Recently, the website of the Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA) of China announced that LM-302, a Class 1 new drug independently developed by LaNova Medicines, a wholly-owned subsidiary of Sino Biopharm (1177.HK), has been included in the Breakthrough Therapy Designation (BTD) program. The indication is for first-line treatment of CLDN18.2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in combination with Toripalimab. LM-302 was first granted Breakthrough Therapy Designation by the CDE in 2023 and has received Investigational New Drug (IND) approval and Orphan Drug Designation (ODD) from the US FDA for pancreatic carcinoma, bile duct cancer, and gastric and gastroesophageal junction cancer.

LM-302 is an Antibody-Drug Conjugate (ADC) targeting Claudin 18.2 (CLDN18.2). It specifically binds to CLDN18.2-positive tumor cells, is internalized, and then releases a small molecule toxin to achieve precise killing of tumor cells. As a potential First-in-Class (FIC) drug, LM-302 has shown clinical potential in the treatment of gastric cancer, pancreatic carcinoma, and biliary tract cancer, and is expected to expand new treatment options for patients with low expression of CLDN18.2 and PD-L1.

At the American Society of Clinical Oncology (ASCO) annual meeting of this year, LaNova Medicines announced the latest research results for LM-302 combined with Toripalimab for the treatment of gastric cancer: among 41 efficacy-evaluable patients, the ORR was 65.9% and the DCR was 85.4%. Among 32 patients with CLDN18.2 expression ≥25%, the ORR was 71.9% and the DCR was 96.9%. Among these, patients with PD-L1 CPS <1 had an ORR of 63.3%, while patients with CPS ≥1 had an ORR of 77.8%. The study results showed that the LM-302 combination regimen has good anti-tumor activity and manageable safety in CLDN18.2-positive patients^[1].

LM-302 is currently undergoing a Phase III clinical trial in China for the treatment of patients with CLDN18.2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have progressed after two or more prior lines of systemic therapy. Its R&D progress ranks among the top three globally for drugs with the same target. The inclusion of this LM-302 combination therapy in the Breakthrough Therapy Designation program is expected to accelerate the review and marketing process for the first-line gastric cancer combination therapy, bringing innovative treatment options to more patients with CLDN18.2-positive gastric cancer sooner.

LM-302 was developed from LaNova Medicines' new-generation Antibody-Drug Conjugate platform (LM-ADC), for which it holds full independent intellectual property rights. This platform focuses on high-value, validated targets, exploring FIC or BIC opportunities within the ADC modality, and covers multiple cancer types, including digestive tract cancer, lung cancer, colorectal cancer, breast cancer, ovarian cancer, and cervical cancer. LM-ADC, together with LaNova Medicines’s proprietary development platforms – including the tumor microenvironment-specific antibody development platform (LM-TME), the antibody development platform for difficult-to-drug targets (LM-Abs), and the T-cell Engager platform (LM-TCE) – forms the cornerstone of the company’s innovative drug discovery arsenal.

These platforms continuously output high-value and high-potential novel molecules, leveraging the robust resources and translational capabilities of Sino Biopharm to accelerate the development and commercialization of groundbreaking therapies. This enables Sino Biopharm to bring more high-potential innovative drugs to the clinic and market more efficiently, ultimately benefiting a broader patient population.

References:

[1]Haiping Jiang,Mingzhu Huang,et al.Efficacy and safety of LM-302 (anti-claudin 18.2 ADC) in combination with anti-PD-1 therapy for advanced gastric, gastroesophageal junction cancer and esophageal adenocarcinoma: Early-phase study results.ASCO 2025

Declaration:

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Forward-Looking Statements:

This press release contains certain forward-looking statements, including statements regarding the clinical development plans for [LM-302], expectations of clinical benefits and advantages, commercialization outlook, the likelihood of clinical benefit for patients, and potential commercial opportunities. Words such as "expect", "believe", "continue", "may", "estimate", "hope", "intend", "plan", "potential", "predict", "project", "should", "will", "propose", and similar expressions are intended to identify forward-looking statements, but not all forward-looking statements contain these identifying words. These forward-looking statements are predictions or expectations made by the company based on currently available data and information, and actual results may differ materially from these forward-looking statements due to uncertainties or risks such as policy, R&D, market, and regulatory factors. Current or potential investors are advised to carefully consider the potential risks and should not place undue reliance on the forward-looking statements in this press release, which contain information only as of the date of this press release. Unless required by law, the company undertakes no obligation to update or revise any forward-looking statements in this press release as a result of new information, future events, or other circumstances.