The localized supply of Pralsetinib capsules has officially commenced! The first batch of locally produced products has been commercially shipped.

Suzhou, China, May 11, 2026 - CStone Pharmaceuticals (Stock Code: 2616.HK), an innovation-driven biopharmaceutical company focusing on drug research and development in key areas such as oncology, immunology, and inflammation, announced today that the first batch of locally manufactured Pralsetinib capsules (100 mg), a highly selective RET inhibitor, has completed production and release, and nationwide commercial shipments have officially started. This marks a crucial step towards the localization of the domestic supply chain for this innovative drug.

Shipping scene of the first batch of locally manufactured Pralsetinib capsules

Pralsetinib capsules were included for the first time in the 'National Reimbursement Drug List for Basic Medical Insurance, Maternity Insurance, and Work-related Injury Insurance' ('National Reimbursement Drug List') at the end of 2025, effective from January 1, 2026. Benefiting from the significant improvement in patient accessibility due to the inclusion in the National Reimbursement Drug List, by April 2026, terminal sales of Pralsetinib capsules had increased more than 430% compared to the same period last year. Based on this growth trend, full-year revenue from Pralsetinib capsule sales in 2026 is expected to exceed 300 million RMB.

The terminal sales volume of Pralsetinib capsules increased by over 430% year-over-year

Dr. Jason Yang, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, stated: 'The successful shipment of the first batch of locally produced Pralsetinib capsules is a result of our production, quality, regulatory, and supply chain teams strictly adhering to international standards and working together efficiently. Through rigorous technology transfer and process validation, we have ensured that the locally produced product is highly comparable to the imported product in terms of quality and efficacy. As our localized production and supply system matures, we will fully meet the clinical demand unleashed after the implementation of the national medical insurance directory, ensuring the accessibility and stable supply of the drug. Additionally, full-chain localization will significantly optimize our cost structure and enhance profitability resilience and commercial vitality. Looking ahead, CStone Pharmaceuticals will continue to adhere to our original mission, ensuring the stable supply of high-quality drugs to benefit more patients in China.'

About Pralsetinib capsules

Pralsetinib capsules are an orally administered, once-daily, potent, and highly selective RET inhibitor. It has been approved by the National Medical Products Administration (NMPA) for first-line treatment of adult patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC), for treating adult patients with locally advanced or metastatic RET fusion-positive NSCLC previously treated with platinum-based chemotherapy, and for patients with RET fusion-positive thyroid cancer (TC). Furthermore, the drug has been approved by the Hong Kong Department of Health for treating patients with locally advanced or metastatic RET fusion-positive NSCLC, and by the Taiwan Food and Drug Administration (TFDA) for treating adult patients with locally advanced or metastatic RET fusion-positive NSCLC and advanced or metastatic RET fusion-positive TC.

The US Food and Drug Administration (FDA) approved its sale under the brand name GAVRETO®, with indications as follows:

- For the treatment of adult patients with metastatic RET fusion-positive NSCLC confirmed by an FDA-approved test method; and

- Adult and pediatric patients aged 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are radioactive iodine-refractory (if applicable).*

*The indication for thyroid cancer was granted accelerated approval based on objective response rate (ORR) and duration of response (DOR) data. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Pralsetinib capsules were developed by Blueprint Medicines Corporation, a partner of CStone Pharmaceuticals (acquired by Sanofi in July 2025). CStone Pharmaceuticals holds exclusive development and commercialization rights for Pralsetinib capsules in Greater China (including mainland China, Hong Kong, Macau, and Taiwan). In November 2023, CStone Pharmaceuticals granted Shanghai Allist Pharmaceuticals Technology Co., Ltd. exclusive commercial promotion rights for Pralsetinib capsules in mainland China.

About CStone Pharmaceuticals

CStone Pharmaceuticals (HKEX: 2616), founded at the end of 2015, is an innovation-driven biopharmaceutical company focused on drug development in key disease areas such as oncology, immunology, and inflammation, committed to meeting the pressing medical needs of patients in China and globally. To date, the company has successfully launched four innovative drugs, received approval for 21 new drug applications (NDAs), and obtained nine indications. The current R&D pipeline includes a balanced portfolio of 16 candidate drugs, comprising antibody-drug conjugates (ADCs), multispecific antibodies, as well as immunotherapies and precision medicines. Additionally, CStone Pharmaceuticals boasts a seasoned management team with 'end-to-end' coverage spanning preclinical exploration, clinical translation, clinical development, drug manufacturing, business development, and commercial operations. For more information about CStone Pharmaceuticals, please visit: www.cstonepharma.com.

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