On the afternoon of November 30, 2024, the 2024 China BioMed Innovation and Investment Conference (CBIIC) was successfully held in Guangzhou, with its global debut of Clinical Trial Data Release Roadshow becoming the focal point. During this roadshow, 9 drugs in various stages of development and already on the market were showcased, with a series of key clinical data being revealed for the first time, drawing significant attention and acclaim from investors and professionals in the pharmaceutical industry.

Moderator: Zhang Dan, Executive Chairman of ClinChoice, Co-founder and Co-chairman of Jiangsu Hillgene Biopharma Co., Ltd.

This roadshow featured 9 innovative drugs presenting key trial data, primarily focusing on treatment areas such as cancer and metabolic diseases.

Project 1: TQB3616 in Combination with Fulvestrant for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer: A Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial

TQB3616 is a novel oral CDK2/4/6 inhibitor developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. products. The research presented in this session highlights the world’s first positive Phase III results for an oral CDK2/4/6 inhibitor combined with endocrine therapy. The TOB3616-III-01 study is a randomized, double-blind, parallel-controlled Phase III clinical trial designed to assess the efficacy and safety of TOB3616 combined with Fulvestrant in patients with HR+/HER2- advanced breast cancer previously treated with endocrine therapy. The results show that TOB3616 in combination with Fulvestrant significantly reduces the risk of disease progression or death, and effectively improves objective response rate, clinical benefit rate, overall survival, and other key outcomes. Compared to historical study data, the median progression-free survival (PFS), hazard ratio (HR), and extent of PFS improvement achieved with the TOB3616 combination regimen surpass the clinical benefits observed with existing standard treatments.

Presenter: Yin Yongmei, Associate Dean, Jiangsu Women and Children Health Hospital, Jiangsu Province Hospital

Project 2: Clinical Study of Dorzagliatin Tablets on Improving Beta-cellGlucose Sensitivity

Dorzagliatin Tablets (Huatongning®) are the world’s first glucose kinase activator (GKA) developed independently by Hua Medicine. Dr. Li Chen, CEO of Hua Medicine (Shanghai) Co., Ltd., presented the clinical study results of the “SENSITIZE” mechanism verification and the single-dose SAD (Single Ascending Dose) clinical study of the second-generation glucose kinase activator.The SENSITIZE study results show that a single dose of Dorzagliatin Tablets significantly improves beta-cell glucose sensitivity and biphasic insulin secretion in diabetic patients of varying severity. The results of the single-dose escalating (SAD) trial for the second-generation glucose kinase activator HM-002-1005 (184.5mg) showed exposure levels equivalent to 75mg BID of Dorzagliatin Tablets, achieving the goal of optimizing the dosing regimen.

Presenter: Chen Li, CEO of Hua Medicine (Shanghai) Co., Ltd.

Project 3: A Recombinant Human Serum Albumin from Oryza Sativa (OsrHSA) Reached its Study Endpoints in a Phase 3 Pivotal Clinical Trial

Recombinant Human Serum Albumin Injection (Aofumin®) is a medicinal human serum albumin developed independently by He Yuan Biotech, with support from China’s “12th Five-Year” and “13th Five-Year” major new drug creation programs. The Phase 3 pivotal clinical trial results demonstrate that in patients with cirrhotic hypoalbuminemia, the plant-derived recombinant human serum albumin injection (OsrHSA) at a dosage of 20g/day for up to 14 days effectively increased serum albumin levels. The efficacy of OsrHSA was non-inferior to that of human plasma-derived albumin (pHSA), and it maintained comparable therapeutic stability during the follow-up period. The trial successfully met the primary endpoints outlined in the clinical study design, showing favorable safety. No clinically meaningful drug-specific antibodies or anti-HCP antibodies were generated during the study.

Presenter: Yang Daichang, Chairman, Wuhan Healthgen Biotechnology Corp.

Project 4: Leading Metabolic Health, First Release of Efsubaglutide Alfa Metabolic Data

Efsubaglutide Alfa, developed by Innogen Pharmaceutical, is China’s first next-generation human-derived ultra-long-acting GLP-1 receptor agonist with independent intellectual property. Results from Phase III clinical trials of Efsubaglutide Alfa monotherapy and combination with Metformin in treating Type 2 Diabetes (T2D) show excellent achievement rates: in patients with baseline HbA1c < 8.5%, 68.6% of patients on Efsubaglutide Alfa monotherapy and 81.5% on combination therapy reached HbA1c target after 24 weeks. Rapid onset and strong glycemic control were observed, with a reduction of 1.1% in HbA1c after 4 weeks and 2.2% after 24 weeks. In weight loss studies in non-diabetic individuals, Efsubaglutide Alfa demonstrated a weight loss of 4 kg after 4 weeks, with a total weight reduction of 6.2%, and 71% of participants showed a weight loss ≥ 5%.

Presenter: Xu Wenjie, Senior Vice President, Chief Commercial Officer, Shanghai Innogen Pharmaceutical Technology Co., Ltd.

