February 24, 2022 - Euho Pharma, a wholly-owned subsidiary of Biositu, as a biopharmaceutical company dedicated to the development of antibody drugs with independent intellectual property rights, announced today that the China National Medical Products Administration (NMPA) has approved its IND application for the Phase I clinical trial of the innovative anti-CD40 monoclonal antibody YH003, anti-CTLA-4 monoclonal antibody YH001 combined with anti-PD-1 pembrolizumab humanized monoclonal antibody injection.

NMPA Approves Euho Pharma to Conduct a Phase I International Multicenter Clinical Research Trial in China: Safety, Tolerability and Pharmacokinetics of a Combination of YH003, YH001 and Pembrolizumab in Subjects with Advanced Solid Tumors A multicenter, open-label, phase I dose-escalation study of the drug (protocol number: YH003005). The study is an international multi-center clinical trial, and participating countries include Australia and China. The trial had previously been approved by Australian regulators.

The Phase I dose escalation study of YH003 combined with toripalimab in subjects with advanced solid tumors in Australia (protocol number: YH003002) evaluated the safety, tolerability, pharmacokinetics and preliminary results of YH003 antitumor efficacy. YH003 combined with toripalimab showed good safety and tolerability. Of the 20 patients enrolled in the group, 2 patients had grade 3 AEs related to YH003, which were neutropenia and elevated transaminases. . One DLT event was observed in all subjects, no drug-related SAE occurred, and no death due to AE occurred. YH003 in combination with toripalimab demonstrated preliminary antitumor activity in subjects with advanced solid tumors. Of the 13 radiographically evaluable subjects, 2 were PR and 3 were SD.

The clinical phase I dose escalation study of YH001 combined with toripalimab in subjects with advanced solid tumors in Australia (protocol number: YH001002) evaluated the safety, tolerability and pharmacokinetic characteristics of YH001 and preliminary antitumor efficacy. Twenty-four patients with advanced solid tumors were included in the study, and YH001 combined with toripalimab showed good tolerability and safety. Drug-related adverse events were predominantly grade 1 (22) and grade 2 (19), with grade 3 and higher adverse events being isolated (2). No dose-limiting toxicity (DLT) has been observed to date. YH001 combined with toripalimab demonstrated exciting antitumor activity in subjects with advanced solid tumors, with 3 PRs and 7 SDs.

In this regard, Dr. Shen Yuelei, CEO of Euho Pharma, said, "The NMPA approval of the Phase I clinical trial of the three-drug combination YH001, YH003 and pembrolizumab is a milestone for Euho Pharma. After the approval to carry out the Phase II clinical study in combination with PD-1, we were approved by the Chinese Food and Drug Administration to carry out the Phase I clinical study of the three-drug combination, which is an affirmation of the clinical safety and preliminary efficacy of YH001 and YH003.

We are very pleased that the Yoho team can advance clinical progress so efficiently, and we will continue to actively promote the clinical trials of YH001 and YH003 in China and around the world. As the follow-up Biositu Qianmu Antibiotics program continues to enrich the clinical pipeline of Euho, we will gradually involve in the first-in-class field, and we are confident that Bioset, including Euho, will become a global new drug in the near future. an important role in R&D.

About YH003

YH003 is a humanized IgG2 agonistic antibody targeting CD40. It specifically binds to the CD40 receptor, promotes the activation of antigen-presenting cells, and positively regulates the effector activity of anti-tumor T cells. Studies to date have shown that CD40 activation is a key regulatory point in tumor immunotherapy, which can effectively convert cold tumors lacking immune cell infiltration into hot tumors that respond well to tumor immunotherapy. In the preclinical antibody screening stage, Euho Pharma made full use of the tumor model in CD40 humanized mice independently developed by Biocytos, and quickly screened in mice to completely inhibit tumor growth without side effects such as hepatotoxicity. cloned antibodies.

Whether used alone or in combination with anti-PD-1 monoclonal antibodies, YH003 has shown strong anti-tumor effects on a variety of tumor models in mice. Pharmacodynamic studies in mice showed that YH003 significantly increased the proportion of anti-tumor T cells in tumor-infiltrating cells. Importantly, YH003 showed good safety even at very high doses, both in mice and monkeys.

About YH001

YH001 is an anti-CTLA-4 monoclonal antibody that enhances the body's own immune response against tumor cells by enhancing the removal of regulatory T cells (Treg) in the tumor microenvironment, thereby achieving the purpose of treating various tumors. By blocking the inhibitory signal of the human anti-tumor response to enhance the patient's immune response to the tumor, it is considered to be the most promising tumor immunotherapy. CTLA-4 and PD-1 are considered two important checkpoints of the immune system, blocking them can affect different types of T cells to initiate anti-tumor immune attacks, and these two checkpoints are also considered to be tumor immune The cornerstone of therapy.

About Euho Medicine

As a wholly-owned subsidiary of Bioset, Euho Pharma undertakes the mission of clinical development for Bioset's R&D pipeline. Relying on a strong clinical development team and rich clinical development experience, Euho Pharma develops drugs that meet clinical needs for patients in China and around the world. innovative medicines. Biocyto focuses on tumor and non-tumor antibody drug therapy, and has built a strong R&D pipeline targeting more than ten targets. At this stage, two products have started international multi-center (MRCT) phase II clinical research, and two products are in clinical phase I.

For details, please visit: www.eucure.com

About Biositu

Biositu is an international biopharmaceutical company with innovative technologies driving new drug research and development. Based on the fully human antibody RenMice platform (RenMab® and RenLite® mice) independently developed and owned by Biocytos, the monoclonal antibody and double antibody development technology platform, animal in vivo drug efficacy screening platform, and strong clinical development capabilities Organically integrated, it has formed a unique new drug research and development capability covering the whole process of drug research and development. Biositu is conducting large-scale drug development for more than 1,000 druggable targets (the "Qianmuwananti-TM" plan). 14 companies including a number of MNCs have reached authorization cooperation on the RenMice platform. In the future, Biositu will continue to work with global partners to continuously produce many First-in-class and Best-in-class antibody drugs to better benefit patients. Biositu is headquartered in Beijing, with branches in Haimen, Jiangsu, Boston, Shanghai and other places.