new option listings and two option delistings on April 7th » 08:3004/0704/07/21
ACIC, ASTS, CCV, ENTX, GATO, HCM, KBNT, NAPA, OLO, PCT, PDSB, SFTW, SHV, USFR, VTIP, NPA, PS
New option listings for…
New option listings for April 7th include Atlas Crest Investment Corp (Class A Stock) (ACIC), ARK Space Exploration and Innovation (ARKX), AST SpaceMobile Inc (Class A Stock) (ASTS), Churchill Capital Corp V (Class A Stock) (CCV), Entera Bio Ltd (ENTX), Gatos Silver Inc (GATO), Hutchinson China MediTech (HCM), Kubient Inc (KBNT), Roundhill Mvp Etf (MVP), Duckhorn Portfolio Inc (NAPA), Olo Inc (Class A Stock) (OLO), PureCycle Technologies Inc (PCT), PDS Biotechnology Corp (PDSB), Osprey Technology Acquisition Corp (Class A Stock) (SFTW), iShares Treasury (SHV), SVF Investment Corporation (Units) (SVFAU), SPDR DoubleLine Total Return Tactical ETF (TOTL), WisdomTree Bloomberg Floating Rate Treasury Fund (USFR), Janus Henderson Short Duration Income ETF (VNLA), Vanguard Short Term Inflation Protected Securities Index Fund (VTIP), and Vanguard International High Dividend Yield ETN (VYMI). Option delistings effective April 7th include New Povidence Acquisition Corporation (Class A Stock) (NPA) and Pluralsight Inc (Class A Stock) (PS).
|Over a week ago|
Hutchison China MediTech initiates two HMPL-306 studies » 05:3503/2903/29/21
Hutchison China MediTech…
Hutchison China MediTech has initiated two international Phase I studies of HMPL-306, its novel selective small molecule dual inhibitor of isocitrate dehydrogenase, or IDH, 1 and 2 mutations. One trial is in patients with advanced solid tumors and one trial is in patients with hematological malignancies. Both trials have sites in the U.S. and Europe. The first international patient was dosed on March 25 following a Phase I trial that was initiated in China in the second half of 2020. This new program is a demonstration of HUTCHMED's accelerating and expanding global clinical development presence. These two trials are multi-center studies to evaluate the safety, tolerability pharmacokinetics, pharmacodynamics and preliminary efficacy of HMPL-306. The first trial is in solid tumors, while a second trial is in advanced relapsed, refractory or resistant hematological malignancies that harbor IDH1 or IDH2 mutations. The first stage of each study is a dose escalation phase where cohorts of patients will receive ascending oral doses of HMPL-306 to determine the maximum tolerated dose and/or the recommended Phase II dose, or RP2D. The second stage is a dose expansion phase where patients will receive HMPL-306 to further evaluate the safety, tolerability, and clinical activity at the RP2D.
Hutchison China MediTech to divest non-core OTC joint venture for $169M » 09:3203/2403/24/21
Hutchison China MediTech…
Hutchison China MediTech announces that it has reached an agreement with GL Mountrose Investment Two to sell its entire indirect interest in Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited, a non-core and non-consolidated over-the-counter drug joint venture business. The aggregate amount to be received by HUTCHMED of approximately $169M in cash represents about 22 times HBYS' adjusted net profit attributable to HUTCHMED equity holders of $7.7M in 20201. Of the proceeds, approximately $127M is related to its shareholding in HBYS with the approximately $42M balance related to distributions of the previously announced land compensation and prior year undistributed profits. A deposit of $15.9M is payable by GL Capital immediately following signing of the agreement which will be credited against the proceeds due on closing of the transaction. The transaction is subject to regulatory approval in China and is expected to close in mid-2021.
Hutchison China MediTech initiates surufatinib, tislelizumab combination study » 05:1303/2403/24/21
Hutchison China MediTech…
Hutchison China MediTech (HCM) has initiated a Phase Ib/II study of surufatinib in combination with BeiGene's (BGNE) tislelizumab in patients with advanced solid tumors in the U.S. and Europe. The first patient was dosed on March 23. This trial is to explore potential synergistic activity of the novel, oral angio-immuno kinase inhibitor surufatinib with the anti-PD-1 antibody tislelizumab in enhancing overall antitumor activity from inhibition of angiogenesis along with stimulation of an immune response. This is an open-label study to evaluate the safety, tolerability, pharmacokinetics and efficacy of surufatinib in combination with tislelizumab in patients with advanced solid tumors. The study consists of two parts: dose finding and dose expansion. Part 1 will be conducted to determine the recommended Phase II dose, or RP2D, and/or the maximum tolerated dose of surufatinib in combination with tislelizumab in patients with advanced or metastatic solid tumors who have progressed on, or are intolerant to, standard therapies. Part 2 will be an open-label, multi-cohort design to evaluate the anti-tumor activity of surufatinib in combination with tislelizumab in patients with specific types of advanced or metastatic solid tumors, including neuroendocrine tumors, colorectal cancer, small cell lung cancer, gastric cancer, and soft tissue sarcoma. Patients will receive the RP2D determined in Part 1 of this study.
