▎Edited by the WuXi AppTec content team

As August draws to a close, the field of licensing partnerships for innovative drugs in China has remained highly active this month. According to the Immediate Pharma Database, as of August 26, Chinese companies have reached at least 12 licensing partnership cases for innovative drugs in August, with disclosed total amounts potentially reaching up to 58 billion US dollars*.Among themPuzhong Discovery, Tongrun Biotech, Genor Biopharm, and ImmuneOnco have reached "license-out" international licensing collaborations for innovative drugs. Salubris, Hansoh Pharma, Huadong Medicine, and MSD have introduced multiple innovative products.（*This article provides an incomplete statistical overview, showcasing only a portion of innovative drug licensing and collaboration events.)

Through combing,The following characteristics and trends were identified:

• In terms of product types, the products covered by the licensing collaboration includeSmall molecules, monoclonal antibodies/bispecific antibodies, antibody-drug conjugates (ADC), CAR-T cell therapy drugs, base editing drugsand many other types;

• From the perspective of product development stages, about half of the products are in the early stages of development (prior to Phase 2), including at least three licensed products still in preclinical development.

• In terms of the amount of authorized cooperation, the total amount of at least 8 cooperations has exceeded 1 billion yuan,Among them, there are at least three cooperation agreements with amounts exceeding 1 billion US dollars;

• In terms of disease areas, at least five licensed collaboration products target cancer, while other products cover fields such as autoimmune diseases, cardiovascular, ophthalmology, and more.

Image Source: 123RF

Authorizing Party: Yaotang Biotech

Importer: Salubris

Product:YOLT-101

Mechanism of Action:PCSK9 Target Base Editing Drug

On the evening of August 26, Salubris announced that it plans to sign an agreement with YolTech Therapeutics.Agreement, obtaining the latter's research pipelinePCSK9 Target Base Editing DrugThe exclusive license rights for YOLT-101 in mainland China, including but not limited to research and development, registration, production, and commercial sales. YOLT-101 is currently in the preclinical research stage, with proposed indications under development includingFamilial Hypercholesterolemiaetc.

Salubris will make payments using self-raised funds based on the progress of the transaction and R&D, with the total amount of the upfront payment and R&D milestone payments not exceeding 205 million yuan. If the product is approved for marketing, Salubris will also pay sales milestone fees.Cumulative sales milestones not exceeding 830 million yuan at most。

Authorizing Party: Puzhong Discovery Pharmaceutical Technology(Shanghai) Co., Ltd.

Introducing Party:Adcendo Company

Product:AMT-754

Mechanism of Action: Antibody-Drug Conjugates (ADC) Targeting TF

On August 20, Puzhong Discovery Pharmaceutical Technology(Shanghai) Co., Ltd.（Multitude Therapeutics）And Adcendo jointly announced that the two partiesA novel, highly differentiated ADC product targeting tissue factor (Anti-TF)ADCE-T02 (Puzhong Discovery's R&D code: AMT-754)AchieveLicense AgreementAdcendo will obtain the global exclusive rights for the development and commercialization of the product outside of Greater China, while Puzhong Discovery will retain the rights for development and commercialization within Greater China.ADCE-T02 has been submitted for clinical trial in Australia and is expected to file for U.S. IND in the near future.

Puzhong Discovery and Adcendo are both clinical-stage biopharmaceutical companies focused on the development of ADC products.According to the financial terms of the agreement, Puzhong Discovery Pharmaceutical Technology(Shanghai) Co., Ltd. will receiveTens of Millions of Dollars in Upfront Payments, and will charge upon reaching subsequent development, regulatory, and commercial milestones.Totaling over 1 billion US dollarsTotal milestone payments.

Authorizing Party: Kelun-Biotech

Importer: Merck

Product:SKB571 Project

Mechanism of Action: Bispecific Antibody-Drug Conjugate (ADC)

News on August 20, based on the continuation of the previously reached cooperation,Kelun BotaiReceivedMerckWritten Notice,MSD willInnovative Bispecific ADC ProjectSKB571 Project Exercises Exclusive Option and Pays Kelun Biotech $37.5 Million, and further milestone payments will be made to Kelun Botai upon reaching specific development and sales milestones. Kelun Botai will retain the rights to cross-regional development, use, manufacturing, and commercialization of SKB571 in mainland China, Hong Kong, and Macao.

