Minghui and Qilu Form Partnership for B7-H3 ADC Development in Greater China

In a significant development, Minghui Pharmaceutical, a biopharmaceutical company in its late clinical stages, has announced a strategic licensing and collaboration agreement with Qilu Pharmaceutical. This agreement focuses on the development, manufacturing, and commercialization of an innovative cancer therapy, the B7-H3 antibody-drug conjugate (ADC), identified as MHB088C, within the Greater China region. This region encompasses Mainland China, Hong Kong, Macau, and Taiwan.

Under this partnership, Qilu Pharmaceutical will receive exclusive regional rights to MHB088C, while Minghui is set to benefit from a series of payments amounting to a total of 1.345 billion RMB. This figure includes an upfront payment of 280 million RMB along with an impending milestone payment. Additionally, further payments based on developmental, regulatory, and sales milestones could reach up to 1.065 billion RMB. Minghui will also continue to receive royalties based on the net sales of the product within the designated region. However, Minghui retains the global rights to MHB088C beyond Greater China and will continue to advance its development in those areas.

MHB088C represents a novel approach in cancer therapy, being a B7-H3-targeted ADC crafted from Minghui's proprietary SuperTopoi™ ADC platform. This ADC is noted for its strong anti-tumor efficacy and commendable safety profile, which broadens the therapeutic window significantly. In clinical trials, MHB088C has been administered to over 300 patients with advanced or metastatic solid tumors, showing a promising safety profile and efficacy. These trials, classified as Phase Ⅰ/Ⅱ, highlighted the drug's potential, with findings in specific cancer subgroups, namely small cell lung cancer (SCLC) and metastatic castration-resistant prostate cancer (mCRPC), set to be presented at the upcoming ASCO 2025 Annual Meeting. Furthermore, a Phase Ⅲ trial focusing on relapsed SCLC has been initiated in China, with patient enrollment commencing soon.

Dr. Guoqing Cao, the CEO of Minghui, emphasized the significance of the collaboration with Qilu Pharmaceutical as a pivotal advancement in Minghui's mission to pioneer innovative cancer treatments. He highlighted the impressive efficacy and safety of MHB088C, noting the absence of serious hematological toxicity or interstitial lung disease (ILD), which positions it as a leading B7-H3 ADC candidate. Dr. Cao expressed confidence in Qilu's leadership and resources to support the success of MHB088C in aiding patients and pushing forward precision oncology in China.

Minghui Pharmaceutical is recognized for its dedication to developing groundbreaking medicines to address unmet medical needs in oncology and autoimmune diseases. With a strong foundation in medical science and proprietary technology, Minghui has established a diverse pipeline of clinical-stage programs, including advanced ADCs and a PD-1xVEGF bispecific antibody. The company is relentlessly pursuing therapies that significantly improve patient outcomes globally.

Qilu Pharmaceutical, established in 1958, has grown into one of China’s leading pharmaceutical entities. It is renowned for its vertically integrated operations, encompassing the development, manufacture, and distribution of both Finished Dosage Forms (FDFs) and Active Pharmaceutical Ingredients (APIs). With 12 subsidiaries and 11 manufacturing sites in China, Qilu employs over 36,000 individuals worldwide. The company has a robust product portfolio and has consistently launched innovative and generic pharmaceuticals, enhancing healthcare standards globally.