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
GA-ASI Mojave First UAS To Complete Battlefield Short Field Ops16.9.2026 19:30:00 CEST | Press release
Short Takeoff and Landing Aircraft Validates Austere Field Capabilities SAN DIEGO, CA / ACCESS Newswire / September 16, 2026 / General Atomics Aeronautical Systems (GA-ASI) and Hanwha Aerospace have completed the first-ever flight operations from a simulated battlefield by a medium altitude, long endurance uncrewed aircraft. The partners proved that the Mojave Short Takeoff and Landing aircraft, or Mojave STOL, could land at a tank and artillery live-fire range during simulated combat conditions and then take off again to continue the mission. "This demonstration showcased Mojave's ability to perform tactical missions that are representative of real battlefield requirements and challenges," said GA-ASI CEO Linden Blue. "Whether the user needs contested and austere battlefield operations, ISR, weapons delivery, Air-Launched Effects deployment, troop resupply, counter-UAS, or missions requiring short and unimproved roads for takeoff, our aircraft answer the bell." "This demonstration mar
Freedom Holding Corp. Named General Partner of the Salesforce FIDE World Championship Match 202616.9.2026 16:13:00 CEST | Press release
Partnership builds on Freedom's long-term support for international chess as Geneva prepares to host the historic Gukesh - Sindarov title match NEW YORK CITY, NY / ACCESS Newswire / September 16, 2026 / Freedom Holding Corp. (NASDAQ:FRHC) will serve as General Partner of the Salesforce FIDE World Championship Match 2026, continuing a long-standing partnership with the International Chess Federation (FIDE) spanning elite competition, education and chess development. Freedom's involvement in the 2026 World Championship follows several years of cooperation with FIDE. The company was General Partner of the 2023 World Championship Match in Astana and title sponsor of the 2024 FIDE World Rapid & Blitz Championships in New York, one of FIDE's flagship global events. It has also supported international competitions and initiatives focused on expanding access to chess, developing young talent and strengthening the wider chess ecosystem. Earlier this year, Freedom and FIDE further expanded their
Xenetic Biosciences and Santersus AG Announce Definitive Share Exchange Agreement to Create Global Leader in NET-Targeting Therapeutics16.9.2026 13:00:00 CEST | Press release
Transaction expected to create a Nasdaq-listed, multi-indication clinical-stage company focused on targeting neutrophil extracellular traps (NETs), a driver of disease across critical care, autoimmune disease, transplantation and oncology Union of two companies brings together Santersus' NucleoCapture® technology, designed to physically remove NETs from circulation, with Xenetic's DNase technology, designed to enzymatically degrade NETs in tissue Joint pipeline includes four first-in-class programs, including pivotal-stage programs in sepsis and systemic lupus erythematosus (SLE), both of which have received FDA Breakthrough Device Designation Companies to host Business Update Conference Call and Webcast Today, Wednesday, September 16th at 8:30 AM ET FRAMINGHAM, MA / ACCESS Newswire / September 16, 2026 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic"), a biopharmaceutical company advancing its Deoxyribonuclease ("DNase") technology, and Santersus AG ("Santersus"), a privately held
DataTracks Completes First Live GloBE Filing Cycle, Delivering Close to 500 Pillar Two Filings Across 10+ Jurisdictions16.9.2026 11:15:00 CEST | Press release
HMRC-authorised provider completes close to 500 Pillar Two filings, including more than 150 GIRs, for 160+ clients across 10+ jurisdictions WEYBRIDGE, GB / ACCESS Newswire / September 16, 2026 / DataTracks, recognised by HMRC as an authorised software provider supporting UK Pillar Two submissions, has completed its first live BEPS Pillar Two filing cycle, delivering close to 500 filings, including more than 150 GIRs, across 10+ jurisdictions for more than 160 clients. The milestone caps two decades of work in regulatory reporting. The cycle spanned GloBE Information Returns (GIR), domestic top-up tax returns under local QDMTT (Qualified Domestic Minimum Top-up Tax) regimes, UK Overseas Return Notifications (ORNs), and other jurisdiction-specific returns and notifications. Several jurisdictions in this cycle, including the Netherlands and Luxembourg, require similar notifications confirming where the GIR was filed centrally, under their own local terms. DataTracks filed each return dire
Hydrosat Unveils Osiris Constellation, The Future of Thermal Intelligence16.9.2026 08:00:00 CEST | Press release
Next-generation satellite constellation will combine high-resolution thermal imaging with broad-area coverage and daily revisit to support governments, businesses, and researchers worldwide. PARIS, FR / ACCESS Newswire / September 16, 2026 / Hydrosat, the leading provider of thermal infrared satellite data and AI-powered analytics, today announced Osiris, its next-generation Earth observation constellation designed to deliver wide-area, high resolution intelligence for water and food security, critical infrastructure, and national security missions. At the core of each Osiris satellite is Hydrosat's next-generation thermal infrared payload, developed to collect high-resolution thermal data across exceptionally wide areas. Operating across three longwave infrared bands, the payload will capture imagery at 25-meter native resolution over 160-kilometer to 340-kilometer swath widths, addressing one of Earth observation's biggest challenges between spatial detail and collection scale. This
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