Hengrui Medicine Secures $12 Billion Deal with GSK for PDE3/4 Inhibitor HRS-9821, Igniting Global COPD Investment Surge

On July 28, 2025, Hengrui Pharma reached a significant deal with GSK, potentially worth up to $12 billion. This agreement covers the global exclusive rights (excluding Greater China) to HRS-9821, a PDE3/4 inhibitor currently in clinical development, and grants GSK exclusive options for the global development and commercialization of up to 11 of Hengrui's early-stage pipeline products.

This is not only the largest outbound licensing deal in Hengrui Pharma's history but also sets a new record for the transaction ceiling of Chinese innovative pharmaceutical companies going global, marking a milestone event.

More notably, this deal was not an "accidental burst," but a concentrated reflection of global capital reassessing the value of the respiratory treatment track. On July 9, Merck just acquired UK-based Verona Pharma for $10 billion, whose core asset is a dual inhibitor also targeting PDE3/4.

Two giants have successively placed their bets, and COPD, a field once considered "too traditional," is being re-evaluated; meanwhile, Chinese pharmaceutical companies are beginning to occupy an increasingly central position in the global capital chessboard.

Chronic Obstructive Pulmonary Disease (COPD) is a highly underserved disease area. As of 2019, there were approximately 390 million patients globally. The global COPD treatment market size was about $20 billion in 2024 and is expected to reach nearly $33 billion by 2034, with a compound annual growth rate (CAGR) of approximately 5.14%. Currently available medications mostly rely on traditional bronchodilators and glucocorticoids, lacking innovative treatments with a dual mechanism of "bronchodilation + anti-inflammation."

The rise of PDE3/4 dual inhibitors fills this gap perfectly. Their mechanism not only relaxes bronchial smooth muscle but also has the potential to suppress the activity of inflammatory cells, representing a shift in COPD treatment from single-target breakthroughs to mechanism integration. In June 2024, Verona Pharma's Ensifentrine received FDA approval, marking the first global clinical validation of this mechanism and becoming a signal for global pharmaceutical companies to invest in this area.

Hengrui Pharma's HRS-9821, authorized to GSK this time, is also a PDE3/4 inhibitor administered via DPI (dry powder inhalation) and targeted for use in the maintenance treatment phase of COPD. A key feature of this drug is that "there is no need to consider the patient's prior treatment history," theoretically making it easier to secure a front-line position in international guidelines.

Compared with Verona's Ensifentrine, HRS-9821 is currently at an earlier stage (still in clinical development) but has differentiation potential in the following aspects:

· Dosage Form Strategy：HRS-9821Adopted since the project was initiatedDPIRoute, AlignmentCOPDThe need for home use in maintenance therapy. In contrast,EnsifentrineAlthough approved as a nebulized formulation, itsDPIAndpMDIThe version is still in the early stages of development. Hengrui PharmaDPIFocus on the path may help to form a first-mover advantage in terms of process and commercialization rhythm.

· Development Rhythm: Hengrui Pharma completed in ChinaCMCIn line with the preliminary clinical design, while promoting overseasIThe initiation phase saved time costs in cross-border collaboration and also enhanced the control over the project pace.

· Target Population： GSKThe CoreCOPDAlthough the product has been approved in China, its sales still heavily rely on the European and American markets, with a relatively low penetration rate in the Asia-Pacific region.HRS-9821Accumulating preliminary data in the Asian population, with the hope of making up forGSKThe product line's coverage gaps in emerging markets provide it with greater global market extensibility.

However, it should be noted that the regulatory and market barriers in this field remain high. Europe and the U.S. have strict standards for the stability of inhalation devices, consistency of dosage forms, and pulmonary delivery efficiency. Hengrui Pharma will still need to invest resources in CMC consistency, inhaler design, and avoiding patent barriers to achieve effective implementation.

Unlike an outright buyout, Hengrui Pharma’s deal this time adopts an “option structure”: GSK pays a $500 million upfront fee for global development and commercial rights (excluding Greater China) to HRS-9821 and holds phased exclusive options on up to 11 early-stage pipelines. The key to this model is:

· Retain Control: Hengrui Pharma can continue to lead the clinical advancement and maintain control over the data节奏.

· Risk Sharing：GSKSelect whether to take over the project at each node to reduce early pressure on both sides;

· Value Increase: WithICompletion on schedule, clear data, and higher value of subsequent options.

This structure avoids the "early data sold at a low price" problem commonly faced by Chinese pharmaceutical companies, providing a referenceable design approach for similar enterprises.

The high number of respiratory disease patients, clear pathological mechanisms, and well-defined efficacy evaluation criteria make the respiratory field an ideal starting point for Chinese pharmaceutical companies to accumulate international clinical and registration experience.

But the reality is that products from multinational giants like GSK and AZ have long dominated, with high technical barriers and market entry obstacles. The delivery technology for inhalation formulations and patient compliance management are complex, with long R&D cycles and high costs. Coupled with differences in clinical design standards and health insurance policies across regions globally, achieving success overnight is almost impossible.

Hengrui's licensing case tells us: the respiratory field is not an "easy track," but a "must-contend-for battleground" that demands solid strength. For Chinese pharmaceutical companies to win in the future, they must rely on robust overseas clinical data, technological innovation, and targeted strategies, proceeding steadily to truly break through international markets and carve out their own path.

Hengrui Pharma's licensing deal not only marks a breakthrough in financial terms but also represents a significant rise in industry influence. It strategically taps into the respiratory track undergoing capital reevaluation, earning recognition from multinational giants through a mature BD model. This milestone reflects remarkable progress in the globalization journey of China's innovative pharmaceutical enterprises.

The respiratory system might just be the first "language" through which Chinese pharmaceutical companies are understood in the international market.

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