Suzhou, China, August 11, 2023, CStone Pharmaceuticals (“CStone”, HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, announced today that a research paper entitled “Can a Propensity Score Matching Method be Applied to Assessing Efficacy from Single-Arm Proof-of-Concept Trials in Oncology?” has been published by an internationally recognized journal, Clinical Pharmacology and Therapeutics: Pharmacometrics & Systems Pharmacology.

Due to the rapid increase in the number of new cancer treatment drugs being developed and the escalating competition among pharmaceutical companies, decisions on how to proceed with Phase 3 trials are often based on results from single-arm proof-of-concept (PoC) Phase 1 or Phase 2 studies. These studies compare the efficacy of the study drug to a standard treatment benchmark derived from historical data. However, even when eligibility criteria are matched, differences in the distribution of baseline patient features may influence the outcomes of single-arm trials in real-world scenarios.

Dr. Archie Tse, Chief Scientific Officer of CStone, expressed, “Proof-of-concept data generated from single-arm trials without a concurrent control may sometimes lead to misguided decisions for advancing to Phase 3, as it relies on a comparison against a historical control, which may contain patients with varying baseline feature distributions. To improve the accuracy of efficacy assessment, we applied propensity score matching (PSM) to analyze current and historical cohorts derived from our anti-PD-L1 sugemalimab Phase Ib and Phase III (GEMSTONE-302) trials. Our findings suggest that utilizing the PSM method may provide a less biased means of comparing outcomes between these cohorts relative to a naïve approach, which relies solely on differences in average outcomes.”

Dr. Jason Yang, Chief Executive Officer of CStone, said, “We are delighted to see this meaningful research published in a prominent clinical pharmacology-focused journal. We believe that by using methods like PSM, we can improve the accuracy of drug development decisions, thereby bringing novel medicines more efficiently to patients. The acceptance of our manuscript by an internationally renowned journal signifies that our innovative research has received international recognition. We look forward to applying this method to a wider range of clinical trials, hoping to bring greater benefits to patients.”

Clinical Pharmacology and Therapeutics: Pharmacometrics & Systems Pharmacology is a cross-disciplinary journal devoted to publishing advances in quantitative (e.g., modeling and simulation) methods as applied in pharmacology, physiology and therapeutics in humans.

About CStone

CStone (HKEX: 2616) is a biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established in 2015, CStone has assembled a management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline of 15 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, CStone has received eleven NDA approvals for its four drugs. Multiple late-stage drug candidates are now under pivotal clinical trials or registration. CStone’s vision is to bring innovative oncology therapies to cancer patients worldwide.

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

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