November 13-14, World Companion Diagnostics & Liquid Biopsy Summit APAC (“The Summit”) arrived in Singapore to provide an exceptional platform for knowledge sharing, collaboration, and the exchange of innovative ideas. Over 100 industrial professionals and experts working in the fields of Precision Medicine, Companion Diagnostics (CDx), Biomarker Development, Regulation, etc. from across the Asia-Pacific region gathered to accelerate bringing precision therapeutics to patients in oncology and other fields. Dr. Qingmei Shi, CMO of CStone Pharmaceuticals (“CStone”), was invited as an expert speaker to share views and experiences on the co-development of precision medicine and CDx in China based on CStone's experience.

The Summit brought together leading experts from biopharmaceutical companies such as Amgen, AstraZeneca, Johnson & Johnson and CStone, top scholars from academic institutions such as Fudan University and National University of Singapore, and world-class service providers to discuss the latest advancements in biomarker development, liquid biopsy testing, and CDx, and share valuable insights into the industry's biggest challenges and opportunities, including regulatory updates, diversified payment system, and innovative strategies for accelerating patient access to precision therapies.

Dr. Shi's presentation, titled “Hands on Experience with Case Studies of Precision Medicine & CDx Co-Development in China”, focused on sharing views and experiences on drug and CDx co-development in China from pharma's perspective, and National Medical Products Administration (NMPA)'s requirements on clinical validation data of CDx in clinical trials. Dr. Shi also discussed the key success factors to improve the possibility of success for CDx approval, including clinical trial design, selection and validation of biomarkers, and communication strategies with regulatory authorities.

“ The development of CDx is a critical component in the creation of precision therapies,” said Dr. Shi during her presentation. “The deployment of a CDx strategy should be integrated with the clinical development plan from the beginning. Seamless, cross-functional collaboration is essential to achieving both scientific and operational success. However, co-approval of CDx and therapies remains challenging and requires ongoing innovation from both the pharmaceutical industry and regulatory authority. ”

CStone has been a pioneer in the research and development of precision therapies, with two commercialized products on the market – AYVAKIT^® (avapritinib) and GAVRETO^®s' (pralsetinib). The Company has partnered with Hengrui Pharmaceuticals and Allist to commercialize AYVAKIT^® (avapritinib) and GAVRETO^® (pralsetinib) in mainland China. The NMPA has approved the manufacturing localization application of AYVAKIT^®, and a same application for GAVRETO^® is currently under review. CStone co-developed AYVAKIT^® (avapritinib) CDx with CDx partner in China, which is the first CDx developed in China that was approved using a bridging pathway, following the two new CDx guidelines. CStone's blockbuster Cejemly® (Sugemalimab) is the world's first anti-PD-L1 monoclonal antibody approved for the first-line treatment of gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, in which CStone is also actively collaborating with partner for PD-L1 expression CDx development.

About CStone

CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies. Dedicated to addressing patients' unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 16 new drug applications (NDAs) covering 9 indications. The Company’s pipeline is balanced by 18 promising candidates, featuring potentially first-in-class or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization.

For more information about CStone, please visit: www.cstonepharma.com.

IR contact: ir@cstonepharma.com

PR contact: pr@cstonepharma.com

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