Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has released its financial results for the year ended December 31, 2022, alongside updates on key clinical and commercial developments. Revenues for the year ending December 31, 2022, were USD 426.4 million, compared to USD 356.1 million in 2021, primarily driven by the commercialization of three in-house developed oncology products.
Product Sales Performance
The period saw oncology/immunology consolidated revenues increase by 37% (41% CER) to USD 163.8 million. Elunate (fruquintinib) sales rose 32% to USD 93.5 million over the 12 months, reflecting the drug’s expanding market share, particularly in tier 2 and 3 cities. Sulanda (surufatinib) sales surged 178% to USD 32.3 million (2021: USD 11.6 million), reflecting its first-time NRDL inclusion from January 2022. Orpathys (savolitinib) sales were up 159% to USD 41.2 million (2021: USD 15.9 million) following its launch in H2 2021 through AstraZeneca’s extensive oncology commercial organization. The rapid initial self-pay uptake is due to being the first-in-class selective MET inhibitor in China, and the company expects continued uptake to be supported by NRDL inclusion starting March 1, 2023. Tazverik (tazemetostat) was successfully launched via the Hainan Bo’ao Lecheng medical pilot zone in June 2022.
Regulatory Updates
During the period, HutchMed received Breakthrough Therapy Designation status in China for sovleplenib (HMPL-523) in January 2022 for the treatment of ITP, and approval for Tazverik in the Hainan Boao Lecheng International Medical Tourism Pilot Zone in May 2022 for the treatment of certain patients with epithelioid sarcoma or follicular lymphoma. Macau approvals for Elunate and Sulanda, the first drugs approved in the territory based on China NMPA approval, came following regulatory updates in Macau.
Abroad, a rolling NDA submission to the US FDA was initiated for fruquintinib in December 2022, for the treatment of refractory colorectal cancer (mCRC). The US FDA granted Fast-Track Designation status for the development of fruquintinib in patients with metastatic CRC in June 2020, enabling the company to submit sections of the NDA on a rolling basis. Fruquintinib submissions to the EMA and the Japanese PMDA are expected to follow the completion of the US NDA submission, all anticipated to be completed in 2023. Savolitinib was granted FTD status by the FDA for the combination treatment with Tagrisso (osimertinib) in NSCLC patients harboring MET overexpression and/or amplification following progression on Tagrisso alone. Surufatinib saw its US NDA and EMA MAA withdrawn. In Japan, the bridging study is continuing, and a pre-NDA PMDA consultation is targeted for the first half of 2023.
Collaboration Updates
In January 2023, Takeda signed with HutchMed to take development, manufacturing, and commercialization rights to Elunate in all indications and territories outside of mainland China, Hong Kong, and Macau. The deal is worth up to USD 1.13 billion, including a USD 400 million upfront payment on deal closure and up to USD 730 million in additional potential payments relating to regulatory, development, and commercial sales milestones, as well as royalties on net sales. Two Phase I trials were initiated in Australia and the US on two HutchMed drug candidates being developed by Inmagene: IMG-007, an investigative OX40 antagonistic monoclonal antibody designed to selectively shut down OX40+ T cell function; and IMG-004, a reversible, non-covalent, highly selective oral BTK inhibitor designed to target immunological diseases.
Strategic Implications
The strong performance of HutchMed’s oncology products and the progress in regulatory and collaborative efforts highlight the company’s commitment to advancing innovative treatments in the field of oncology and immunology. The expansion of its product portfolio and the strategic partnerships are expected to drive further growth and enhance the company’s position in the global market.-Fineline Info & Tech
