YouHealth Pharma Receives NMPA Approval for Phase II International Multicenter Clinical Trial of Anti-CD40 Monoclonal Antibody YH003

On November 1, 2021, Eucure, a wholly-owned subsidiary of Biocytogen and a biopharmaceutical company dedicated to the independent development of antibody-based drugs with proprietary intellectual property rights, announced that the China National Medical Products Administration (NMPA) had approved its Investigational New Drug (IND) application for the Phase II international multicenter clinical trial of YH003 (a humanized anti-CD40 monoclonal antibody injection).

NMPA Approves Eucure’s Phase II International Multicenter Clinical Trial in China: A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of YH003 in Combination with Toripalimab Injection in Patients with Unresectable or Metastatic Melanoma and Pancreatic Ductal Adenocarcinoma (Protocol No.: YH003004). This international multicenter clinical trial is being conducted in countries including the United States, Australia, and China. Previously, the trial obtained approval from Australian regulatory authorities and hospital ethics committees, as well as clearance from the U.S. FDA, and has been progressing smoothly. Mayo Clinic is currently in the process of initiating participation in this trial for both indications.

The Phase I dose-escalation study conducted in Australia (Protocol No.: YH003003) enrolled a total of 20 subjects. DLT assessments for all dose cohorts have been completed. Two cases of Grade 3 AEs related to YH003 were observed, namely neutropenia and elevated transaminases. One subject experienced a Grade 3 AE related to toripalimab, which was elevated lipase. One DLT event was observed among all subjects. No drug-related SAEs occurred, and there were no deaths due to AEs. Among the 13 subjects evaluable by imaging, 2 achieved PR and 3 had SD.

In response, Dr. Shen Yuelei, CEO of Biocytogen and Eucure, stated, “The approval by the NMPA for the Phase II international multicenter clinical trial of YH003 is a milestone for Biocytogen and Eucure. Following the approvals from the U.S. FDA and Australian authorities for the Phase II international multicenter clinical study of YH003, we have now also received approval from China’s drug regulatory agency, which serves as an endorsement of YH003. We will continue to actively advance the clinical trials of YH003 in China and globally, striving to complete its clinical development as soon as possible and provide patients with new treatment options at the earliest opportunity.”

YH003 is a humanized IgG2 agonistic antibody targeting CD40. By specifically binding to the CD40 receptor, it promotes the activation of antigen-presenting cells and positively regulates the effector activity of anti-tumor T cells. Research to date has shown that CD40 activation is a key regulatory node in tumor immunotherapy, capable of effectively converting "cold" tumors, which lack immune cell infiltration, into "hot" tumors that respond well to tumor immunotherapy. During the preclinical antibody screening phase, Eucure Technology (Beijing) Co., Ltd. fully leveraged tumor models established on Biocytogen’s proprietary CD40-humanized mice to rapidly identify monoclonal antibodies in vivo that completely inhibited tumor growth without causing side effects such as hepatotoxicity. YH003 demonstrated potent anti-tumor efficacy against multiple tumor models in mice, both as a monotherapy and in combination with anti-PD-1 monoclonal antibodies. Mouse pharmacodynamic studies indicated that YH003 significantly increased the proportion of anti-tumor T cells among tumor-infiltrating lymphocytes. Importantly, YH003 exhibited a favorable safety profile in both mice and monkeys, even at high doses.

As a wholly-owned subsidiary of Biocytogen, Eucure is an innovative biotechnology company rooted in China with a global perspective. It focuses on developing innovative antibody drugs with independent intellectual property rights. Leveraging a robust clinical development team and extensive experience, Eucure is committed to developing innovative medicines that meet clinical needs for patients in China and worldwide. Focusing on the field of immunotherapy, Eucure has built a strong R&D pipeline targeting more than ten therapeutic targets. Currently, four of its R&D products have obtained clinical trial approvals in both the United States and China; one product has received Phase II clinical trial approval from both the FDA and the NMPA and has initiated global Phase II trials; another product has received FDA Phase II clinical trial approval and has also launched global Phase II trials; two R&D products have entered Phase I clinical trials in China; and four are undergoing Phase I clinical trials in Australia.

Eucure, a wholly-owned subsidiary of Biocytogen, focuses on clinical development.

Biocytogen is an international biotechnology company driven by innovative technologies for new drug development, committed to becoming a global source of novel therapeutics with the mission of focusing on technological innovation, sustaining the output of new drugs, and safeguarding human health. Leveraging its independently developed RenMice platform (RenMab® and RenLite® mice) with full independent intellectual property rights, Biocytogen has organically integrated its single-cell antibody discovery technology platform, efficient gene-edited model development platform, large-scale animal model supply platform, rapid in vivo and in vitro efficacy evaluation platform, and robust clinical development capabilities. This integration has established a distinctive new drug R&D system covering the entire drug development process. The company has successfully strategically upgraded to a Biotech model, with a future focus on the R&D of innovative antibody drugs. With the implementation of its large-scale antibody drug R&D initiative, the “Thousand Mice, Ten Thousand Antibodies™” plan, Biocytogen will collaborate with global partners to accelerate new drug development. Headquartered in Beijing, Biocytogen has branches in Haimen (Jiangsu), Boston (USA), Shanghai, and other locations. Its wholly-owned subsidiary, Eucure Technology (Beijing) Co., Ltd., specializes in clinical development.