GlaxoSmithKline Acquires Exclusive Licensing Rights for Johnson Pharmaceuticals' Promising ADC Drug HS-20089: A Potential Breakthrough Therapy for Gynecologic Cancers

Recently, GlaxoSmithKline (GSK) announced on its official website that it has reached an exclusive licensing agreement with Johnson Pharmaceuticals for HS-20089.

According to the licensing agreement and its terms and conditions, Johnson Pharmaceuticals will receive an upfront payment of $85 million and is eligible for milestone payments of up to $1.485 billion based on achievement.

Under the agreement, GSK will obtain global exclusive licenses (excluding mainland China, Hong Kong, Macau, and Taiwan) to advance the development and commercialization of HS-20089.

After the commercialization of HS-20089, GSK will also pay tiered royalties on net sales outside mainland China, Hong Kong, Macau, and Taiwan.

HS-20089: A Potential BIC (Best-in-Class) Candidate

HS-20089 is a novel B7-H4 targeted antibody-drug conjugate (ADC) with a topoisomerase inhibitor (TOPOi) payload. B7-H4 is a transmembrane glycoprotein in the B7 superfamily, which is expressed at limited levels in normal tissues but highly expressed in various cancers. It is currently undergoing a Phase I clinical study for gynecologic tumors in China (NCT05263479).

Hesham Abdullah, Senior Vice President and Head of Global Oncology R&D at GSK, stated that based on early clinical data, GSK believes that HS-20089 has the potential to be best-in-class for ovarian cancer, endometrial cancer, and other solid tumors. The agreement aligns with GSK's strategy of developing new treatment options for female gynecologic cancer patients.

In addition to targeting the B7-H4 surface antigen, which is overexpressed in ovarian and endometrial cancers and is typically associated with poor prognosis, HS-20089 utilizes the clinically validated ADC technology of topoisomerase inhibitors (TOPOi) as the payload. TOPOi is a validated ADC technology that has been used in approved anticancer drugs as the standard treatment for breast and ovarian cancers.

Ms. Sun Yuan, Executive Director of the Board at Johnson Pharmaceuticals, stated that Johnson is committed to providing first-in-class or best-in-class drugs to fulfill unmet medical needs. Johnson is delighted to further develop HS-20089 and provide a breakthrough therapy for cancer patients. The expertise of GSK in developing therapies for gynecologic cancers and its commercial footprint make it an ideal partner to bring HS-20089 to patients outside of China.

This agreement builds upon GSK's strategic focus on tumor cell targeting modalities and its significant medical and commercial expertise in gynecologic cancers. HS-20089 complements GSK's portfolio of oncology products and strategic disease areas, including potential future combinations.

GSK plans to conduct a Phase I clinical trial for HS-20089 outside of China in 2024.

Frequent ADC Deals with Potential Overseas Licensing

Optimistic Outlook for Overseas Licensing Potential

There have been multiple ADC drug deals both domestically and internationally this year, with nearly 10 overseas licensing deals in China alone. This demonstrates industry recognition of the future potential of ADC drugs. Considering that domestic companies are already leading the industry in the layout of ADC targets, there is great potential for overseas licensing.

Alongside GSK's announcement of acquiring Johnson Pharmaceuticals' ADC drug HS-20089, Merck and Taiho Pharmaceutical jointly announced their collaboration to develop three ADC projects and potentially commercialize them globally, with Taiho retaining rights in Japan. The three ADC projects are patritumab deruxtecan (HER3 ADC), ifinatamab deruxtecan (B7H3 ADC), and raludotinib deruxtecan (CDH6 ADC).

Merck will make an upfront payment of $4 billion to Taiho, followed by additional payments of $1.5 billion within the next 24 months. Furthermore, Merck will pay up to $5.5 billion in commercial milestone payments for each ADC. The total agreement value amounts to $22 billion.

On October 12th, Innovent Biologics announced a strategic collaboration and global licensing agreement with BioNTech to jointly develop the next-generation ADC targeting human epidermal growth factor receptor 3 (HER3). Under the agreement, Innovent will grant BioNTech exclusive rights to develop, manufacture, and commercialize one of its ADC products globally (excluding mainland China, Hong Kong, and Macau). BioNTech will make an upfront payment of $70 million to Innovent, as well as additional development, regulatory, and commercialization milestone payments totaling over $1 billion.