HiST Pharma Announces U.S. FDA Approval to Initiate Phase III Clinical Study With TC Cream – World’s First Botanical Small-Molecule Drug That Treats Psoriasis Vulgaris
HiST Pharma through its wholly-owned Psoriasis Research Institute of Guangzhou (PRIG) announces today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) TC Cream to launch a U.S.-based multicenter Phase III clinical study to treat patients with psoriasis vulgaris, following a previously completed Phase IIb trial (NCT03372811).
“The initiation of a Phase III clinical trial for our IND, approved by the FDA, is another key milestone for the company in the final stage of our world’s first botanical new drug development following a successful Phase IIb trial for the treatment of psoriasis." – Liping Yang, CEO of HiST Pharma
The upcoming randomized, double-blind, vehicle-controlled, multicenter study aims to demonstrate the superiority of a world first-in-class naturally-occurring botanical new drug over the vehicle in treating psoriasis vulgaris in a large U.S. population, in terms of efficacy and long-term safety.
“The initiation of a Phase III clinical trial of our IND in the U.S. is another key milestone for the company in the final stage of our world’s first botanical new drug development. It is based on a successful Phase IIb trial and benefits from an earlier multicenter clinical trial of an approved new drug by the National Medical Products Administration (NMPA) in China for the treatment of psoriasis,” said Liping Yang, Chief Physician, Managing Director of PRIG, and CEO of HiST Pharma. “Our IND, TC Cream, offers a new topical option to treat psoriasis patients with breakthrough therapy targeting multiple autoimmune signaling pathways, aiming to address patients’ unmet medical needs and improve their long-term quality of life. With the clinical clearance from the FDA, we are one step closer to bringing TC to benefit millions of patients affected by this debilitating disease. We hope that TC will become the world’s first botanical drug serving as a first-line topical treatment for psoriasis and the third botanical drug ever approved for marketing by the FDA.”
HiST Pharma is planning to continue its global licensing strategy with biotech pharma partners to further leverage the product's market potential.
Psoriasis Research Institute of Guangzhou (PRIG), a wholly-owned research institute of HiST Pharma, was founded in 2008 in Guangzhou, China. PRIG has been developing TC, a botanical-based small-molecule drug since 2008. Compared to the existing therapeutic drugs, TC has a novel and different mechanism to treat psoriasis vulgaris and clinical treatment characteristics of rapid onset, good efficacy, and minimal side effects.
In its Phase IIb clinical study in the U.S., NCT03372811, TC demonstrated its superior efficacy over the vehicle under an 8-week regimen, and an excellent safety and tolerability profile owning to its multi-target and multi-system immunomodulation property that simultaneously promotes anti-inflammatory and blocks pro-inflammatory mediators. PRIG is currently preparing to launch the Phase III study in the U.S.
- Headquarter: Guangzhou, China
- Website: www.HiSTPharma.com
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230516005570/en/
For further information about PRIG / HiST Pharma:
Prof. Liping Yang, Managing Director and CEO
Tel: +86 20-32215437
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
SmartStream Launches Latest Solution for Onboarding Cash Balances Faster With AI-Enabled Technology6.6.2023 10:53:00 EEST | Press release
SmartStream, the financial Transaction Lifecycle Management (TLM®) solutions provider, today announces the latest version of SmartStream Air – with new AI functionality to onboard cash balances faster and more accurately, whilst further improving cash reconciliations. A new development team was set up to research and provide the new functionality in partnership with clients. If cash balances and/or positions are not managed correctly they will eventually lead to errors, financial losses, and even regulatory penalties. The key USP for SmartStream Air version 8 is for quick and easy onboarding of cash balances. The latest solution will continue to leverage its AI-enabled technology and exception management capabilities to provide users with the confidence to manage cash balances instantly. It is a great addition for existing clients, whilst providing a competitive advantage by outperforming slow, expensive, and ineffective systems. Jethro MacDonald, Head of Product Management – AI and Ma