SKB571 is an innovative bispecific antibody-drug conjugate (ADC), primarily targeting various solid tumors such as lung cancer and gastrointestinal tumors.The product will be submitted for an IND application in the near future.It is reported that,Kelon Biotech also plans to submit IND applications for other preclinical ADC assets that have reached licensing cooperation agreements with Merck in the near future, while continuing to explore new collaboration opportunities with Merck.

Authorizing Party:IMBiologics

Importer: Huadong Medicine

Product:IMB-101 and IMB-102

Mechanism of Action:Bispecific and Monoclonal Antibodies Targeting OX40L

August 14 News: Huadong Medicine's wholly-owned subsidiary, Sinopharm Zhongmei Huadong, and IMBiologics (a South Korean biotechnology company focused on developing innovative products for autoimmune diseases and cancer), announced an exclusive strategic cooperation agreement for the development, registration, manufacturing, and commercialization of IMB-101 and IMB-102 in 37 Asian countries including China (excluding Japan, South Korea, and North Korea).Huadong Medicine will be responsible for the development, registration, production, and commercialization of the licensed products in the licensed region.IMBiologics will receive an upfront payment of $6 million, a $2 million technology transfer milestone payment, and up to $307.5 million in development, registration, and sales milestone payments.。

IMB-101 isBispecific Antibody Targeting OX40L and TNFα, which is currently in Phase 1 clinical trials in the United States, intended for the treatment of rheumatoid arthritis. IMB-102 is aMonoclonal Antibody Targeting OX40L, which is currently in the preclinical research stage, with potential indications including moderate to severe atopic dermatitis and other autoimmune diseases.

Authorizing Party: Alcon

Introducing Party:Ocumension

Product:Dry Eye Treatment and Surgical Ophthalmic Solution Product Portfolio

Authorizing Party:Tongrun Biopharmaceuticals

Introducer: Merck

Product:CN201

Mechanism of Action:CD3/CD19Bispecific Antibody

Authorizing Party: Lupeng Pharmaceuticals

Introducing Party:Hansoh PharmaPharmaceuticals

Product:LP-168

Mechanism of Action:Next-Generation BTK Inhibitor

As of now, Lu Peng Pharmaceutical is conducting multiple clinical studies on LP-168, with its most advanced stage of development in China being a pivotal Phase 2 registration clinical trial for tumors. According to the press release, this collaboration will enableHansoh PharmaFurther Expand the Pipeline Portfolio for Treating Autoimmune Diseases。

Authorizing Party:Bokang Vision Cloud

Introducing Party:Santen Pharmaceutical

Product:CBT-001

Mechanism of Action: Multikinase Inhibitor

CBT-001 is a product developed by Bokang Vision Cloud.Emulsified Nintedanib Eye Drops, mainly used for the treatment of pterygium.Nintedanib is a multi-kinase inhibitor that primarily targets VEGF (vascular endothelial growth factor) receptors, PDGF (platelet-derived growth factor) receptors, and FGF (fibroblast growth factor) receptors, thereby inhibiting angiogenesis and fibrosis.CBT-001 can provide doctors and patients with a new treatment option for pterygium through eye drops, inhibiting disease progression. The product has alreadyPhase 2 clinical trials have been completed in the United States, and large-scale global multi-center Phase 3 clinical trials are currently being conducted in the United States, China, Australia, New Zealand, and India.

Authorizing Party: Genor Biopharma

Introducing Party:TRC 2004

Product:GB261

Mechanism of Action:CD20/CD3 Bispecific Antibody

On August 5, JHBP announced that it had entered into a licensing agreement and equity arrangement with TRC 2004 (a company co-founded by Two River and Third Rock Ventures).Agreement. According to the agreement,Genor BiopharmaHas agreed to grantTRC 2004Global exclusive license to develop, use, manufacture, commercialize, and otherwise exploit GB261(Excluding mainland China, Hong Kong, Macao and Taiwan areas)。Genor Biopharma will obtainA substantial number of equity shares, tens of millions of dollars in upfront payments, and milestone payments of up to 443 million US dollars.And tiered royalties ranging from single-digit to double-digit percentages of net sales.

