Huadong Pharmaceutical (000963.SZ): Application for HDP-101 (HDM2027) clinical trial developed in collaboration with Heidelberg Pharma in China and US was approved

Zhitong Financial App News, Huadong Pharmaceutical (000963.SZ) issued an announcement. Recently, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as “China-US Huadong”), a wholly-owned subsidiary of the company, received the “Drug Clinical Trial Approval Notice” (Notice Number: 2024LP02317) approved and issued by the National Drug Administration (NMPA). The HDP-101 (hereinafter referred to as “Heberg Pharmidela”) was developed in collaboration with the company's German shareholding company Heidelberg Pharma AG (hereinafter referred to as “Heberg Pharmidela”) (HDM2027) Clinical trial application approved.

According to reports, HDP-101 (HDM2027) is a novel ADC (Antibody-Drug Conjugates, Antibody-Conjugate Drug) drug formed by conjugating a humanized anti-BcMA antibody with a mushroom toxin α-amoscarinic peptide derivative. HDP-101 kills plasma cells by specifically binding to and internalizing the BCMA protein of plasma cells (Plasmacell, PC), thereby achieving the transport of cytotoxic payloads.

The HDP-101 was developed by Heidelberg Pharma, Germany. In February 2022, Huadong Pharmaceutical Investment Holdings (Hong Kong) Co., Ltd., a wholly-owned subsidiary of the company, reached an equity investment agreement with Heidelberg Pharma and obtained a total of 35% of Heidelberg Pharma's shares and became its second largest shareholder; the wholly-owned subsidiary, China and US Huadong reached an exclusive product licensing agreement, and China and US Huadong obtained 2 products under development, including HDP-101, in mainland China, Hong Kong SAR, Macau SAR, Taiwan, South Korea and Southeast Asia Exclusive licenses in 20 Asian countries and regions, including exclusive development and commercialization rights.

Currently, HDP-101 is in clinical development and has not been approved for marketing in any country. This product has been approved by the US FDA and regulators in Poland, Hungary and Germany to conduct a phase 1/2a clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and efficacy of HDP-101 in patients with plasma cell diseases, including multiple myeloma. The first patient administration of this clinical study was completed on February 15, 2022. Furthermore, on March 27, 2024, the FDA granted HDP-101 orphan drug certification (ODD) for the treatment of multiple myeloma.

In August 2024, the HDP-101 China clinical trial application submitted by Huadong China and Heidelberg Pharma was accepted, and recently approved by the NMPA, agreeing to conduct clinical research on this product in China.

The approval of the HDP-101 (HDM2027) clinical trial in China is an important milestone in the product development process and will further enhance the company's core competitiveness in the field of cancer treatment.