HUTCHMED (China) Limited American Depositary Shares - HCM STOCK NEWS

HUTCHMED announces the first commercial sale of ORPATHYS^® (savolitinib) in China, which occurred on July 12, 2021. This follows the June 22, 2021 approval for treating non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping alterations. A milestone payment of $25 million from AstraZeneca is triggered by this sale. ORPATHYS^® targets a critical mutation affecting 2-3% of NSCLC patients, with a notable prevalence in aggressive subtypes. The drug's efficacy is supported by robust clinical trial data, showing a 42.9% objective response rate.

HUTCHMED (HCM) announced the full exercise of the over-allotment option in its Global Offering, resulting in the issuance of 15,600,000 shares at HK$40.10 each. This increases total issued shares to 864,115,660, with CK Hutchison Holdings now holding 38.48% of voting rights. The gross proceeds are approximately HK$625 million, earmarked for existing projects. Listing on the Hong Kong Stock Exchange is set for July 15, 2021, with AIM admission at the London Stock Exchange expected on July 16, 2021.

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) has initiated a Phase I study for HMPL-295, an oral ERK inhibitor targeting the RAS-MAPK pathway. The trial started on July 2, 2021, assessing HMPL-295's safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced malignant tumors. This study aims to establish the maximum tolerated dose and recommended Phase II dose. HUTCHMED retains all rights to HMPL-295 worldwide, marking a significant step in addressing resistance in cancer therapies.

HUTCHMED (HCM) will announce its interim results for the six months ending June 30, 2021, on July 28, 2021, at 12:00 noon BST. Analysts and investors are invited to participate in a conference call at 1:00 pm BST, which will be live-streamed on the company's website. As a biopharmaceutical company focused on cancer and immunological disease therapies, HUTCHMED has advanced multiple drug candidates into clinical studies, with three oncology drugs already approved. More details will be provided in the financial results announcement.

The U.S. FDA has accepted HUTCHMED's New Drug Application (NDA) for its novel oncology drug, surufatinib, aimed at treating pancreatic and extra-pancreatic neuroendocrine tumors (NETs). The target action date is set for April 30, 2022. Surufatinib, which has received both Fast Track and Orphan Drug designations, is HUTCHMED's first oncology drug to potentially be marketed outside of China. The NDA is supported by promising data from Phase III studies in China and will also assist in a forthcoming application to the European Medicines Agency (EMA).

HUTCHMED has successfully listed its ordinary shares on the Main Board of the Stock Exchange of Hong Kong (SEHK) under the stock code '13'. Following the closing of its primary offering, the company raised approximately HK$4.17 billion from the issuance of 104 million new ordinary shares. The gross proceeds will be utilized for advancing late-stage clinical programs, expanding product portfolio, and strengthening integrated capabilities. Notably, cornerstone investors subscribed for 61% of the Offer Shares. The final offer price was set at HK$40.10 per share.

HUTCHMED (HCM) has announced a global offering of 104 million new ordinary shares priced at HK$40.10 per share, equating to approximately US$25.82 per American depositary share (ADS). This offering aims to amass gross proceeds of around HK$4.17 billion. The funds will primarily support late-stage clinical programs and enhance commercialization capabilities. Trading is expected to commence on the Hong Kong Stock Exchange on June 30, 2021. An over-allotment option allows the issuance of up to an additional 15.6 million shares, enhancing the company's capacity for future growth.

HUTCHMED announced that its oral MET inhibitor, savolitinib, received conditional approval from China's NMPA for treating non-small cell lung cancer (NSCLC) patients with MET exon 14 alterations. This marks the first global regulatory approval for savolitinib. The approval was based on a successful Phase II trial demonstrating effective tumor response. A confirmatory study is required for full approval. HUTCHMED's CEO emphasized the significance of this milestone as part of their collaboration with AstraZeneca, dating back to 2011, to advance targeted cancer therapies.

HUTCHMED announces that surufatinib has received approval from the National Medical Products Administration in China for treating advanced pancreatic neuroendocrine tumors (pNETs), following a previous approval for extra-pancreatic neuroendocrine tumors (epNETs) in December 2020. The approval was based on positive results from the Phase III SANET-p trial, which showed a 51% reduction in the risk of progression or death. With surufatinib marketed as Sulanda, the company plans to expand its oncology treatment reach in China, where there are an estimated 300,000 NET patients.