Hengrui Medicine Secures $500 Million Upfront in Landmark $12.5 Billion Out-Licensing Deal with GSK for COPD Drug HRS-9821 and 11 Pipeline Assets

July 28,Hengrui Pharma Announces Signing of Collaboration, Option and License Agreement with UK-Based GSK: Global Exclusive Rights (excluding mainland China, Hong Kong, Macao, and Taiwan) for HRS-9821 Project and Global Exclusive License Options (excluding mainland China, Hong Kong, Macao, and Taiwan) for up to 11 Projects Granted to GSK for a Total Deal Value of up to $12.5 Billion.

This transaction not only set a new record for Hengrui Pharma in overseas licensing deals but also ranked as the second-highest total amount for China's innovative drug outbound licensing deals.

01 Record-Breaking Deal

The BD transaction targets of Hengrui Pharma this time include HRS-9821 and 11 ongoing projects.

HRS-9821It is a potential best-in-class PDE3/4 inhibitor currently in clinical development for the adjunctive maintenance treatment of chronic obstructive pulmonary disease (COPD), regardless of the patient's prior treatment regimen. Early clinical and preclinical studies have shown that the drug exhibits potent PDE3 and PDE4 inhibitory effects, significantly enhancing bronchodilation and anti-inflammatory effects, and offers the possibility of developing a convenient dry powder inhaler (DPI) formulation.

In addition11 itemsRuleInnovative drugs covering multiple therapeutic areas such as oncology, respiratory, autoimmune, and inflammation are currently in the non-clinical research stage.According to the agreement, Hengrui will lead the development of these projects and is required to complete Phase I clinical trials, including data from overseas participants, within the latest timeframe. GSK holds an exclusive option to further develop and commercialize each project globally (excluding designated regions) once Hengrui completes the Phase I clinical trial (at the latest by this stage). Additionally, GSK retains substitution rights for certain projects.

Accordingly,GSK to Pay Hengrui Pharma $500 Million as Upfront PaymentIf all options are exercised and all milestone targets are achieved, Hengrui will be eligible to receive milestone payments based on successful development, registration, and sales.Total potential amount approximately 12 billion US dollarsIn addition, Hengrui will have the right to collect corresponding tiered sales royalties from GSK (excluding specified regions).

02 Hengrui Pharma Intensifies Competition in COPD Market

The global number of patients with COPD exceeds 380 million (approximately 150 million in China). Traditional therapies (such as hormones and bronchodilators) cannot fully control acute exacerbations, making dual-target inhibitors a breakthrough treatment due to their "anti-inflammatory + vasodilation" dual mechanism.

Among them, inhaled preparations have become the mainstream development direction (such as DPI, suspensions) due to their direct action on the lungs and fewer systemic side effects.

The global PDE4 inhibitor market is expected to reach $3.45 billion by 2025, with a compound annual growth rate (CAGR) of 8% from 2025 to 2032, holding the highest share in the respiratory field (mainly driven by COPD). In particular, the COPD treatment market in China has yet to reach saturation.

Currently, the only drug approved by the FDA for COPD maintenance treatment is Ensifentrine (brand name: Ohtuvayre) from Verona Pharma, which received approval in June 2024. This marks the first new mechanism inhalation drug in nearly two decades.

• It achieves dual inhibition of PDE3/4, providing both bronchodilation and anti-inflammatory effects, and supports administration via a standard nebulizer (without complex operation).

• Sales reached $42 million in 2024, increased to $71.3 million in the first quarter of 2025, and exceeded $100 million in cumulative sales within 8 months of its market launch. Analysts predict that peak sales could approach $4 billion.

Merck Acquires Verona for $10 Billion in July 2025, accelerating the expansion of Ensifentrine's indications in areas such as non-cystic fibrosis bronchiectasis and asthma, and developing new formulations such as powder inhalers and metered-dose inhalers.

Other multinational pharmaceutical companies (such as Pfizer, Amgen) focus on PDE4 single-target inhibitors (such as Roflumilast), mainly used for severe COPD, while dual-target inhibitors have become an innovative focus due to their synergistic effects.

There are no marketed products in this field in the Chinese market.

Currently, Ensifentrine has not been approved in mainland China and is only available through the pilot programs in Macao and Boao, Hainan. Nuance Pharma plans to submit an NMPA marketing application in the second half of 2025.

The competitive梯队 in China is as follows:

• First Tier:TQC3721 by Zhongsheng Pharmaceutical (Chia Tai Tianqing)(Inhaled suspension), the fastest progress in China, has entered Phase III clinical trials for moderate to severe COPD, with global development progress second only to Ensifentrine.

• The Second Tier:Hengrui Pharma's HRS-9821(Inhaled powder/suspension), currently in clinical development, focuses on COPD adjunctive maintenance therapy. Early studies show potent PDE3/4 inhibition, and the exploration of dry powder inhaler (DPI) formulations aims to accommodate a broader patient population (more convenient than nebulizers, without the need for hand-mouth coordination).

• Chaser:Haisco's HSK39004(Inhalation Suspension/Powder Inhaler) in clinical trial phase.

This time, Hengrui Pharma has received a $500 million upfront payment and global commercialization support (excluding China) through its collaboration with GSK, which will accelerate the overseas validation of HRS-9821.