Hutchison China MediTech Ltd.

HUTCHMED (China) Ltd. is a holding company, which engages in the research and development, manufacture, and sale of pharmaceuticals and health oriented consumer products. It operates through the Oncology/Immunology and Other Ventures segments. The Oncology/Immunology segment covers all activities related to oncology/immunology including sales, marketing, manufacturing and research and development with respect to drugs and drug candidates. The Other Ventures segment includes all other HUTCHMED businesses. The company was founded on December 18, 2000 and is headquartered in Hong Kong.

HUTCHMED (China) Ltd. is a holding company, which engages in the research and development, manufacture, and sale of pharmaceuticals and health-oriented consumer products. It operates through the Oncology/Immunology and Other Ventures segments. The Oncology/Immunology segment includes the discovery, development, and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. The Other Ventures segment involves the other commercial businesses which include the sales, marketing, manufacture, and distribution of prescription drugs and healthcare products. The company was founded on December 18, 2000 and is headquartered in Hong Kong.

– Company plans to complete rolling submission in the first half of 2021 –

Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Dec. 22, 2020 (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces that Christian Hogg, Chief Executive Officer, will present at the 39th Annual JP Morgan Healthcare Conference taking place virtually on Monday January 11, 2021 at 8 a.m. EST (1 p.m. GMT / 9 p.m. HKT).

Chi-Med to Present at the 39th Annual JP Morgan Healthcare Conference

BeiGene

Pharmaceuticals is the only sector that has all three characteristics foreign investors are looking for in Chinese investments: an industry that will consolidate, pro-growth policy reform and support and innovation. So said John Yung, Citi head of Asia health care research, according to an article in the South China Morning Post.

Chinese Biotechs Warrant Investor Consideration

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Chi-Med Announces US$100 Million Equity Investment by CPP Investments

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that initial analysis of the first in human HMPL-689 Phase I dose escalation study will be presented as a poster at the upcoming 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place on December 5-8, 2020 virtually.

Chi-Med Highlights HMPL-689 Clinical Data to be Presented at the 62nd ASH Annual Meeting

― Phase III SANET-p demonstrated surufatinib reduces the risk of disease progression or death by 51% in patients with pancreatic neuroendocrine tumors (“NET”) ―

Chi-Med Highlights Surufatinib Phase III Results in Neuroendocrine Tumors at ESMO 2020 and Publications in The Lancet Oncology

HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., Sept.  17, 2020  (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“ Chi-Med ”) (Nasdaq/AIM: HCM) today announces that its New Drug Application (“NDA”) for surufatinib for the treatment of patients with advanced pancreatic neuroendocrine tumors (“NET”) has been accepted for review by the China National Medical Products Administration (“NMPA”).

Chi-Med Announces Second NDA Acceptance in China for Surufatinib in Pancreatic Neuroendocrine Tumors

HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., Sept.  04, 2020  (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“ Chi-Med ”) (Nasdaq/AIM: HCM) has initiated FRESCO-2, a Phase III registration study of fruquintinib for the treatment of patients with metastatic colorectal cancer (“CRC”) in the U.S., Europe and Japan. The first patient was dosed on September 3, 2020, in the U.S.

Chi-Med Initiates FRESCO-2, a Global Phase III Trial of Fruquintinib in Metastatic Colorectal Cancer

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Sept.  03, 2020  (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“ Chi-Med ”) (Nasdaq/AIM: HCM) has initiated a Phase II study of HMPL-453, its novel small molecule inhibitor targeting fibroblast growth factor receptors (“FGFR”), in patients with advanced intrahepatic cholangiocarcinoma (“IHCC”), which is a type of liver cancer.

Chi-Med Initiates a Phase II Trial of HMPL-453 in Patients with Advanced Intrahepatic Cholangiocarcinoma in China

HONG KONG and FLORHAM PARK, N.J., Aug.  24, 2020  (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“ Chi-Med ”) (Nasdaq/AIM: HCM) today announces that new and updated analyses on the studies of surufatinib and fruquintinib will be presented at the upcoming European Society for Medical Oncology (ESMO) Virtual Congress 2020, taking place on September 17-21, 2020.

Chi-Med Highlights Clinical Data to be Presented at the Upcoming ESMO Virtual Congress 2020

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug.  10, 2020  (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“ Chi-Med ”) (Nasdaq/AIM: HCM) today announces that it received scientific advice from the European Medicines Agency's (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) for surufatinib for the treatment of patients with advanced neuroendocrine tumors (“NET”).  Based on the CHMP advice, we have concluded that the completed SANET-ep (non-pancreatic NET) and SANET-p (pancreatic NET) studies, along with existing data from surufatinib in U.S. non-pancreatic and pancreatic NET patients, could form the basis to support a marketing authorization application (“MAA”).  Given that no filing issues were identified, the MAA submission is planned for 2021, following submission for the U.S. Food and Drug Administration (“FDA”) new drug application (“NDA”).

