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First-in-Class Innovation Recognized Again! Culmerciclib Capsules Awarded "CPIC 2026 Original New Drug Award"

Release Date: 2026-07-24

On July 22, the inaugural China Pharma Innovation Conference (CPIC 2026) opened at the Shanghai National Exhibition and Convention Center. The "CPIC 2026 Original New Drug Award" was officially announced at the conference. The first-in-class CDK2/4/6 inhibitor, Culmerciclib capsules (Saitanxin®), self-developed by CTTQ, the core enterprise of SBP Group (1177.HK), received the award, showcasing Sino Biopharm's strength in pursuing source innovation to address significant clinical needs. Tse Hsin, Executive Director and Senior Vice President of SBP Group, attended the conference. 

 

 

The "CPIC 2026 Original New Drug Award" focuses on original new drugs that were first launched globally in China within the last 5 years, with technological breakthrough, significant clinical value, and market potential as the core evaluation criteria. The fairness and impartiality of the selection were ensured by an independent third-party verification agency. After voting by professional judges from the pharmaceutical industry and a comprehensive assessment by the conference organizing committee, 7 breakthrough new drugs were ultimately selected. 

 

HR+/HER2- is the most common molecular subtype of breast cancer. Currently, CDK4/6 inhibitors combined with endocrine therapy have become an important treatment option for advanced HR+/HER2- breast cancer, but acquired drug resistance and safety management in long-term treatment remain significant clinical challenges. Starting from clinical pain points, Culmerciclib mechanistically delays or overcomes drug resistance mediated by compensatory activation of CDK2 by enhancing the selective inhibitory effect on CDK2 and CDK4 while reducing inhibition of CDK6, thereby achieving a balance between anti-tumor efficacy and bone marrow safety. 

 

In December 2025, Culmerciclib was approved for marketing by the National Medical Products Administration (NMPA) in combination with fulvestrant for patients with locally advanced or metastatic HR+/HER2- breast cancer who have previously received endocrine therapy, becoming the world's first approved CDK2/4/6 inhibitor. In May 2026, Culmerciclib was approved for a first-line indication, in combination with fulvestrant for the initial endocrine therapy of patients with locally advanced or metastatic HR+/HER2- breast cancer. 

 

The clinical accessibility of Culmerciclib is a microcosm of the acceleration of Chinese innovative drugs from "follow-on innovation" to "source innovation". In recent years, domestically developed innovative drugs have made continuous breakthroughs in novel targets, novel mechanisms, and global first launches, and China is increasingly becoming an important source of global pharmaceutical innovation. Data from a report by the Information Technology and Innovation Foundation (ITIF) shows that from 2016 to 2025, China's share of the world's most innovative drug clinical trials increased six-fold, reaching 30%. 

 

As a leading innovation and R&D-driven pharmaceutical group in China, SBP Group has always been guided by unmet clinical needs, focusing on four major therapeutic areas: oncology, liver disease/cardiovascular-metabolic, respiratory/autoimmune, and surgery/analgesia. It continuously improves its full-chain innovation system from drug discovery and clinical development to production and commercialization. The company has established cutting-edge technology platforms for bispecific antibodies, ADCs, PROTAC, and small nucleic acids, and enhances the originality and global competitiveness of its innovative pipeline through diverse pathways such as in-house R&D, international collaboration, business development, and investment and M&A. 

 

Looking to the future, SBP Group will uphold the vision of "Focus on Innovation, Serve Patients, and Become a Leading Global Pharmaceutical Company". It will focus on major disease areas and real-world clinical needs, promote more globally competitive innovative achievements, and benefit patients worldwide with safer, more effective, and accessible treatment options. 

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