Huadong Medicine's Subsidiary Doral Biologics Receives NMPA Approval for DR30206 Clinical Trial in Advanced or Metastatic Gastrointestinal Cancers

Apr 08, 2025 08:32 CST Updated 08:32

Huadong Medicine

Large Comprehensive Pharmaceutical Product Developer

Doer Biologics

Biological Drug Developer

On April 3, 2025, Huadong Medicine Co., Ltd. (hereinafter referred to as "the Company") announced that its controlled subsidiary, Zhejiang Doer Biologics Co., Ltd. (hereinafter referred to as "Doer Biologics"), received the "Clinical Trial Approval Notice" issued by the National Medical Products Administration (NMPA). The clinical trial application for DR30206 Injection in combination with standard chemotherapy for patients with advanced or metastatic gastrointestinal tumors, submitted by Doer Biologics, has been approved. This marks the second approved clinical indication for DR30206, aiming to evaluate the safety, tolerability, and preliminary efficacy of DR30206 in combination with standard chemotherapy regimens in gastrointestinal tumors.

DR30206 for Injection is a Class 1 therapeutic biologic independently developed by Doer Biologics with global intellectual property rights. DR30206 is an antibody fusion protein targeting PD-L1, VEGF, and TGF-β. By blocking the PD-1/PD-L1 signaling pathway, it restores the proliferation of exhausted CD8+T cells. Through specific binding to free VEGF and TGF-β, it reduces the formation of tumor neovasculature while alleviating immunosuppression, thereby achieving anti-tumor effects. Completed non-clinical studies and ongoing Phase I clinical trial results indicate that DR30206 has a clear mechanism of action and tumor growth inhibition, with good safety, supporting the initiation of clinical trials combining DR30206 with standard chemotherapy in patients with advanced or metastatic gastrointestinal tumors.

To date, there is no antibody fusion protein drug targeting PD-L1, VEGF, and TGF-β simultaneously available on the global market. The approval of the clinical trial in China for DR30206 Injection combined with standard chemotherapy for patients with advanced or metastatic gastrointestinal tumors marks another significant advancement in the development of this novel drug.

In the future, the company will adhere to the corporate philosophy of "research-based and patient-centered," continue to fully advance the clinical and registration work of this product, and strive to provide more treatment options for clinical patients. Relying on the company's existing R&D platform, it will increase investment in innovative drug R&D, continuously enrich the innovative pipeline, and ultimately achieve differentiated positioning and leading market competitiveness in the field of innovative drugs.

Statement

1. This news aims to share the frontier progress of the company's (or partners') R&D work, not for advertising purposes. The relevant information is not targeted at patients and is only for reference by healthcare professionals.

2. The content in this press release does not involve any recommendation for any drug and/or indication;

3. The information involved in this press release is for reference only, and the specific information shall be subject to the documents published by the company on the Shenzhen Stock Exchange. The company's press releases and announcements cannot replace professional medical guidance in any way and should not be regarded as medical treatment advice. If you wish to learn specific disease diagnosis and treatment information, please follow the advice or guidance of doctors or other healthcare professionals.

4. As of the publication of this article, DR30206 has not been approved for marketing by the National Medical Products Administration;

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