On July 3, 2025, Innovent Biologics, an innovative drug subsidiary of Innovent Biologics (2096.HK), announced that its new generation VEGF-targeted antibody drug Enzeshu® (Suvixitamab) developed in China was approved for marketing by the National Medical Products Administration (approval number: National Medicine Standard S20250037, approval date June 30, 2025), becoming the first targeted therapy in China to cover the entire population of platinum-resistant ovarian cancer. The drug is indicated for combined chemotherapy for the treatment of recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has failed platinum-containing treatment, filling the clinical gap in targeted therapy in this field in my country. This is also the second innovative drug approved for marketing in the innovative pipeline of Innovent Biologics in 2025, following Dalireson.
01 Double survival benefit breaks through the treatment dilemma of platinum-resistant ovarian cancer
The approval of Enzeshu® is based on the world's first Phase III study of vascular targeted drugs to confirm the OS benefit of platinum-resistant ovarian cancer (SCORES). The study was led by Professor Wu Lingying from the Cancer Hospital of the Chinese Academy of Medical Sciences and covered 421 platinum-resistant patients (of which approximately 50% had been treated with anti-VEGF and PARP inhibitors). The data were published in the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting Latest Breakthrough Abstract (LBA) oral report [1] and the 2025 ASCO Annual Meeting poster [2] . The core results include:
Survival breakthrough: The median progression-free survival (PFS) reached 5.49 months (2.73 months in the control group), significantly reducing the risk of disease progression (HR=0.46, P<0.0001); in addition, suvicitamab prolonged overall survival (OS) and reduced the risk of death by 23% (HR=0.77, P=0.0304);
Full population coverage: All pre-set clinical subgroups (regardless of the number of treatment lines, length of platinum-free interval, whether or not patients had received anti-angiogenic therapy, etc.) showed consistent clinical benefits;
Safety advantage: The incidence of adverse events above grade 3 was comparable to that of the control group, and there was no grade 5 suvicitamab-related adverse reaction
Professor Wu Lingying pointed out: "The SCORES study confirmed for the first time that vascular-targeted drugs can bring overall survival benefits to people with platinum-resistant ovarian cancer. The approval of suvicitamab fills a clinical gap and is expected to reshape the anti-angiogenic treatment landscape for ovarian cancer."
02 Differentiated positioning to seize incremental market share
Ovarian cancer has the highest mortality rate among gynecological malignancies. According to statistics from the National Cancer Center in 2024, there are approximately 61,100 new cases and 32,600 deaths in China each year, and this number will continue in the future [3] . Fallopian tube cancer, primary peritoneal cancer, and epithelial ovarian cancer have similar biological characteristics and are often classified as one in treatment. The current main treatment is surgery combined with platinum-containing chemotherapy ± targeted drug maintenance therapy, but most patients will relapse and progress to platinum resistance. Patients with platinum-resistant relapse have a poor prognosis and extremely limited treatment options.
Although anti-vascular endothelial growth factor (VEGF) targeted drugs have shown clear benefits in the treatment of various solid tumors, no vascular targeted drugs have been approved in China for patients with platinum-resistant recurrent ovarian cancer, and chemotherapy is the main treatment method. The approval of Suvicitamab marks a new era of targeted treatment for platinum-resistant ovarian cancer in China, which will bring new options to the entire population of platinum-resistant ovarian cancer who lack effective drugs.
Suvicitamab is a recombinant humanized anti-VEGF monoclonal antibody that precisely blocks the VEGF pathway through a unique molecular epitope design. Preclinical data show that its efficacy in inhibiting angiogenesis and tumor activity is significantly better than similar VEGF target drugs (bevacizumab) [4] . According to the product instructions, the approved dose of Suvicitamab for platinum-resistant ovarian cancer is 1.5 mg/kg (once every 2 weeks), which is only 1/7 of the dose of similar VEGF antibodies (bevacizumab 10 mg/kg once every two weeks or 15 mg/kg once every three weeks).
Suvixitamab was jointly developed by Syngene and Pyxis Oncology. Syngene completed the preclinical and clinical studies of Enzeshu®, and completed cell line screening, process development and clinical sample production based on Syngene's own technology platform. After approval, commercial production will be carried out by Syngene's Nanjing Antibody Factory. With Syngene's annual production capacity of 6 million antibody biologics and a marketing network covering nearly 3,000 hospitals across the country, Suvixitamab can quickly achieve sufficient supply across the country. In addition, Suvixitamab was approved in the middle of the year and is expected to be included in medical insurance in the year of listing, thus covering the incremental market that was previously only covered by other similar products in China, while greatly benefiting the Chinese platinum-resistant ovarian cancer patient population.
Suvicitamab is the second innovative product approved in June 2025 after Daliresan Hydrochloride Tablets in the innovative pipeline of Innovent Biologics. Benefiting from the continuous high-intensity R&D investment of Innovent Biologics Group in recent years, the company has launched 10 innovative drugs, including 8 approved in the past five years, and the company's innovative transformation has begun to show results. In 2024, the proportion of Innovent's innovative drug revenue has exceeded 74%. As innovative products are launched one after another, the proportion of innovative drug business will be further consolidated and expanded.

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