Hutchison China MediTech Limited Reports 2020 Full Year Results and Provides Business Updates and Evolves Corporate Identity

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 04, 2021 (GLOBE NEWSWIRE) — Hutchison China MediTech Limited (“HUTCHMED”) (Nasdaq/AIM: HCM), an innovation-driven, commercial-stage biopharmaceutical company, today reports its audited financial results for the year ended December 31, 2020 and provides updates on key clinical and commercial developments.   The Company also intends to seek shareholders’ approval to change its name to HUTCHMED (China) Limited at its forthcoming Annual General Meeting. For more information on the new corporate name, see 2020 Full Year Results & Business Updates—VI. Evolution of Our Corporate Identity.
2020 FULL YEAR RESULTS & BUSINESS UPDATES“At the heart of HUTCHMED lies a prolific in-house novel drug discovery and development engine that has produced ten clinical-stage drug candidates and a further seven late-stage preclinical assets in oncology and immunology over the past fifteen years.” said Mr. Simon To, Chairman of HUTCHMED. “Our aim is to bring these internally discovered and developed innovations to patients the world-over.”“To support this strategic objective, we have built an oncology and immunology operation with around 1,200 personnel based mainly in our two core markets, China and the U.S. In China, supported by a robust manufacturing infrastructure, our commercial team is now delivering impressive sales results on our first two oncology drugs, ELUNATE^® in metastatic colorectal cancer and the recently launched SULANDA^® in neuroendocrine tumors. A New Drug Application was also submitted mid-last year for savolitinib in lung cancer and, subject to approval, it will be our third approved oncology drug and the first-in-class selective MET inhibitor on the market in China.”“Outside China, our fast expanding international organization, led mainly from the U.S., is developing five un-partnered oncology drug candidates. In 2020, it achieved three U.S. Food and Drug Administration fast track designations and initiated the rolling submission of surufatinib, our first U.S. New Drug Application filing.”  “Over the next three years, we will continue to grow our R&D and commercial organizations globally to support the anticipated launch of our oncology drugs in China, the U.S. and Europe.”I. COMMERCIAL OPERATIONSFull year 2021 Oncology/Immunology consolidated revenues guidance $110-130 million (2020 actual: $30.2m) with in-house oncology commercial organization in China now expanded to over 420 personnel (end 2019: about 90) covering over 2,300 oncology hospitals and over 20,000 oncology physicians;ELUNATE^®(fruquintinib) in-market sales increased 91% to $33.7 million¹ (2019: $17.6m), as provided by Lilly², during 2020 as a result of inclusion in the 2020 China NRDL³;Accelerating sales growth on ELUNATE^® since Q4 2020 when HUTCHMED assumed responsibility for all on-the-ground medical detailing, promotion and local and regional marketing activities in China;  
* = Unaudited; ** = Represents total sales to third parties as provided by Lilly; *** = Represents manufacturing fees, commercial service fees and royalties paid by Lilly to HUTCHMED, and sales to other third parties invoiced by HUTCHMED.Launched SULANDA^®(surufatinib) as a treatment for patients with advanced non-pancreatic NET⁴ in China in mid-January 2021 within three weeks of approval. Unaudited sales of SULANDA^® in January-February 2021, in its first two months on the market, were $4.9 million; andEstablished our U.S. commercial organization with the recruitment of senior leadership team based in New Jersey to prepare launch readiness for the potential surufatinib U.S. approval in late 2021 or early 2022.II. REGULATORY ACHIEVEMENTSChinaReceived China approval for SULANDA^® from the China NMPA⁵ as a treatment for patients with advanced non-pancreatic NET in December 2020;Submitted a China NDA⁶for savolitinib as a treatment for patients with MET⁷ Exon 14 skipping alteration NSCLC⁸. The NDA was accepted in May 2020. Priority Review status was granted in July 2020 and review is underway;Submitted a second China NDA for SULANDA^® as a treatment for patients with advanced pancreatic NET. The NDA was accepted in September 2020 and review is underway; andIND⁹cleared for HMPL-295, a novel ERK¹⁰ inhibitor in the MAPK pathway¹¹, in late 2020.United States & EuropeInitiated surufatinib U.S. FDA¹²rolling submission of a NDA for the treatment of both pancreatic and non-pancreatic NET in December 2020;Secured U.S. FDA Fast Track Designations for surufatinib for the treatment of both pancreatic and non-pancreatic NET in April 2020;Received scientific advice from the EMA¹³CHMP¹⁴ for surufatinib for the treatment of both pancreatic and non-pancreatic NET with no MAA¹⁵ filing issues identified;Secured U.S. FDA Fast Track Designation for fruquintinib for the treatment of advanced CRC¹⁶ in June 2020; andCleared two U.S. FDA INDs for HMPL-306 in late 2020, in hematological malignancies and solid tumors.
III. CLINICAL DEVELOPMENT ACTIVITIESSurufatinib (SULANDA^®in China), a small molecule inhibitor of VEGFR¹⁷, FGFR¹⁸and CSF-1R¹⁹designed to inhibit tumor angiogenesis and promote the body’s immune response against tumor cells via tumor associated macrophage regulation; approved and launched in China