|Over a month ago|
Hutchison China MediTech announces name change to HUTCHMED » 09:0103/0403/04/21
The company said,…
The company said, "Today we announce the consolidation of the two corporate identities that we have used since our inception. Hutchison China MediTech, or Chi-Med, has been used as our group identity, while Hutchison MediPharma has been the identity of our novel drug R&D43 operations under which our oncology products have been developed and are now being marketed. We believe now is the right time to consolidate to a single and ubiquitous corporate identity that captures the history and brand equity we have built over the past twenty years. Therefore, we have chosen to rename ourselves HUTCHMED. The brand HUTCHMED will immediately replace Chi-Med as our abbreviated name. We plan to formally change our group company name at our Annual General Meeting in April 2021, and the names of our key subsidiary companies over the balance of 2021. Our ticker symbol, HCM, will remain unchanged on the Nasdaq Global Select Market and the AIM market of the London Stock Exchange. We have also changed our website to www.hutch-med.com. The information required pursuant to AIM Rule 26 may be found at this address."
Hutchison China MediTech sees 2021 oncology/immunology revenues $110M-$130M 09:0003/0403/04/21
Hutchison China MediTech reports 2020 EPS (18c) vs. (16c) last year » 08:5903/0403/04/21
Reports 2020 revenues…
Reports 2020 revenues $227.98M vs. $204.89M last year. "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."
Chi-Med, Inmagene partner to develop candidates to treat immunological diseases » 20:3101/1001/10/21
Hutchison China MediTech…
Hutchison China MediTech and Inmagene Biopharmaceuticals announced a strategic partnership to further develop four novel preclinical drug candidates discovered by Chi-Med for the potential treatment of multiple immunological diseases. Funded by Inmagene, the companies will work together to move the drug candidates towards investigational new drug submission. If successful, Inmagene will then move the drug candidates through global clinical development. Under the terms of the agreement, Chi-Med grants Inmagene exclusive options to four drug candidates solely for the treatment of immunological diseases. Should Inmagene exercise the option, it will have the right to further develop, manufacture and commercialize that specific drug candidate worldwide, with Chi-Med retaining first right to co-commercialization in mainland China. For each of the drug candidates, Chi-Med will be entitled to development milestones of up to $95M and up to $135M in commercial milestones, as well as up to double-digit royalties upon commercialization.
|Over a quarter ago|
Chi-Med announces NMPA approval of surufatinib » 07:0612/3012/30/20
Hutchison China MediTech…
Hutchison China MediTech announces that surufatinib has been granted approval for drug registration by the National Medical Products Administration of China for the treatment of non-pancreatic neuroendocrine tumors. Surufatinib will be marketed in China under the brand name Sulanda. Surufatinib is Chi-Med's first self-discovered oncology drug to be approved in China without the support of a development partner, and follows the approval of Chi-Med's first oncology drug, Elunate, in 2018. Chi-Med has established an oncology commercial team that today covers more than 2,000 hospitals across China. The team is led by a leadership team highly experienced in oncology products commercialization in China with deep knowhow in the field of NETs. The NMPA approval of Sulanda was based on results from the SANET-ep1 study, a Phase III trial in patients with advanced non-pancreatic NETs conducted in China. The study met the pre-defined primary endpoint of progression-free survival at a preplanned interim analysis. The positive results of this trial were highlighted in an oral presentation at the 2019 ESMO Congress and published in The Lancet Oncology in September 2020.2 Median PFS was significantly longer for patients treated with surufatinib at 9.2 months, compared to 3.8 months for patients in the placebo group. Surufatinib had an acceptable safety profile, with the most common treatment-related adverse events of grade 3 or worse being hypertension, proteinuria and anemia.
Chi-Med initiates rolling submission of NDA to FDA for surufatinib » 13:2912/2812/28/20
Hutchison China MediTech…
Hutchison China MediTech Limited, or Chi-Med, announced that it has initiated the filing of a New Drug Application, NDA, to the FDA - the first portion of a rolling submission for surufatinib for the treatment of pancreatic and non-pancreatic neuroendocrine tumors. Chi-Med plans to complete the NDA submission in the first half of 2021, which would be the company's first NDA in the U.S. The Fast Track Designation granted earlier this year by the FDA permits the company to submit sections of the NDA on a rolling basis. The NDA is supported by data from the two positive Phase III studies of surufatinib in NET in China, along with data from surufatinib studies in U.S. non-pancreatic and pancreatic NET patients. The data package will also be used to file a Marketing Authorization Application to the European Medicines Agency in 2021, based on scientific advice from the EMA's Committee for Medicinal Products for Human Use. The company plans to initiate an Expanded Access Protocol to ensure patients with limited therapeutic options have access to this important treatment. Enrollment into this early access program is anticipated to begin in Q1 of 2021, once regulatory clearance of the protocol has been granted by the FDA. The FDA granted two Fast Track Designations to surufatinib for development in pancreatic and non-pancreatic NET in April 2020 and Orphan Drug Designation for pancreatic NET in November 2019.