On July 28, GlaxoSmithKline (GSK) acquired the global exclusive rights (excluding Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan) of Hengrui Medicine's PDE3/4 inhibitor HRS-9821 project and the exclusive option for global exclusive licensing of up to 11 projects for a total transaction amount of up to US$12.5 billion.

Just two weeks ago, Merck acquired Verona Pharma for US$10 billion. Its core asset is Ohtuvayre (Ensifentrine), the world's first PDE3/4 inhibitor.

These two billion-dollar transactions, centered on PDE3/4 inhibitors, suddenly ignited the global battle for respiratory therapy.

According to Hengrui Medicine's announcement, GSK will pay Hengrui a down payment of US$500 million. If all projects are exercised and all milestones are achieved, Hengrui will be eligible to receive a potential total of approximately US$12 billion in future payments based on successful development, registration and sales milestones. Hengrui will be entitled to receive corresponding tiered sales commissions from GSK (excluding mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan).

HRS-9821 is a potential best-in-class PDE3/4 inhibitor. The drug is currently in Phase I clinical development and is intended for use as an adjunct maintenance therapy for chronic obstructive pulmonary disease (COPD).

The drug has shown potent PDE3 and PDE4 inhibition in early clinical and preclinical studies, resulting in enhanced bronchodilator and anti-inflammatory effects and providing an opportunity for the development of a convenient dry powder inhaler (DPI) formulation.

According to titer data, in addition to Hengrui Medicine, other Chinese pharmaceutical companies that are currently developing PDE3/4 inhibitors include China Biologic Products and Hisun Pharmaceutical.

Among them, the TQC3721 suspension of Sino Biopharmaceutical's Zhengda Tianqing has been approved by the CDE to conduct a Phase III registration clinical study for the maintenance treatment of COPD. Compared with the PDE3/4 products that have been launched on the market, the Phase III clinical study of TQC3721 will additionally include patients with background treatment of double bronchodilators, covering a wider range of COPD patients. In addition, in addition to the suspension for inhalation, the TQC3721 inhalation powder is in the Phase I clinical development stage, and the dry powder dosage form is expected to further improve patient compliance.

Both HSK39004 inhalation suspension and inhalation powder have entered the Phase II clinical trial stage.

The transaction between GSK and Hengrui Medicine also involves 11 other projects, covering innovative drugs in multiple therapeutic areas such as tumors, respiratory, autoimmune and inflammation. However, these projects are still in the preclinical stage, and Hengrui has not disclosed specific project details.

Hengrui will lead the research and development of these projects until the completion of Phase I clinical trials including overseas subject data. GSK will have the exclusive option to further develop and commercialize each project globally (excluding mainland China, Hong Kong SAR, Macao SAR and Taiwan) and the right to replace certain projects until the completion of Phase I clinical trials.

Conclusion

In recent years, Hengrui Medicine has accelerated its global expansion. This transaction is its first blockbuster BD after its listing on the Hong Kong Stock Exchange in May this year. The down payment of US$500 million and the milestone payment of US$12 billion not only provide Hengrui Medicine with a considerable short-term income, but also help expand the overseas market for HRS-9821 and multiple innovative products, further enhancing the company's innovative brand and overseas performance.

Source: https://news.yaozh.com/archive/45836.html