Sinovac Pharma's Apexelsin Obtains Drug Registration Certificate in Uzbekistan

en.Wedoany.com Reported - On September 4, Sinovac Pharma announced that its overseas product, Paclitaxel (Albumin-Bound) for Injection Apexelsin®, has recently passed the review of the Drug Safety Center under the Ministry of Health of Uzbekistan and obtained a drug registration certificate. The Drug Safety Center under the Ministry of Health of Uzbekistan is responsible for the registration management of pharmaceuticals and medical devices in the country and maintains the national drug registration directory approved for use in medical practice.

Apexelsin® is an anti-tumor product that Sinovac Pharma collaborates on for overseas distribution with Zhejiang Haichang Bio-Technology Co., Ltd., primarily used for the treatment of metastatic breast cancer, metastatic pancreatic cancer, and non-small cell lung cancer. The product obtained the "Drug Registration Certificate" issued by China's National Medical Products Administration in October 2023, received marketing authorization from the European Commission in July 2024, and obtained marketing authorization from the UK Medicines and Healthcare products Regulatory Agency in October of the same year.

Since 2026, Apexelsin® has continued to secure market access in multiple overseas regions. In March, the product obtained marketing authorization in Macao, China, and Malaysia; in April, it successively received marketing approvals in the Dominican Republic, the Philippines, and the United Arab Emirates. According to data released by Sinovac Pharma at the end of April, Apexelsin® had by then been approved for marketing in more than 30 countries and regions, including the UK, Peru, Uruguay, Argentina, Oman, Malaysia, Macao (China), Georgia, the Dominican Republic, and the Philippines.

Sinovac Pharma's 2026 semi-annual report shows that in the first half of this year, the company added 32 new overseas registration submissions and obtained 29 new approvals, of which albumin-bound paclitaxel secured 7 new approvals in emerging markets. As of the end of 2025, the company had submitted approximately 150 overseas registration applications in over 70 countries and regions, and its albumin-bound paclitaxel production line had passed relevant inspections under the EU pharmaceutical regulatory system.