On February 29, CDHT's First BD Salon on "Biomedicine Global Expansion" in 2024 was successfully held online and offline at Chengdu Advanced Medical Science Center.

      Cao Hui, Senior BD of Abbott Laboratories (Abbot), Hao Ruiyi, BD of Keymed Biosciences, and Gu Yang, Partner Lawyer of Han Kun Law Offices shared the main concerns of License In/Out from the perspectives of buyers, sellers, and agreement consultants respectively. Nearly 30 BDs and R&D heads from Chengdu biomedical enterprises including Hyperway, Xiling Lab, Easton Biopharmaceuticals, and Hinova Pharmaceuticals attended the salon.

       Cao Hui, Senior BD of Abbott,

      reviewed the five main modes of pipeline asset purchases (commercialization equity authorization, acquisition, and License In) and direct investments (M&A and equity investment) of BDs in multinational companies (MNCs) in China amidst China's engineering talent boom and since the implementation of encouraging policies and ICH guidelines for China's innovative drugs.

      She pointed out that in addition to economic factors like pricing, MNCs prioritize evaluating the synergies between Biotech-related equity assets and their core business during external collaborations and licensing agreements. They closely examine market barriers and centralized procurement risks for marketed products.

      Currently, Abbott (China) mainly implements BD plans around pipelines in the fields of gynecology, digestion, psychiatry, pediatrics, cardiovascular system, and metabolism, and keeps a close eye on the innovation achievements of Chengdu biomedical enterprises.

       Hao Ruiyi, BD of Keymed Biosciences,

     shared the main process of the global exclusive licensing agreement for CMG901 (an ADC drug targeting Claudin 18.2) and highlighted that robust organizational capability is the crucial assurance for Biotech to effectively expand overseas through License Out partnerships.

     Building upon preliminary research, Keymed Biosciences established a dedicated working group comprising the founder team and core technical staff focusing on the overseas BD of CMG901. They engaged with MNC working groups through dynamic problem lists, rough order of magnitude (ROM), and specialized meetings. Despite time zone differences and holidays, project members, including colleagues from MNC, experienced a period of close collaboration "day and night," fostering deep and lasting friendships. Hao emphasized that a successful License Out case necessitates the BD personnel to have a clear understanding of the entire life cycle, encompassing pipeline R&D and commercialization. Besides, it is crucial to view the impact of the deal holistically with the assistance of professional lawyers: while signing an agreement is pivotal, it is more critical to retrospect and drive forward effective cooperation post-signing.

       Gu Yang, Partner Lawyer of Han Kun Law Offices,

      reviewed the status of biomedical license transactions in China from 2021 to January 2024 and shared insights on the framework, transaction process, and core clause design for license projects. He highlighted that the record-high number of license out transactions and total down payment amount in 2023 implies that Biotech can secure additional cash flow through down payments for subsequent stages such as drug development and commercialization.

      Lawyer Gu believes that in a License Agreement, combining a "good price" with "good terms" leads to commercial benefits. Based on the six key categories of regulatory registration, license authorization, intellectual property rights, financial terms, diligence obligations, and competition terms, he emphasized the design of core terms of the License Agreement at different stages from pipeline R&D to post-marketing supervision. He advised that emphasis should be placed on R&D responsibilities and research data sharing during the R&D stage; selection of MAH, leader, and assister during the registration stage; manufacturing supplier, technology transfer, and quality agreements during the production stage; and commercial responsibilities, diligence obligations, and product vigilance during the commercialization and post-marketing supervision stage.

      Lawyer Gu introduced in detail the down payment, (R&D/sales) milestone payment, sales sharing, sub-license fee, and other contents of the financial gain terms, and explained the tax arrangements and post-termination arrangements of the agreement.