Breakthrough in Domestic Anti‑Influenza New Drug! Leadingpharm · Deep Blue Ocean Supports Approval of Jikeshu® Adolescent Indication

Recently, the adolescent indication for the Class 1 anti‑influenza new drug Maseloxavir Tablets (trade name: Jikeshu®), developed by Zhengxiang Pharmaceutical (Nanjing) Group Co., Ltd., has been officially approved by the National Medical Products Administration (NMPA).
 

The approval for the adolescent influenza indication is based on a multicenter, randomized, double‑blind, placebo‑controlled Phase III clinical study, led by Professor Zhang Wenhong and Professor Zhang Jing from Huashan Hospital, Fudan University, and Professor Chen Zhimin from the Children’s Hospital, Zhejiang University School of Medicine, with Leadingpharm · Deep Blue Ocean serving as the contract research organization (CRO) responsible for its implementation.
 

With this approval, Jikeshu® expands from adult use to adolescents aged 12 and above, further completing its age‑coverage in influenza treatment and offering a more convenient and effective new option for adolescent patients. The study met its primary and secondary efficacy endpoints with significant clinical benefits. Notably, this is the only large‑scale Phase III trial among anti‑influenza PA inhibitors conducted specifically for adolescent influenza, providing more robust evidence for clinical medication choices in this population.
 

Study results showed that in adolescent patients with influenza A and B, Jikeshu® significantly shortened the time to symptom relief, with a median time of 52 hours versus 82 hours in the placebo group. The time to viral RNA negativity was only 48 hours in the treatment group, a nearly 60% reduction compared to 111 hours in the placebo group, substantially lowering the risk of viral transmission. Additionally, Jikeshu® demonstrated notable relief for the three common respiratory symptoms (nasal congestion, sore throat, cough), with a median relief time of 48 hours versus 76 hours for placebo, achieving full relief one day earlier. In terms of safety, Jikeshu® was well tolerated, with overall TEAE rates comparable to placebo, no gastrointestinal adverse reactions, further confirming its excellent safety profile.
 

As the CRO for the Phase III adolescent study of Jikeshu®, Leadingpharm · Deep Blue Ocean is honored to have been deeply involved in and witnessed this milestone for a domestic innovative drug. In an increasingly competitive environment for innovative drug R&D, Leadingpharm · Deep Blue Ocean will continue to excel in the clinical field, leveraging its nationwide clinical resource network, mature project management experience, and internationally aligned quality standards to work alongside more outstanding innovative drug companies, ensuring that innovative outcomes truly benefit every patient.
 

About Us

Deep Blue Ocean Biopharmaceutical is the clinical CRO sub‑brand of Leadingpharm (stock code 600222), established in 2007. Adhering to the philosophy “End‑to‑End, Top‑Level Design, Being the Full‑Process Partner for New Drug Development,” it provides global pharmaceutical companies with services covering Phase I‑III clinical studies, bioequivalence studies, third‑party auditing, IND application strategy guidance, and medical affairs for biologics, chemical drugs, TCM, medical devices, and cell & gene therapies. It meets the customized clinical research needs of various R&D‑oriented companies and helps clients overcome key bottlenecks before new drug launch.
 

To date, the company has conducted over 2,000 clinical research projects. In cell & gene therapy and aesthetic medicine, multiple projects have achieved domestic/international first‑in‑human or first‑approved status, filling gaps in China and globally. It also possesses extensive experience and resource accumulation in endocrinology, cardiovascular, oncology, rheumatology & immunology, pediatrics, rare diseases, and neuropsychiatry.

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