Haisco Pharmaceutical signs exclusive licensing agreement with U.S.-based AirNexis, with total deal value reaching $1.063 billion

Haisco Pharmaceutical announced that it has signed an exclusive license agreement with U.S.-based AirNexis Therapeutics, Inc. (formerly known as Dragonwell Biosciences, Inc., referred to as "AirNexis"), granting AirNexis the exclusive rights to develop, manufacture, and commercialize HSK39004 (AN01) globally, excluding China.

AirNexis will pay Haisco an upfront payment of $108 million (including $40 million in cash and equity worth approximately $68 million for 19.9% stake in AirNexis) as well as up to $955 million in additional milestone payments and royalties (total deal value of $1.063 billion). If AirNexis enters into a sublicensing deal for HSK39004, Haisco is also entitled to a share of the sublicensing revenue.

Haisco Pharmaceutical stated that, unlike the previous straightforward "License-out" model, this collaboration involved the establishment of a new entity (NewCo), enabling deep alignment and mutual growth with AirNexis and its investors. This move marks a further upgrade in Haisco's internationalization strategy.

On the day AirNexis announced its collaboration with Haisco, it also revealed the completion of a $200 million Series A financing round, with key investors including FLS, OrbiMed, Life Sciences at Goldman Sachs Alternatives, SR One, Longitude, and others.

FLS, the lead investor, invests globally in private and public companies engaged in the discovery, development, and commercialization of innovative biopharmaceuticals. Since 2016, FLS has raised over $5.3 billion, including venture funds focused on company creation and private firms, as well as long-only public funds targeting small- and mid-cap listed companies. Since 2010, companies within FLS's portfolio have secured FDA approval for more than 65 therapeutic drugs and have completed over 60 initial public offerings or strategic acquisitions.

It is noteworthy that Wang Junmin, the actual controller and Chairman of Haisco, also participated in this $200 million funding round for AirNexis, investing $5 million for 5 million shares, representing approximately 1.4% of its total share capital.

The proceeds from this financing round will be used to advance the global clinical development of AN01. AN01, also known as HSK39004, is a core product developed by Haisco in the respiratory field. As a dual PDE3/4 inhibitor, HSK39004 simultaneously inhibits PDE3 and PDE4, achieving bronchodilation and anti-inflammatory effects. Specifically, PDE3 (Phosphodiesterase 3) regulates airway smooth muscle, thereby dilating the airways, while PDE4 (Phosphodiesterase 4) is involved in the activation and migration of inflammatory cells in bronchial epithelial cells and activates the cystic fibrosis transmembrane conductance regulator to reduce mucus viscosity and improve mucociliary clearance. Dual inhibition of PDE3 and PDE4 demonstrates enhanced or synergistic effects on airway smooth muscle contraction and inflammatory responses, potentially providing an adjunctive maintenance treatment option for chronic obstructive pulmonary disease (COPD).

Furthermore, this drug has been innovatively developed in two dosage forms: an inhalation suspension and a dry powder inhaler. The dry powder inhaler can complete administration in a short time, with the entire inhalation process taking only 5 seconds from start to finish, significantly improving patient compliance compared to similar competing products. Both dosage forms have currently entered Phase II clinical trials in China. Clinical and preclinical data show that HSK39004 exhibits excellent airway bronchodilatory activity and anti-inflammatory efficacy, along with a favorable safety profile. As of December 31, 2025, the cumulative R&D investment for HSK39004 amounted to approximately RMB 70 million.

In addition to HSK39004, Haisco has several other pipelines in the respiratory disease field. According to its 2025 annual report, Haisco's HSK31858 tablet, indicated for non-cystic fibrosis bronchiectasis, has entered Phase III clinical trials. Subsequent Phase III clinical studies for this pipeline targeting bronchial asthma and COPD will be initiated according to strategy. HL231 inhalation solution, indicated for COPD, has completed enrollment of all subjects for its Phase III clinical study. HSK44459 tablet, indicated for idiopathic pulmonary fibrosis, is rapidly advancing into Phase II clinical studies.

COPD is a type of pulmonary disease encompassing chronic bronchitis and emphysema, characterized by chronic airway inflammation, and has become the third leading cause of death globally. According to data from the China Respiratory Disease Prevention and Control White Paper (2024), there are approximately 580 million COPD patients worldwide, including 180 million in China, with an average of 2.5 deaths per minute in China attributable to the disease, making it the fourth leading cause of death among Chinese residents. The disease is highly destructive, with patients often suffering from symptoms such as shortness of breath, chronic cough, and wheezing, making even daily activities like getting out of bed or taking a shower difficult to complete.

From a pathogenesis perspective, COPD involves multiple aspects including inflammation, oxidative stress, and protease-antiprotease imbalance, making it difficult for drugs with a single mechanism of action to comprehensively halt disease progression. In traditional treatment, bronchodilators and glucocorticoids are the main medications, often administered orally or via injection. Oral drugs require gastrointestinal absorption before entering the systemic circulation to reach the lungs, resulting not only in slow onset of action but also significant loss of active ingredients due to first-pass metabolism in the liver, making it difficult to achieve sufficient therapeutic concentrations at the pulmonary lesion sites. While injection can improve drug utilization to some extent, it presents challenges such as inconvenience of frequent injections, risk of infection, and potential systemic side effects with long-term use.

From a market perspective, the global COPD treatment market size in 2023 was RMB 107.052 billion, and it is projected to reach RMB 170.606 billion by 2029, with a compound annual growth rate of 8%. Despite the vast COPD market, there have been no novel drugs with entirely new mechanisms approved in this field for many years, with mainstream treatment regimens primarily relying on combination therapies using older drugs.

Faced with a market of hundreds of billions, leading multinational corporations (MNCs) such as AstraZeneca, Sanofi, GSK, Pfizer, Johnson & Johnson, Amgen, and Novartis are all vying to develop new COPD drugs. In China, besides Haisco, companies like Hengrui Pharma and Qyuns Therapeutics have also entered into licensing deals with MNCs related to COPD within the past year.

In July 2025, Hengrui Pharma entered into a collaboration with GSK, licensing its self-developed PDE3/4 inhibitor hrs-9821 and 11 projects covering oncology, respiratory, and autoimmune diseases to GSK, with a total deal value exceeding $12 billion (hrs-9821 is a potential best-in-class PDE3/4 inhibitor, primarily for treating COPD, achieving synergistic bronchodilation and anti-inflammatory effects through dual-target inhibition). In December 2025, Qyuns Therapeutics entered into a collaboration with Roche, licensing its self-developed QX031N to Roche, with a total deal value of $1.07 billion (QX031N is a long-acting bispecific antibody injection targeting TSLP and IL-33, expected to become an innovative therapy for COPD and asthma patients).

Overall, as the global burden of respiratory diseases increases, progress in the treatment of chronic respiratory diseases is attracting significant attention. The intense competition among MNCs and the rapid follow-up by Chinese pharmaceutical companies mark a transition in the industry's approach to treating chronic respiratory diseases from "broad-spectrum anti-inflammatory" to a new era of "precision targeting." The value of related pipelines lies not only in filling drug gaps in specific areas like COPD but also in validating the druggability of China's innovative pipelines, opening new pathways for treating diseases such as bronchiectasis, chronic obstructive pulmonary disease, asthma, and autoimmune disorders.