Project 5: Efficacy and Safety of Axicabtagene Ciloleucel (Axi-cel) for the Treatment of Relapse/Refractory Non-hodgkin’s Lymphoma: Real-world Data in Chinese Population

Axi-cel Injection (Yikeda®), China’s first approved CAR-T therapy, developed by KITE and licensed to Fosun Kite, was evaluated in a study with 201 participants. As of May 31, 2024, 201 patients were assessed with a median follow-up of 17.6 months. The study showed a bORR of 83.1%, bCR rate of 67.2%, and median PFS of 15.5 months, with a 24-month OS rate of 75.2%. Safety analysis indicated no new adverse events in the Chinese population. Cytokine release syndrome (CRS) was observed in 85.6% of participants, with 10.4% experiencing Grade ≥3 CRS, in line with global studies (ZUMA-1, CIBMTR). Neurologic events occurred in 25.4% of patients, with 3.5% having Grade ≥3 events, lower than in global data. These findings support the outstanding efficacy and improved safety of Axi-cel in treating R/R NHL in China.

Presenter: Zhao Jinghua, Chief Medical Officer, Shanghai Fosun Kairos Biotechnology Co., Ltd.

Project 6: Glecirasib in Combination with JAB-3312 (SHP2 inhibitor) in Advanced Solid Tumors Harboring KRAS G12C Mutation

Glecirasib is an innovative small-molecule KRAS G12C covalent inhibitor developed by Jacobio Pharmaceuticals, and JAB-3312, a selective SHP2 allosteric inhibitor, were combined to enhance anti-tumor effects. The trial included 194 patients with advanced solid tumors. Preliminary data show excellent safety and tolerance, with no drug interactions or toxicity accumulation. In KRAS G12C-mutated first-line non-small cell lung cancer (NSCLC), the combination therapy exhibited excellent clinical efficacy, with an ORR of 70.6% and median PFS of 12.2 months. Additionally, strong efficacy was observed across various PD-L1 stratifications. 

Presenter: Ding Yuli, Senior Vice President, Clinical Development of Jacobio Pharmaceuticals

Project 7: Randomized, Open-label, Phase III Study of SAF-189s Versus Crizotinib in First-Line ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

SAF-189s, a highly active next-generation ALK/ROS1 inhibitor with high brain penetration, is being studied in the REMARK Phase III trial (NCT06569420) as a first-line treatment for ALK-positive NSCLC. Mid-term analysis revealed significantly improved progression-free survival (PFS) and overall survival (OS) in patients who had not previously received ALK-TKI treatment, compared to Crizotinib. SAF-189s was also shown to lower the risk of central nervous system progression, with no new safety signals.

Presenter: Wu Zhuli, Senior Vice President, CMO (oncology), Fosun Pharma Global R&D Center

Project 8: The Treatment of Chiglitazar for Metabolic Associated (Non-Alcoholic) Steatohepatitis: A randomized, Double-blind, Placebo-Controlled Phase II Clinical Trial

Chiglitazar (Shuangluoping®), developed by Shenzhen Chipscreen Biosciences, is a full agonist of peroxisome proliferator-activated receptor (PPAR), approved in China for Type 2 diabetes. In a Phase II trial for Metabolic-Associated Steatohepatitis (MASH), the drug significantly reduced liver fat content, inflammation, and injury, with potential fibrosis improvement. The treatment showed excellent safety and tolerance, with promising results for MASH treatment. 

Presenter: Pan Desi, Vice President & CSO, Shenzhen Chipscreen Biosciences Co., Ltd.

Project 9: First-line Serplulimab Plus Bevacizumab and XELOX Versus Placebo Plus Bevacizumab and XELOX in Metastatic Colorectal Cancer

Serplulimab (Hansizhuang®) is a PD-1 inhibitor independently developed by Fuhong Hanlin. In the Phase 2/3 clinical trial, a total of 114 patients were enrolled and randomly assigned to either the serplulimab group (n = 57) or the placebo group (n = 57). As of December 15, 2023, the median follow-up time was 24.4 months. The serplulimab group showed significant improvements in both median progression-free survival (mPFS) and overall survival (mOS) compared to the placebo group (mPFS: 16.8 vs. 10.7 months, hazard ratio [HR], 0.58; mOS: not reached vs. 21.2 months, HR, 0.74). Similar benefits were also observed in the MSS and KRAS mutation subgroups. Overall, serplulimab combined with bevacizumab and XELOX demonstrated good efficacy and safety in treatment-naive patients with metastatic colorectal cancer (mCRC).

 Presenter: Li Jing, Global Product Development General Manager, Shanghai Henlius Biotech, Inc.

 The Clinical Trial Data Release Roadshow, held consecutively for nine years, has showcased key clinical data from 78 innovative drugs to attendees. These achievements have significantly enriched clinical treatment options and brought dual benefits to both patients and investors. We look forward to further collaboration between innovation and capital to drive the development of domestic innovative drugs, benefiting more patients.