Chatham Hires Jennifer McLellan as a Managing Director in Global ISDA and Regulatory Practice6.6.2023 10:00:00 EEST | Press release
Chatham Financial, a global leader in financial risk management advisory and technology solutions, is pleased to announce Jennifer McLellan is joining the company as a Managing Director in the global OTC derivative instruments, ISDA and regulatory practice. Jennifer established a leading practice in 2011 for law firm Dickson Minto, where she was the Head of Derivatives before joining Chatham. She has advised private equity sponsors, their portfolio investments, UK listed and private corporates, and an array of investment fund boards and managers on the end-user legal and regulatory issues around derivatives. Jennifer brings hands-on knowledge in navigating complicated cross-border M&A leveraged deals, including some of the largest European LBOs. She has advised on all stages of the deal lifecycle including diligence, deal contingent structures, running competitive multi-bank interest rate and FX hedging processes, as well as financial restructuring. On the funds side, Jennifer has a we
Intelsat To Deliver 2Ku Connectivity Upgrade to Japan Airlines6.6.2023 10:00:00 EEST | Press release
Intelsat, operator of the world’s largest integrated satellite and terrestrial network and leading provider of Inflight Connectivity (IFC) services, has reached an agreement with long-time customer Japan Airlines (JAL) to upgrade about 50 Boeing 737s and 767s to the company’s 2Ku inflight connectivity solution. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230606005202/en/ Intelsat To Deliver 2Ku Connectivity Upgrade to Japan Airlines (Photo: Business Wire) “We value the trust that JAL has placed in Intelsat throughout our 10-year relationship,” said Dave Bijur, senior vice president of Commercial for Intelsat Commercial Aviation. “JAL was Intelsat’s first non-U.S. commercial aviation customer, and we look forward to continuing to support JAL’s market-leading inflight connectivity service in Japan where their guests enjoy free service.” In addition to the fleet of Boeing 737s and 767s, JAL’s subsidiary airline, J-AIR Co. Lt
Discover® Global Network Study Finds 93% of Global Fintechs Increased Reliance on Payment Networks Given the Current Economic Environment6.6.2023 08:02:00 EEST | Press release
Today, Discover shared a portion of the third annual Fintech State of the Union , the most comprehensive study of its kind in the industry, providing global perspectives from consumers, fintech vendors, and venture capitalists. The research study commissioned by Discover Global Network with 451 Research of S&P Global Market Intelligence surveyed global fintechs to identify emerging digital payments trends shaping the fintech ecosystem. Reliance on Payments Networks is Strong for Fintechs Per the study, fintechs are dependent on payments networks, with 93% saying the current economic environment has increased their business’s reliance on payments networks. Fintechs are looking for payments partners who are flexible (44%) and innovative (44%). Fintechs also say they benefit from payment networks the most through financial investment (42%), access to customers (38%), and technology enablement (38%). “As a payments network, it’s exciting to see both fintechs and venture capitalists lean in
Carbios Aims to be a Leader in Growing r-PET Market with an Ambition to Capture 8 to 12% Share by 2035 Through Licensing Model6.6.2023 07:45:00 EEST | Press release
Regulatory News: Carbios (Euronext Growth Paris: ALCRB), a biotech company pioneer in the development and industrialization of biological technologies to reinvent the life cycle of plastic and textiles, will hold its 2023 Strategic Update today at 2pm CET in which it provides details of its business model for 2030 and 2035. Carbios announces its ambition to be a leading player in the global r-PET market by capturing between 4 and 8% of market share by 2030 and between 8 and 12% by 2035. CLICK HERE TO JOIN THE WEBCAST AT 2pm CET OR TO VIEW THE REPLAY Emmanuel Ladent – Chief Executive Officer and the Carbios Leadership team 6 June 2023, from 2pm CET to 4pm CET (Paris Time) https://edge.media-server.com/mmc/p/u2qw4cir France Dial-in: +33 170918704 / UK Dial-in: +44 1 212818004 1. A VALUE-CREATING BUSINESS MODEL Carbios’ business model, based on the licensing of its unique PET biorecycling technology2, relies on a CapEx lean approach and 3 sources of revenue (upfront payments and two recur
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom