Minghui Pharma and Qilu Pharma Advance B7-H3 ADC MHB088C into Phase III Trial Following $1.85B Licensing Deal

Jun 21, 2025 08:17 CST Updated 08:17

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

Recently, Minghui Pharmaceutical Ltd. has developed an innovativeB7-H3 Targeted Antibody-Drug Conjugate MHB088C Officially Launched in China for RefractorySmall Cell Lung Cancer(III-Phase Registration Clinical Trial for SCLC)（CTR20250586）。

May 9, 2025Minghui Pharmaceutical Ltd. and Qilu Pharmaceutical Co., Ltd. Reach Exclusive Licensing Agreement for MHB088C Worth 1.345 Billion RMB, marking another milestone in China's ADC field.

MHB088C is an innovative B7-H3-targeted antibody-drug conjugate developed by Minghui Pharmaceutical Ltd. based on its proprietary SuperTopoi™ ADC technology platform, demonstrating enhanced tumor-killing efficacy and improved safety, significantly broadening the therapeutic window.

According to the results of a Phase I/II study presented at the 2024 ASCO Annual Meeting, MHB088C demonstrated efficacy in 31 evaluable patients with small cell lung cancer (SCLC).ORR was 61.3%, DCR was 93.5%.Among 10 patients treated with a dose of 1.6mg/kg Q2W, the ORR was 80% and the DCR was 90%. Additionally, among 7 evaluable patients with esophageal squamous cell carcinoma, the ORR was 42.9% and the DCR was 85.7%.

Notably, the subgroup analysis results of MHB088C in treating relapsed extensive-stage small cell lung cancer (ES-SCLC) and metastatic castration-resistant prostate cancer (mCRPC) were selected for oral and poster presentations at the 2025 ASCO Annual Meeting. Dr. Guoqing Cao stated, "MHB088C has demonstrated robust efficacy and excellent safety, with no major hematological toxicity or interstitial lung disease."

Currently, no B7-H3 ADC products have been approved for marketing globally. There are four pipelines that have entered Phase III clinical trials, three of which are from China: Minghui Pharmaceutical's MHB088C (for recurrent small cell lung cancer), Yilian Biologics' YL201, and Hansoh Pharma's HS-20093, showing a favorable competitive landscape.

Global B7-H3 ADC Pipeline with Rapid Clinical Progress

SourcePharmCube, Innovation in Medicine

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