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

HUTCHMED and AstraZeneca have launched a Phase II study of ORPATHYS® (savolitinib) for treating advanced MET amplified gastric cancer. The trial, initiated on July 27, 2021, aims to assess efficacy, safety, and pharmacokinetics with a focus on objective response rate (ORR). This follows the successful VIKTORY trial, which reported a 50% ORR. MET amplification is found in 4-6% of gastric cancer patients, with about 24,000 cases annually in China. ORPATHYS® is already marketed in China for non-small cell lung cancer with specific MET alterations.

HUTCHMED (HCM) announced the end of the stabilization period for its Global Offering on July 23, 2021. Morgan Stanley Asia Limited acted as the Stabilizing Manager, undertaking stabilizing actions that included over-allocations of 15,600,000 Offer Shares, representing about 15% of the total Offer Shares. Additionally, these shares were borrowed to cover over-allocations. The Over-allotment Option was fully exercised on July 12, 2021. No market purchases were made for price stabilization during this period. For detailed information, refer to the company’s announcement from July 12, 2021.

The European Medicines Agency (EMA) has accepted HUTCHMED's marketing authorization application for surufatinib, aimed at treating neuroendocrine tumors (NETs). This follows recent FDA NDA acceptance in the U.S. for the same indication. Surufatinib offers a dual mechanism to inhibit tumor growth by targeting specific receptors. Positive results from two Phase III studies in China support the application, indicating a growing potential market as the drug is already launched in China.

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.