East China Medicine Acquires 75% Stake in Doer Biologics for RMB 487.5 Million; Doer's First-in-Class CLDN18.2-Targeting Antibody DR30303 Files IND

On November 16, the CDE website showed that Doer Biologics' innovative CLDN18.2 antibody DR30303 was submitted for clinical trial for the first time.

From the CDE official website

On April 27 this year, Huadong Medicine announced the acquisition of 75% equity in Zhejiang Doer Biologics Co., Ltd. for 487.5 million RMB, becoming its controlling shareholder. Doer Biologics focuses on developing multi-specific innovative fusion proteins, antibody drugs, and peptide drugs based on multi-domain structures to meet unmet clinical needs in the fields of oncology, metabolism, ophthalmology, and more.

In this transaction, Huadong Medicine acquired Doer Biologics' four major innovative technology platforms and six key products under development, and DR30303 is one of them. This also marks the first IND application submitted by Doer Biologics, signifying the company's transition from preclinical to clinical stage.

DR30303: Targeting CLDN18.2

DR30303 is an antibody drug obtained by screening a single-domain antibody that specifically recognizes CLDN18.2 based on the HTS-VHH Body technology platform and fusing it with human Fc. It has been engineered to enhance the killing effect on CLDN18.2-positive tumor cells through ADCC (antibody-dependent cell-mediated cytotoxicity) and CDC (complement-dependent cytotoxicity). It is clinically intended for the treatment of solid tumors with high CLDN18.2 expression, such as gastric cancer and pancreatic cancer.

Gastric cancer is highly prevalent in East Asian countries. According to the International Agency for Research on Cancer (IARC), a subsidiary of the World Health Organization, there were approximately 480,000 new cases of gastric cancer in China in 2020, accounting for about 10.5% of all new cancer cases throughout the year. Currently, first-line chemotherapy remains the standard treatment, and there are still no effective targeted therapies, representing a strong unmet medical need. Globally, there are no drugs targeting the CLDN18.2 currently on the market.

Based on this, CLDN18.2 is also a highly sought-after important target. According to the Insight database, the layout of domestic companies in this field is very comprehensive, ranging from monoclonal antibodies to bispecific antibodies, from ADCs to CAR-T, covering all types of drugs. Among them, monoclonal antibodies (including antibody fusion proteins) are the most common, with a total of 11 varieties, and DR30303 is the 12th. However, except for Astellas' Zolbetuximab, the highest progress of domestic companies' CLDN18.2 monoclonal antibodies is in Phase I clinical trials; one ADC and one CAR-T have entered Phase II clinical trials, coming from Aosaikang and Carsgen, respectively.

CLDN18.2 Target Competition Details (Insight)

From Insight Database (http://db.dxy.cn/v5/home/)

Doer Biologics: Dual-target/Triple-target Antidiabetic Drugs Are Worth Looking Forward To

Doer Biologics' R&D project layout focuses on the oncology and metabolism fields.

In the field of oncology, the new drug pipeline has developed mono-clonal, bispecific, and trispecific antibody products targeting CLDN18.2, PD-L1, and other targets. Representative new drug projects include DR30303, DR30206, and DR30318.

In the metabolic field, the new drug pipeline focuses on the development of dual-target and triple-target drugs based on GLP-1R, GIPR, and FGF21R targets, including DR10624 (a tri-specific agonist targeting GLP-1R/GCGR/FGFR1c-βKlotho), DR10627 (a dual-specific agonist targeting GLP-1R/GIPR, rapid-acting daily formulation), and DR10628 (a dual-specific agonist targeting GLP-1R/GIPR, long-acting weekly formulation).

Six Key Candidate Drugs from Doer Biologics

Source: Corporate Announcement

In April, when the two companies reached an agreement, Huadong Medicine disclosed that the anti-tumor drug DR30303, the triple-target long-acting hypoglycemic drug DR10624, and the dual-target short-acting hypoglycemic drug DR10627 were planned to apply for clinical trials within 2021. Now that DR30303 has been submitted for clinical trials, it is believed that the other two hypoglycemic drugs will not be far from entering clinical trials.