar to that of the control group, and the percentage of grade 3 to 5 adverse events was also comparable. This indicates that Bezuclifene offers significant efficacy while maintaining favorable safety and tolerability. For patients, this means they can experience reduced discomfort and risk from drug side effects during Bezuclifene treatment. This is of great significance for improving patients' quality of life and prolonging survival.
 

Merck's Belzutifan was granted accelerated approval by the FDA in August 2021 and received another FDA approval in December 2023 for the treatment of advanced renal cell carcinoma (RCC) patients who have undergone PD-(L)1 and anti-VEGF drug therapies. This approval for marketing in China will bring a new treatment option to relevant patients.
 

In addition, according to the review, last week several innovative drug clinical trial applications (IND) were accepted by the CDE. These include HX044 Injection developed by Hansi Aitai, an investigational bispecific antibody for cancer immunotherapy independently developed by the company; JSKN033 Injection from Alphamab Oncology, a high-concentration compound formulation of ADC and PD-L1 inhibitor administered via subcutaneous injection; and INCB057643 Tablets from Incyte, a BET inhibitor that regulates the expression of key oncogenic proteins associated with the pathophysiology of hematologic malignancies, including myelofibrosis (MF).
 

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