Chi-Med Plans to Submit Marketing Authorization Application for Surufatinib Following Scientific Advice from EMA’s CHMP

Hutchison China MediTech Limited (HCM) CEO Christian Hogg on Q2 2020 Results - Earnings Call Transcript

– Strong global pipeline progress – three U.S. FDA  1   Fast Track Designations; surufatinib U.S. NDA  2   preparations underway; and initiation of global Phase III for fruquintinib –

Chi-Med Reports 2020 Interim Results and Provides Updates on Key Clinical Programs

HONG KONG and FLORHAM PARK, N.J., July  28, 2020  (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“ Chi-Med ”) (Nasdaq/AIM: HCM) today announced that the China National Medical Products Administration (“NMPA”) has granted Priority Review status to the New Drug Application (“NDA”) for savolitinib for the treatment of non-small cell lung cancer (“NSCLC”) with MET Exon 14 skipping mutations.  This is the first NDA filing for savolitinib globally and first for a selective MET inhibitor in China.

Chi-Med’s NDA for Savolitinib in Non-Small Cell Lung Cancer Granted Priority Review in China

HONG KONG, SHANGHAI, and FLORHAM PARK, N.J., July  28, 2020  (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“ Chi-Med ”) (Nasdaq/AIM: HCM) and Eli Lilly and Company (“Lilly”) today announce an amendment to the 2013 License and Collaboration Agreement on Fruquintinib with Lilly Shanghai, an affiliate of Lilly.  The 2020 Amendment covers the expansion of Chi-Med’s role in the commercialization of Elunate® (fruquintinib capsules) in China.

Chi-Med and Lilly to Collaborate in Commercializing Elunate® in China

— HMPL-306 is the ninth innovative oncology drug candidate discovered in house by Chi-Med —

Chi-Med Initiates a Phase I Trial of IDH1/2 Dual Inhibitor in Patients with Hematological Malignancies in China

Chi-Med Announces US$100 Million Equity Investment by General Atlantic

LONDON, June  18, 2020  (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“ Chi-Med ”) (Nasdaq/AIM: HCM) today announces that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track Designation for the development of fruquintinib, for the treatment of patients with metastatic colorectal cancer (“mCRC”) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biological therapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy.

Chi-Med Announces Fruquintinib Granted U.S. FDA Fast Track Designation for Metastatic Colorectal Cancer

LONDON, June  09, 2020  (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“ Chi-Med ”) (Nasdaq/AIM: HCM) today announces that Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited (“HBYS”), its 50:50 joint venture with Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited, has today entered into an agreement (the “Agreement”) with the Guangzhou government for the planned return of HBYS’s remaining 34 years land-use rights on its approximately 30,000 square meters unused site (“HBYS Plot 2”) at Guang Cong Road, Tong He Town, Baiyun District, Guangzhou (the “Site”).

Chi-Med Announces US$95 million Guangzhou Land Compensation Agreement

LONDON, June  04, 2020  (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“ Chi-Med ”) (Nasdaq/AIM: HCM) today announces that the Independent Data Monitoring Committee (IDMC) of the FRUTIGA study of fruquintinib has completed a planned interim data review. Based on the preset criteria, the IDMC recommended that the trial continue.

Chi-Med Announces the Continuation of Phase III FRUTIGA Study of Fruquintinib in Second-Line Gastric Cancer in China Following a Planned Interim Data Review

LONDON, June  01, 2020  (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“ Chi-Med ”) (Nasdaq/AIM: HCM) today announces that it has held its pre-New Drug Application (“NDA”) meeting with the U.S. Food and Drug Administration (“FDA”) for surufatinib for the treatment of patients with advanced neuroendocrine tumors (“NET”).  Chi-Med has reached an agreement with the FDA that the completed SANET-ep (non-pancreatic NET) and SANET-p (pancreatic NET) studies, along with existing data from surufatinib in U.S. non-pancreatic and pancreatic NET patients, could form the basis to support a U.S. NDA submission. 

Chi-Med Plans to Submit NDA for Surufatinib Following Pre-NDA Meeting with the U.S. FDA

— First NDA filing of savolitinib globally —

Chi-Med Announces NDA Acceptance in China for Savolitinib in the Treatment of Non-Small Cell Lung Cancer with MET Exon 14 Skipping Mutations

LONDON, April  17, 2020  (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“ Chi-Med ”) (Nasdaq/AIM: HCM) today announces that the U.S. Food and Drug Administration (“FDA”) has granted two Fast Track Designations for the development of surufatinib, for the treatment of both advanced and progressive pancreatic neuroendocrine tumors (“NET”) and extra-pancreatic (non-pancreatic) NET in patients who are not amenable for surgery.

Chi-Med Announces Surufatinib Granted U.S. FDA Fast Track Designations for the Treatment of Both Pancreatic and Non-Pancreatic Neuroendocrine Tumors

LONDON, March  31, 2020  (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“ Chi-Med ”) (Nasdaq/AIM: HCM) has initiated a Phase II study of HMPL-453, its novel small molecule inhibitor targeting fibroblast growth factor receptors (“FGFR”), in patients with advanced malignant mesothelioma.

Chi-Med Initiates a Phase II Trial of HMPL-453 in Patients with Advanced Malignant Mesothelioma in China

Hutchison China MediTech Limited's (HCM) CEO Christian Hogg on Q4 2019 Results - Earnings Call Transcript

News for Hutchison China MediTech Ltd. Stock (HCM)