GB261 is aNovel Differentiated CD20/CD3 Bispecific T Cell Engager (TCE)`, with ultra-low CD3`Combining affinity and complete Fc function (ADCC and CDC). JHL Biotech previously in China and AustraliaCompleted forB-cell Non-Hodgkin LymphomaPhase 1/2 Multicenter Study. This timeAndTRC 2004The cooperation will mainly focus on exploring GB261 in autoimmune diseasesPotential in the aspect.

Authorizing Party: Yimiao Zhongguo

Introducing Party:Huadong Medicine

Product:IM19 Injection

Mechanism of Action:CD19-targeted CAR-T product

On August 4, Huadong Medicine and Yimiao Shen Zhou announced that the two partiesAutologous CAR-T candidate product targeting CD19IM19 Injection Reaches Agreement in Mainland ChinaCommercial Cooperation。According to the terms of the agreement, Yimiao Zhongshen will receive an upfront payment of 125 million RMB and is eligible to receive registration and sales milestone payments of up to 950 million RMB.Yimiao Zhongshen will continue to be responsible for the development, registration, and production of IM19 injection in mainland China.

IM19 Injection is the first CAR-T cell therapy product independently developed by Yimiao Zhongshen, targeting relapsed or refractory diffuse large B-cell lymphoma, acute B lymphoblastic leukemia, and mantle cell lymphoma.Three indications have enteredClinical Research Phase. Yimiao ZhongyuanExpected to submit the marketing authorization application for this product in the fourth quarter of 2024.。

Authorizing Party: Runjia Pharmaceuticals

Introducing Party:Mabwell

Product:RP901 Project and Companion Diagnostics

Mechanism of Action: Small Molecule Drugs

August 2,Mabwell Announces that Its Wholly-Owned Subsidiary Taikang Bio Has Signed with Runjie PharmaLicense AgreementRunjia Pharmaceuticals licenses Taikang Bio to research, develop, register, commercialize, and sell in the Greater China region.RP901 Project and Companion Diagnostics (Developed Solely for the Purpose of Using Licensed Products)The rights and interests. According to the agreement, Runjia Pharmaceuticals will receive an upfront payment of 50 million RMB, with potential development and registration milestone payments, as well as commercial milestone payments, reaching up to 1.07 billion RMB, along with royalty fees of up to 10% of net sales.

RP901 is a small molecule drug in the field of osteoarthritis treatment.After oral administration into the human body, it can accumulate in the joint cavity. By enhancing the anabolic metabolism of articular cartilage and reducing the catabolic metabolism of articular cartilage, it improves cartilage damage in patients with osteoarthritis, thereby exerting a therapeutic effect on osteoarthritis. This productLaunched in March this yearPhase 2 Clinical Study for the Treatment of Knee Osteoarthritis。

Authorizing Party: ImmuOnco

Introducing Party:Instil Bio

Product:IMM2510、IMM27M

Mechanism of Action: PD-L1xVEGF Bispecific Antibody; Next-Generation CTLA-4 Antibody

August 1,Immunotech announces partnership with Instil BioAgreement. According to the agreement, InstilBioThe company will obtain ImmuOnco's proprietaryPD-L1xVEGF Bispecific Antibody IMM2510AndNext-Generation CTLA-4 Antibody IMM27MDevelopment and commercialization rights outside of Greater China.Immunotech will retain the development and commercialization rights in the Greater China region, whileIt will receive an upfront payment of up to US$50 million and potential near-term payments, and is eligible to receive milestone payments totaling over US$2 billion upon the achievement of certain development, regulatory, and commercial milestones.

IMM2510 is a novel, potential "best-in-class" PD-L1xVEGF bispecific antibody that has completed a dose-escalation clinical trial for advanced solid tumors; IMM27M is a next-generation CTLA-4 antibody with enhanced ADCC activity, which has completed a dose-escalation clinical trial and entered a combination study with IMM2510 in China in July 2024.