▎WuXi AppTec Content Team Report

On the evening of October 20, Hansoh Pharma announced that its wholly-owned subsidiary, Shanghai Hansoh Biotechnology, had entered into a licensing agreement with GSK, granting the latter an exclusive global license (excluding mainland China, Hong Kong, Macao, and Taiwan) to develop, manufacture, and commercialize.B7-H4Targeted Antibody-Drug Conjugates (ADC）HS-20089, thisCooperativeUpfront and milestone payments of up to $1.57 billion. This significant collaboration has once again drawn the industry's attention to partnerships in the ADC field.

It is worth mentioning that,Hansoh Pharma was not the first company this year to reach an agreement on ADC."License-out" cooperation with Chinese companies. According to incomplete statistics, since 2023, includingChinese Companies, Including CSPC, DualityBio, BrightGene, LaNova Medicines, and Yilian Biotech, Have Reached Licensing Collaborations on ADC with Overseas Companies. This Article Will Share These Cases for Readers' Reference Only.

Authorizing Party: Hansoh Pharma

Introducing Party: GSK China

Authorized Products:ADC Targeting B7-H4

According to the announcement by Hansoh Pharma, HS-20089 is a novel B7-H4-targeted ADC with a topoisomerase inhibitor (TOPOi) as its payload. B7-H4 is a transmembrane glycoprotein in the B7 superfamily, showing limited expression in normal tissues but high expression across various cancers. The product is currently undergoing Phase 1 clinical trials in China for the treatment of advanced solid tumors.

According to the license agreement and its terms and conditions, Shanghai Hansoh Biologics will receive an upfront payment of 85 million US dollars and is eligible to receive milestone payments of up to 1.485 billion US dollars upon the achievement of related events for this product.After the commercialization of this product, GSK will also pay tiered royalties on global net sales outside mainland China, Hong Kong, Macao, and Taiwan.

Authorizing Party:Yilian Biologics

Introducing Party: BioNTech

Authorized Products:HER3-targeted ADC

October 12, Yilian BiologicsAnnounced a strategic cooperation and global licensing agreement with BioNTech, under which the two parties will collaborate to developNext-Generation ADC Targeting Human Epidermal Growth Factor Receptor 3 (HER3)。According to the terms of the agreement, Yilian Biotechnology will grant BioNTech exclusive rights to develop, manufacture, and commercialize one of its ADC products worldwide (excluding mainland China, Hong Kong, and Macao).BioNTech to Pay Yilian Biotech$70 million upfront payment, as well as additional development, regulatory and commercialization milestone payments,Total potential amount exceeds 1 billion US dollars。

According to the press release from Yilian Biotech, the project for which the licensing collaboration was reached was developed using the company's TMALIN technology. It has demonstrated promising efficacy and safety in various preclinical tumor models. Currently, preliminary clinical data further supports the concept validation of this project.

Authorizing Party: DualityBio

Introducing Party: BioNTech

Authorized Products:Trop2-targeted ADC (DB-1305）

On August 7, Yingen Biotech announced an expansion agreement with BioNTech.Cooperation Agreement, to jointly advance the development, production, and commercialization of the third ADC candidate product, DB-1305, globally (excluding mainland China, Hong Kong, and Macao regions). DualityBio will receive an upfront payment as well as milestone payments based on development, regulatory, and commercial achievements.DB-1305 is a third-generation Trop2 ADC molecule constructed based on the proprietary DITAC platform of DualityBio.。

Authorizing Party: Lemzoparlimab

Introducing Party: AstraZeneca

Authorized Products:ADC Targeting GPRC5D

Indications: Multiple myeloma, etc.

In May 2023, Limin Pharmaceuticals announced a global exclusive licensing agreement with AstraZeneca. According to the terms of the agreement,AstraZeneca will obtain the exclusive global license for the research, development, and commercialization of LM-305, an antibody-drug conjugate targeting GPRC5D, developed by Limin Pharmaceuticals.. Lixun Pharmaceuticals will be eligible to receiveIncluding an upfront payment totaling 55 million US dollars in near-term payments, and potential development and commercial milestone payments of up to 545 million US dollars., as well as tiered royalties on global net sales.

LM-305 is an ADC targeting GPRC5D, consisting of an anti-GPRC5D monoclonal antibody, a protease-cleavable linker, and a cytotoxic payload monomethyl auristatin E (MMAE).GPRC5D is a member of the D subgroup in Group C of the G protein-coupled receptor family. It is highly expressed specifically in multiple myeloma (MM) cells and is hardly expressed in normal tissues. Currently, LM-305 has been approved for clinical trials in the United States and China.Intended for the treatment of multiple myeloma and other plasma cell disorders。

Authorizing Party: Biolysiac

Importer: Eisai

Authorized Products:HER2-targeted ADC

Indications:HER2-positive solid tumors

In May 2023, Biocytogen announced its collaboration with Eisai.（Eisai）A clinical trial cooperation agreement with a strategic partnership option for the subsequent ADC drug BB-1701 of the former has been reached.According to the agreement,Biocytogen and Eisai to Co-develop BB-1701，Belleck will receive an upfront payment and milestone payments.. SupposeEisai Exercises Option for BB-1701 Strategic CooperationBellez Pharmaceuticals will receive the corresponding exercise payment and is also eligible to receive up to $2 billion in development and commercialization milestone payments.and sales sharing,Eisai Obtains Global (Excluding Greater China) Development and Commercialization Rights for BB-1701。

BB-1701 is developed byDeveloped by BelleScon,It is an ADC targeting human epidermal growth factor receptor-2 (HER2) with Eribulin as the toxin., aimed at locally advanced and metastaticPatients with HER2-positive solid tumorsProvide safer and more effective treatment options.

