BioInvent International
10.12.2021 13:18:53 CET | ACCESS Newswire | Press release
LUND, SE / ACCESSWIRE / December 10, 2021 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV) , a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), China's medical product regulator, has approved a Clinical Trial Application (CTA) submitted by BioInvent's licensee in China, CASI Pharmaceuticals (CASI). The CTA is for the initiation of two clinical trials of BioInvent's novel anti-FcyRIIB antibody, BI-1206, in patients with non-Hodgkin's Lymphoma (NHL) in China.
BI-1206 is BioInvent's lead drug candidate and is currently being investigated in two Phase 1/2 trials. One is evaluating the BI-1206 combination with anti-PD1 therapy Keytruda® (pembrolizumab) in solid tumors, and the other in combination with rituximab for the treatment of non-Hodgkin's lymphoma.
CASI is planning Phase 1 trials of BI-1206 as a single agent with the aim to evaluate the PK profile and in combination with rituximab in NHL (mantle cell lymphoma, marginal zone lymphoma and follicular lymphoma) to assess safety and tolerability, select the Recommended Phase 2 Dose and assess early signs of clinical efficacy as part of its development program for BI-1206 in China and associated markets. The studies are expected to start in H1 2022.
BioInvent and CASI have an exclusive licensing agreement for the development and commercialization of BI-1206 in mainland China, Taiwan, Hong Kong and Macau in both liquid and solid cancers, with CASI responsible for commercialization in China and associated markets. BioInvent is eligible to receive up to $83 million in development and commercial milestone payments plus tiered royalties in the high-single to mid-double-digit range on net sales of BI-1206.
"We are very pleased to see the first fruit of our development collaboration with CASI on BI-1206. As BioInvent develops the drug candidate across Europe and the US, our partnership with CASI focusing on China, Hong Kong, Macau and Taiwan, adds significant shareholder value to the company. Our expanding pipeline of first-in-class immunotherapies creates multiple development and commercial opportunities for the company and its partners." said Martin Welschof, CEO of BioInvent.
"We are excited to be able to accelerate the development of BI-1206 in China and contribute to its global development. The collaboration has been open, fast, efficient and professional. We believe BI-1206 has great potential to improve NHL treatment in China and elsewhere." said Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer.
About BioInvent
BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently three drug candidates in four ongoing clinical programs in Phase l/ll trials for the treatment of hematological cancer and solid tumors, respectively and a fifth program just initiating clinical development. The Company's validated, proprietary F.I.R.S.T™ technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company's own clinical development pipeline or for additional licensing and partnering.
The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com .
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. (NASDAQ:CASI) is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the Greater China market leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd. ("CASI China"), which is located in Beijing, China. The Company has built a commercial team of over 100 hematology and oncology sales and marketing specialists based in China. More information on CASI is available at www.casipharmaceuticals.com .
For further information, please contact:
Cecilia Hofvander
Senior Director Investor Relations
+46 (0)46 286 85 50
cecilia.hofvander@bioinvent.com
BioInvent International AB (publ)
Co. Reg. No. Org nr: 556537-7263
Visiting address: Ideongatan 1
Mailing address: 223 70 LUND
Phone: +46 (0)46 286 85 50
www.bioinvent.com
SOURCE: BioInvent International
View source version on accesswire.com:
https://www.accesswire.com/676974/BioInvent-and-CASI-Pharmaceuticals-Announce-CTA-Approval-for-Clinical-Studies-of-BI-1206-in-NHL-in-China
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.
