Minghui Pharmaceutical has announced a strategic partnership with Qilu Pharmaceutical, granting exclusive rights for the development, manufacturing, and commercialization of its B7-H3 targeted antibody-drug conjugate (MHB088C) in Greater China. The agreement, announced on May 9, 2025, covers mainland China, Hong Kong, Macau, and Taiwan.
Under the terms of the deal, Qilu will pay Minghui up to 1.345 billion RMB (approximately $210 million USD), including an upfront payment and near-term milestone of 280 million RMB. The agreement also includes 1.065 billion RMB in development, regulatory, and sales milestone payments, plus double-digit royalties on net product sales. Minghui will retain global rights to MHB088C outside the Greater China region.
Novel B7-H3 ADC Technology
MHB088C is developed using Minghui's proprietary SuperTopoi™ ADC platform and targets B7-H3, a promising oncology target expressed across multiple solid tumors. The drug candidate has demonstrated potent anti-tumor activity with a superior safety profile compared to other ADCs in its class.
"MHB088C has demonstrated robust efficacy with great safety profiles, with no major hematological toxicity or ILD [interstitial lung disease], positioning the program as a best-in-class B7-H3 ADC," said Dr. Guoqing Cao, CEO of Minghui Pharmaceutical.
The favorable toxicity profile is particularly noteworthy as hematological toxicities and ILD have been limiting factors for several other ADC programs in clinical development.
Clinical Development Progress
The B7-H3 ADC has already been evaluated in over 300 patients with advanced or metastatic solid tumors in ongoing Phase I/II clinical trials. These studies have yielded promising efficacy data alongside the favorable safety profile mentioned by company leadership.
Subgroup analyses from these trials will be presented at the upcoming American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, with data in small cell lung cancer (SCLC) featured as an oral presentation and results in metastatic castration-resistant prostate cancer (mCRPC) presented as a poster.
Building on these early results, Minghui has officially initiated a Phase III trial in relapsed SCLC in China, with patient enrollment expected to begin within weeks. This rapid advancement to late-stage clinical development signals confidence in the drug's potential.
Strategic Significance
For Minghui, a late-stage clinical biopharmaceutical company focused on oncology and autoimmune diseases, this partnership represents a significant milestone in its global development strategy.
"Our collaboration with Qilu marks a significant milestone in Minghui's commitment to advancing innovative cancer therapies," Dr. Cao stated. "With Qilu's leadership and resources, we are confident that MHB088C will serve patients in need and contribute to the advancement of precision oncology in China."
Qilu Pharmaceutical brings substantial resources to the partnership as one of China's leading pharmaceutical companies. Established in 1958, Qilu currently ranks among the top three pharmaceutical companies in China for 2024, with 12 subsidiaries, 11 domestic manufacturing sites, and over 36,000 employees worldwide.
Market Context
The deal comes amid growing interest in ADC technologies, which combine the targeting precision of monoclonal antibodies with potent cytotoxic payloads. The ADC market has seen several multi-billion dollar deals in recent years as pharmaceutical companies race to secure promising candidates.
B7-H3 (CD276) has emerged as a particularly attractive target for ADC development due to its limited expression in normal tissues but high prevalence across multiple tumor types, including lung, prostate, pancreatic, ovarian, and breast cancers.
For patients in Greater China, this partnership could accelerate access to a potentially important new therapy for difficult-to-treat cancers like SCLC, which has historically had limited treatment options and poor outcomes after first-line therapy.
The companies have not disclosed a timeline for potential regulatory submissions, but the initiation of Phase III trials suggests that applications could be filed within the next 2-3 years if the data continue to be positive.