Authorizing Party: EddingPharm

Introducing Party: Pyramid Biosciences

Authorized Products:TROP2-targeted ADC

Indications: Tumor

In April 2023, Pyramid Biosciences announced that it had entered into an exclusive license agreement with Qide Medicine to cover all regions outside of Greater China (Mainland China, Hong Kong, Macao, and Taiwan).Development and Commercialization of Kaitai Pharmaceuticals' TROP2-Targeted Antibody-Drug Conjugate (ADC) GQ1010According to the terms of the agreement, Pyramid Biosciences will develop and commercialize GQ1010.Qide Medicine to Receive $20 Million Upfront Payment and Up to $1 Billion in Additional Milestone Payments, and is eligible for tiered royalties on net sales.

Studies show that TROP2 is highly expressed in many different types of human tumors and plays a significant role in tumorigenesis, progression, and invasion. Antibodies targeting the inhibition of TROP2 can effectively suppress the growth of various tumor cells in animal cancer models and have demonstrated synergistic effects with multiple anti-tumor therapies.GQ1010 utilizes a unique site-specific conjugation technology and incorporates a novel linker-payload, which may enhance the stability, safety, and efficacy of ADCs.Preclinical data indicate that GQ1010 has a wider therapeutic range, which is expected to enhance the efficacy and safety of GQ1010.

Licensor: DualityBio

Introducing Party: BioNTech

Authorized Products:HER2-targeted ADCs, etc.

Indications: Tumor

In April 2023, DualityBio announced an exclusive licensing and collaboration agreement with BioNTech for two ADC candidates, DB-1303 and DB-1311, developed by the former.BioNTech will obtain the rights to develop, manufacture, and commercialize these two ADCs globally (excluding mainland China, Hong Kong, and Macao)., DualityBio will retain the development, production, and commercialization rights in mainland China, Hong Kong, and Macao. As part of the DB-1311 agreement, DualityBio has the option to exercise co-development and co-commercialization rights for the U.S. market in the future. As part of this licensing collaboration,DualityBio will receive an upfront payment totaling $170 million and is eligible to receive development, registration, and commercialization milestone payments exceeding $1.5 billion in total., as well as royalties based on future potential net sales.

DB-1303 is a third-generation ADC product targeting HER2.. It has demonstrated good anti-tumor activity, safety, and a wide therapeutic window in both HER2-positive and HER2-low tumor models. Existing preclinical and early clinical research data all show,DB-1303 has the potential to address unmet medical needs in patients with various HER2-expressing tumors.. Another product in this authorized cooperationDB-1311 is an ADC candidate drug based on a topoisomerase-1 inhibitor.In a series of tumor models representing various cancer types, it has demonstrated favorable anti-tumor activity. Moreover, in preclinical safety evaluations, it has also shown good tolerability and pharmacokinetic characteristics.

Authorizing Party: CSPC Group

Introducing Party: Corbus Company

Authorized Products:Anti-Nectin-4 ADC

Indications: Solid Tumors

On February 13, 2023, CSPC announced that its subsidiary CSPC Jushi Biologics had entered into an exclusive licensing agreement with Corbus Pharmaceuticals.Agreement, granting the latter exclusive rights to develop and commercialize SYS6002 in the United States, the European Union, the United Kingdom, Canada, Australia, Iceland, Liechtenstein, Norway, and Switzerland.Giantstone Biologics of Shijiao will charge$7.5 million upfront payment`, and has the right to collect`Up to US$130 million in potential development and regulatory milestone payments,AndUp to $555 million in potential sales milestone payments。

According to an earlier announcement by CSPC, SYS6002 is a recombinant humanized anti-Nectin-4 ADC. The product utilizes CSPC's proprietary enzyme-catalyzed site-specific antibody-drug conjugation technology.An effective mitosis inhibitorMonomethyl Auristatin E (MMAE) specifically targets cancer cells expressing Nectin-4, and the stability of its linker also helps deliver high concentrations of MMAE to tumors while reducing side effects by minimizing adverse systemic exposure. The drug has already been approved for clinical trials in China and is intended to be developed for the treatment of solid tumors.

Licensor: Keymed Biosciences, Lepu Biopharma

Introducing Party: AstraZeneca

Authorized Products:ADC Targeting Claudin18.2

Indications:Solid Tumor

In February 2023, Keymed Biosciences and Lepu Biopharma jointly announced a global exclusive licensing agreement with AstraZeneca for CMG901.AgreementAstraZeneca will be responsible for the global research and development, manufacturing, and commercialization of CMG901. KYM Biosciences, a joint venture established by Connaught Medical and Lepu Biopharma, will benefit.$63 million upfront paymentAndUp to US$1.125 billion in potential additional R&D and sales-related milestone payments.CMG901 is aA novel ADC product targeting Claudin18.2,A phase 1 clinical study is being conducted for Claudin18.2-positive solid tumors.

Authorizing Party: Xinnuowei

Introducing Party: AmMax Bio

Authorized Product: ADC Project
Indications: Solid Tumors

2023In January, Xennovate announced an exclusive transfer agreement with AmMax Bio.Agreement, andInnovative ADC Products for Solid Tumor TreatmentGlobal R&D and commercialization rights outside of Greater China are granted to the latter. According to the agreement, Xinnov will receiveUp to $871 million in payments, including upfront payment, development, registration, and sales milestones, etc. The ADC product under this licenseAdopting a new generation of toxin-link and antibodyPreclinical studies have shown that it exhibits better anti-tumor activity in a variety of preclinical animal models, has a wider therapeutic window, and is expected to significantly improve clinical efficacy and safety characteristics.