Qilu Pharmaceutical Tops April 2025 Clinical Trial Filings with Six New Studies Across Diverse Pipeline

Distribution of Drug Clinical Trials

In April 2025, according to the [China Clinical Trial/Clinical Research Analysis System] database of PharmData, the CDE disclosed a total of 535 registered drug clinical trials. Among them, chemical drug clinical trials accounted for the majority with 400 trials, while biologics and traditional Chinese medicine had 122 and 12 trials, respectively.

In terms of trial phases, the "Other" category accounts for the largest proportion, reaching 44.7%, with a total of 239 trials, and the majority of these trials are bioequivalence (BE) studies of chemical drugs. This is followed by Phase 1 trials, with a total of 140 studies, while the numbers of Phase 2 and Phase 3 trials are 54 and 69, respectively. Phase 4 clinical trials are the fewest.

Analysis of Drug Clinical Trial Varieties

In the top 10 list of drug clinical trial varieties registered with the CDE in April 2025, "Finerenone Tablets" topped the list with 9 registered trials, all of which were bioequivalence trials. These 9 trials were registered by 9 companies, including Nantong Lianya Pharmaceutical Co., Ltd., Tianda Pharmaceutical (Zhuhai) Co., Ltd., and Hainan Hailing Chemical Pharmaceutical Co., Ltd. The clinical trial indications targeted were all "chronic kidney disease (CKD) associated with type 2 diabetes (T2D)."

At the same time, ranked second on the top 10 list of drug clinical trial varieties registered with the CDE in April 2025 is "Esomeprazole Enteric-Coated Tablets," with a total of 6 registered trials, all of which are BE trials for the treatment of duodenal ulcers and reflux esophagitis. For more detailed information, please see the figure below or visit the PharmaData "China Clinical Trial Database/Clinical Research Analysis System" for inquiries.

Note: Due to the presence of ties, the above ranking includes more than 10 varieties.

Analysis of Drug Clinical Trial Application Units

In the April 2025 CDE Drug Clinical Trial Sponsor Rankings, "Qilu Pharmaceutical Co., Ltd." tops the list with six registered clinical trials. These six trials cover six different types of clinical trials, specifically three chemical drugs: "Abaloparatide Injection, QLM1016, Tafamidis Meglumine Soft Capsules," and three biologics: "Denosumab Injection, QLS31905 for Injection, QLP2117 Injection."

Following closely behind are "Hunan Jiudian Pharmaceutical Co., Ltd. and Zhejiang Huahai Pharmaceutical Technology Co., Ltd.," tied for second place. Among them, the clinical trials of Hunan Jiudian Pharmaceutical Co., Ltd. include both new drug development clinical trials and generic drug bioequivalence trials, while all clinical trials of Zhejiang Huahai Pharmaceutical Technology Co., Ltd. are generic drug bioequivalence trials.

Note: Due to ties, there are more than 10 clinical trial sponsors in the ranking above.

Analysis of Drug Clinical Trial Institutions

In the CDE drug clinical trial registration public announcement for April 2025, "Hangzhou First People's Hospital" ranked first with 14 leading clinical trials, including 4 new drug clinical trials and 10 bioequivalence trials. "Fudan University Cancer Hospital" followed in second place with 13 leading clinical trials, all of which were new drug clinical trials. For more details, please see the figure below or visit the PharmaData "China Clinical Trial Database/Clinical Research Analysis System" for inquiries.

Note: Due to the presence of ties, only the top 10 leading institutions for clinical trials are listed in the above ranking.

Key Events in Clinical Outcomes

In April 2025, Akeso Biopharma's PD-1/VEGF bispecific antibody Ivonescimab reached the primary endpoint in a Phase 3 trial comparing it to Tislelizumab for first-line treatment of advanced squamous non-small cell lung cancer, showing a significant extension in median progression-free survival.

Suzhou Shizhe Bio's iPS-Derived Dopaminergic Neural Progenitor Cell Therapy XS411 Approved for Clinical Trials, Covering Indications for Both Idiopathic and Early-Onset Parkinson's Disease

AKT Inhibitor Approved in China: AstraZeneca's Capivasertib has been approved for marketing in China, to be used in combination with fulvestrant for the treatment of specific breast cancer patients, becoming the first AKT inhibitor in China.

Data sources of this report: PharmaSmart Enterprise Edition_China Clinical Trial Database, PharmaSmart Enterprise Edition_Clinical Research Analysis System

Editor: Muyan

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