About ACCESS Newswire
Subscribe to releases from ACCESS Newswire
Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from ACCESS Newswire
Chervon Promotes Kevin Gee to Vice President of Pro Product Development - FLEX28.9.2026 14:25:00 CEST | Press release
NAPERVILLE, IL / ACCESS Newswire / September 28, 2026 / Chervon promotes Kevin Gee to Vice President of Pro Product Development - FLEX, effective Monday, September 28, 2026, reporting to CEO Joe Galli. Kevin Gee joined Chervon after a 15-year international career in the Milwaukee Pro Power Tool business. He started his career at TTI in 2011 as a Field Sales Store Representative in Toronto, Ontario. He moved through several Milwaukee marketing positions in Canada and was then promoted to a marketing position with Milwaukee based in Hong Kong in 2013. He then rose to the position of Group Marketing Manager in Milwaukee Asia in 2016. In 2017, Kevin was moved to Milwaukee U.S.A. and advanced through a series of Milwaukee product management positions from 2017 to 2023. His final position was Director of Product Management for Milwaukee Pro Tools from 2021 to 2023. Most recently, Kevin held the position of Chief Revenue and Marketing Officer for Guardian Safety Equipment before joining Cherv
Chervon Names Trevor Bithrey Vice President Pro End User Marketing and Research - Canada28.9.2026 14:25:00 CEST | Press release
NAPERVILLE, IL / ACCESS Newswire / September 28, 2026 / Trevor Bithrey joins Chervon as Vice President, Pro End User Marketing and Research - Canada, effective Monday, September 28, reporting to CEO Joe Galli. Bithrey joins Chervon with over 25 years of professional power tools experience. He has excelled in his increasingly responsible positions in building both the DeWalt Canada business and the Milwaukee Canada business. He brings an impressive and diverse skillset in account management, end user marketing, aftersales service and end user research. He also has experience building and leading exceptional teams in Canada. Bithrey will also be part of the newly formed Chervon Global End User Research and Jobsite Marketing team, reporting directly to CEO Joe Galli. Bithrey's career started at DeWalt Canada where he held a series of sales and product management positions from 2000 to 2007. He then moved to Milwaukee Canada from 2007 until 2023 where he advanced through key leadership rol
Fermi Selects NAES to Operate and Maintain Its Natural Gas Turbine Fleet28.9.2026 13:00:00 CEST | Press release
DALLAS, TX / ACCESS Newswire / September 28, 2026 / Fermi Inc. (NASDAQ:FRMI)(LSE:FRMI), operating as Fermi America™ ("Fermi" or the "Company"), announced today an operations and maintenance (O&M) agreement with NAES Corporation ("NAES"), the largest independent operator of power plants in the United States. Under the agreement, NAES will run and maintain Fermi's natural gas turbine fleet at its Project Matador private-power campus in Carson County, Texas. "This agreement puts a proven and experienced operator in place that has been running power plants for more than 45 years," said Lee McIntire, Fermi Chief Executive Officer. "Our first customer is signed, our turbines are secured, and our EPC partners are on board. Now, with NAES, we're adding an operating partner with operations and maintenance depth, skilled crews, and proven management systems before the first natural-gas generation units come online. That protects uptime for the customers who are counting on us for quality and rel
Camino Receives Environmental Approval for Significant Exploration Expansion at the Costa de Cobre Copper Project in Peru28.9.2026 12:00:00 CEST | Press release
VANCOUVER, BC / ACCESS Newswire / September 28, 2026 / Camino Minerals Corporation (TSXV:COR)(OTCID:CAMZF) ("Camino" or the "Company") is pleased to announce that its Peruvian subsidiary, a 65/35 joint venture between Camino and Nittetsu Mining Co., Ltd. ("Nittetsu"), has received approval from Peru's Ministry of Energy and Mines ("MINEM") for the Second Modification of the Semi-Detailed Environmental Impact Assessment ("Second MEIA-sd") for its Costa de Cobre Project (formerly known and referred to in the permit as Los Chapitos), along the coastline in southern Peru. The approval represents a major milestone for Costa de Cobre, increasing the effective exploration area by approximately 94%, from 6,012.50 hectares to 11,671.90 hectares, and expanding the environmental framework to support a total of 280 drill platforms and up to 611,840 metres of drilling capacity, covering major portions of the three copper fault trends crossing Camino's claims: Diva trend; La Estancia trend; and the
Case IQ Launches Quantum Approvals & Disclosures So Compliance Teams Find Risk Earlier28.9.2026 10:00:00 CEST | Press release
LONDON, GB / ACCESS Newswire / September 28, 2026 / Case IQ, a leading provider of compliance and risk management solutions, today announced the launch of Quantum Approvals & Disclosures, a native AI-powered solution designed to help organisations identify risk earlier, reduce manual effort, and make more consistent, defensible compliance decisions. In addition to the embedded governed AI capabilities that support employees and compliance reviewers, the solution launches with two ready-to-use AI agents, Submission Support and Risk Spotlight. Employees receive intelligent guidance that helps them submit more complete and accurate information, while compliance teams gain the context needed to prioritise higher-risk activity and proactively engage before potential issues escalate. The solution supports complex approval and disclosure programmes spanning conflicts of interest, gifts and hospitality, donations and sponsorships, and other risk areas. By bringing submissions, reviews, decisio
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