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
Aehr Test Systems Appoints Former Meta Infrastructure Executive Vijay Rao to Board of Directors29.10.2026 12:30:00 CET | Press release
FREMONT, CA / ACCESS Newswire / October 29, 2026 / Aehr Test Systems (NASDAQ:AEHR), a leading provider of test and burn-in solutions for semiconductor devices used in artificial intelligence (AI), silicon photonics, data center, automotive, and industrial applications, today announced the appointment of Vijay Rao to its Board of Directors, effective October 28, 2026. Rao brings 30 years of technology industry experience, including more than 13 years at Meta, where he most recently served as Vice President of Infrastructure. His experience spans infrastructure strategy, AI computing, and semiconductor technologies in hyperscale, enterprise, and startup environments. "Vijay brings deep expertise in infrastructure requirements of hyperscale data centers, including the integration of AI accelerators, high-performance memory, and optical networking," said Gayn Erickson, President and Chief Executive Officer of Aehr Test Systems. "He understands firsthand how semiconductor quality and reliab
U.S. Polo Assn. Executes Early on Europe's Digital Product Passport Mandate29.10.2026 12:00:00 CET | Press release
WEST PALM BEACH, FL / ACCESS Newswire / October 29, 2026 / U.S. Polo Assn.®, the official sports brand of the United States Polo Association (USPA), with a multi-billion-dollar global footprint and distribution in more than 190 countries through some 1,200 U.S. Polo Assn. mono-brand retail stores, numerous branded websites and thousands of other points of distribution worldwide, today announced the brand's early activation of Digital Product Passports (DPPs) across product categories sold into the European Union (EU). As Europe prepares to launch the Digital Product Passport Registry, U.S. Polo Assn. has taken a proactive approach by preparing to deploy DPPs across all products sold into the EU well ahead of the mandatory compliance deadline expected in 2028 or 2029. The global sports brand has already mapped product information for millions of products, creating a scalable framework that will enhance product transparency and support compliance readiness throughout its European operati
LiberNovo Previews Treat Yourself Halloween Flash Sale Across Europe29.10.2026 08:40:00 CET | Press release
HONG KONG, HK / ACCESS Newswire / October 29, 2026 / LiberNovo is bringing Halloween treats to the desk with its Treat Yourself Halloween Flash Sale, opening October 29 across the European Union and United Kingdom. The event pairs savings of up to 40% on selected Maxis and LiberNovo Omni Pro configurations with limited seasonal gifts for qualifying early shoppers. Spooky extras for your desk Limited Halloween-themed gift packs are available to the first 300 eligible customers in the European Union and the first 100 in the United Kingdom, on a first-come, first-served basis while supplies last. Gift contents, qualifying purchases and availability follow the terms on each regional campaign page. More room for Big and Tall users Maxis is designed around larger frames, with a wider seat and 52 cm seat depth for greater thigh support and room to shift naturally. Maxis Manual provides adjustment by hand. Maxis Electric adds motorised lumbar adjustment and OmniStretch guided back stretching.
IAVI Awarded $36 Million From BARDA for Bundibugyo Virus Vaccine Development28.10.2026 16:50:00 CET | Press release
NEW YORK, NY, SINGAPORE, SG INCHEON, SOUTH KOREA, AND DESSAU-ROSSLAU, DE / ACCESS Newswire / October 28, 2026 / Today IAVI, a global nonprofit biomedical research organization, together with partners Hilleman Laboratories, SK bioscience, and IDT Biologika announced that IAVI has been awarded US $36 million of a contract valued up to US $99 million from the Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, to advance development, manufacturing, and clinical evaluation of its one-dose vaccine candidate against Bundibugyo virus (BDBV), the cause of the ongoing Ebola epidemic in the Democratic Republic of the Congo (DRC). The award supports manufacturing of vaccine doses for clinical evaluation and outbreak response, clinical and regulatory activities including a Phase 1 trial, and options for expanded manufacturing to support future preparedness needs, as
GA-ASI and Saab Perform Advanced AEW Flight Testing on Uncrewed MQ-9B28.10.2026 16:00:00 CET | Press release
SAN DIEGO, CA / ACCESS Newswire / October 28, 2026 / General Atomics Aeronautical Systems, Inc. (GA-ASI) has partnered with Saab to perform advanced flight testing of an Airborne Early Warning (AEW) system on an Uncrewed Aircraft System (UAS). The flight testing was conducted over the past few months using a GA-ASI-produced MQ-9B carrying a Saab LoyalEye radar operating from GA-ASI's Desert Horizon flight operations facility in Southern California. The flight test demonstrated simultaneous tracking of several airborne and maritime targets at long ranges. The airborne targets tracked included multiple instrumented red fighter jets and several commercial aircraft. MQ-9B is GA-ASI's flagship UAS, offering unmatched endurance, type certification and all-weather performance. GA-ASI is discussing unmanned AEW capabilities on MQ-9B with several customers. "This has been one of the most highly anticipated flight tests we have performed," said GA-ASI President David R. Alexander. "The level of
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