Qilu Pharmaceutical Tops March 2026 Clinical Trial Filings with 12 Submissions-VCBeat

Introduction: Clinical Trial Report for March

Distribution of Clinical Trial Types

In March 2026, according to the 【China Clinical Trials】database in the Pharma Data Enterprise Edition, the CDE disclosed and registered a total of drug clinical trials.498 itemsClinical trial registration. Among them, chemical drug clinical trials account for the majority with 345 trials, while biologics and traditional Chinese medicine have 142 and 11 trials, respectively.

In terms of trial phases, the largest proportion is "Other" clinical trials, reaching 36.3%, with a total of 181 trials, and the majority of these trials are bioequivalence studies of chemical drugs. Next are "Phase 1" trials, with a total of 171 studies, while the numbers of Phase 2 and Phase 3 trials are 96 and 69, respectively. There are only 8 Phase 4 clinical trials.

Note: Due to the fact that the same clinical trial may belong to multiple clinical stages.Situation, so the above statistical number will be more than the total number of clinical trials.

Analysis of Drug Clinical Trial Varieties

In the top 10 list of drug clinical trial varieties registered with CDE in March 2026,"Finerenone Tablets" Tops the List with 12 Registered Trials, and all are bioequivalence clinical trials. The 12 clinical trials for "Finerenone Tablets" were sponsored by Zhejiang Brothers Pharmaceutical Co., Ltd., Suzhou Pharmaceutical Factory of Jiangsu Wu Zhong Medicine Group Co., Ltd., Qilu Pharmaceutical Co., Ltd., and other companies. The indications targeted in these clinical trials are all "adult patients with chronic kidney disease associated with type 2 diabetes (with albuminuria), to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage renal disease, cardiovascular death, and hospitalization due to heart failure." "Dotinurad Tablets" ranks second with eight clinical trials, all of which are bioequivalence clinical trials.

More detailed information,Please see the figure below for details.Or visit the enterprise version of Yaozhi Data [Clinical Trials in China] Query the database.

Note: Due to the presence of ties, the above ranking may include more than 10 entries.

PS：Reply to the Yaoke Data WeChat Official Account backend [Clinical 2026], ObtainFull Report PDF Version。

Analysis of Drug Clinical Trial Application Units

InIn the CDE Drug Clinical Trial Sponsor Rankings for March 2026,Qilu Pharmaceutical Co., Ltd. Tops the List with 12 Clinical Trial Registrations"Qilu Pharmaceutical Co., Ltd." conducted 12 trials covering clinical trials of 10 different varieties, including both new drug clinical trials and bioequivalence trials, specifically for "Finerenone Tablets, Dotinurad Tablets, Idebenone Tablets, QL2109 Injection," among others. "Sinovac Life Sciences Co., Ltd." ranked second with five registered clinical trials, all of which were new drug clinical trials.

Note: Due to the presence of ties, the above ranking may include more than 10 items.

Analysis of Drug Clinical Trial Institutions

In the CDE drug clinical trial registration announcement in March 2026,"Peking University First Hospital" Ranks First with 13 Leading Clinical Trials, and the majority of these 13 clinical trials are new drug clinical trials.

"Peking University Cancer Hospital" ranked second with leading 11 clinical trials, all of which were for new drug clinical trials.More detailed information,Please see the figure below for details.Or visitPharmaceutical Intelligence Enterprise Edition [Clinical Trials in China】DatabaseConduct an inquiry.

Note: Due to the presence of ties, the above ranking may include more than 10 entries.

Distribution of Clinical Trial Provinces

In the CDE drug clinical trial registration public announcement in March 2026, the distribution of clinical trial provinces by region of the sponsor organization is shown in the figure below.Jiangsu Ranks First with 104 Clinical Trial Registrations, Shanghai and Beijing rank second and third respectively. For more details, please see the figure below or visitPharmcube Data Enterprise Edition [Clinical Trials in China】DatabaseConduct an inquiry.

Key Events in Clinical Trials

1. TVAX-008 (Therapeutic Hepatitis B Vaccine) Completes First Patient Enrollment in Phase III Clinical Trial

TVAX-008: A Novel Therapeutic Vaccine for "Functional Cure" of Chronic Hepatitis B (CHB)

2. εPA-44 was classified as a Category 1 therapeutic biological product by the NMPA, representing a therapeutic hepatitis B vaccine based on a different technological approach.

The drug focuses on optimizing antigen presentation efficiency in its structural design, with the aim of inducing a stronger and more durable specific immune response in vivo. On March 24, the clinical trial application (IND) for its new indication was officially accepted by the NMPA.

Clinical Data Support and Future Prospects: In the previously completed Phase II clinical trial, εPA-44 demonstrated encouraging efficacy signals in a specific cohort of chronic hepatitis B patients, particularly showing potential in significantly reducing or even clearing HBsAg titers in some patients. This application for a new indication usually implies that the company will further explore the drug's efficacy boundaries among different subgroups of hepatitis B patients (such as HBeAg-negative/positive patients, patients with low-level viremia, etc.) based on prior data, or investigate combination therapy regimens with existing direct-acting antiviral drugs (DAAs) to expand the population benefiting clinically.

3. Harbour BioMed/Kelun Biotech: Long-acting bispecific antibody HBM7575/SKB575 (Atopic Dermatitis) IND Approved, Set to Launch Clinical Trial in China for Moderate to Severe Atopic Dermatitis (AD)

Differentiated Advantages and Clinical Significance: The competition in the AD biologics field is currently fierce (e.g., multiple blockbuster drugs targeting IL-4Rα and IL-13 are already on the market). The clinical advantages of this bispecific antibody lie in: firstly, by blocking upstream signals of multiple inflammatory cascades, such as TSLP, through a dual-target mechanism, it has the potential to cover a broader range of inflammatory phenotypes, addressing the issue of inadequate response to existing monoclonal antibodies in some patients; secondly, its "long-acting" design aims to extend the dosing frequency from the standard every two weeks to once a month or even once a quarter, significantly improving patient compliance. The approval of this IND marks the official entry of this highly commercially promising autoimmune bispecific antibody into the human proof-of-concept stage.

Data Source:Pharmaceutical Intelligence Data - Global/China Clinical Trial Database, Clinical Research Analysis System

PS：Reply to the Yaoke Data WeChat Official Account backend【Clinical 2026], ObtainFull Report PDF Version。

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Editorial Responsibility | Xiao Er

Typesetting Design | Xiao Bai

Reprint Authorization | Teacher Chen 17308362010 (Same as WeChat)

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