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
Karbon-X Announces Strategic Partnership to Evaluate Kenya BioHub Initiative8.7.2026 15:00:00 CEST | Press release
Company to conduct feasibility assessment for integrated land restoration and renewable energy initiative as part of its strategy to expand its international climate project development pipeline. CALGARY, AB / ACCESS Newswire / July 8, 2026 / Karbon-X Corp. (OTCQB:KARX) ("Karbon-X" or the "Company"), a vertically integrated climate solutions company delivering end-to-end services across global carbon markets and climate infrastructure, today announced a strategic partnership with REGID International ("REGID") to jointly evaluate the Kenya BioHub Initiative, an integrated climate infrastructure program designed to restore degraded land, produce sustainable biomass, and support industrial decarbonization in Kenya. The partnership reflects Karbon-X's disciplined approach to identifying, evaluating, and selectively advancing climate infrastructure opportunities with long-term development potential as part of its strategy to expand its international project development pipeline. The Kenya B
Frame Security Launches KnowBetter as AI Reshapes Social Engineering8.7.2026 14:00:00 CEST | Press release
AI Is Rewriting the Social Engineering Playbook. Security Awareness Training Hasn't Caught Up. Organizations must KnowBetter. NEW YORK CITY, NY / ACCESS Newswire / July 8, 2026 / Security teams have spent two decades training employees to spot a familiar set of red flags: a suspicious link, a misspelled domain, an urgent request for a wire transfer. That approach is now colliding with an attacker toolkit that has changed faster than most awareness programs have. Generative AI has made it possible to clone a voice from a few seconds of audio, generate a passable deepfake video in minutes, and write a phishing email tailored to a specific employee's role, manager, and recent LinkedIn activity. Vishing calls, smishing texts, and video-based impersonation are now standard components of enterprise social engineering campaigns, not edge cases. "Most organizations are still training people to recognize threats from five years ago," said Tal Shlomo, co-founder and CEO of Frame Security, a huma
GoodData.AI Brings Governed Agentic Analytics to Regulated Enterprises Across DACH8.7.2026 13:05:00 CEST | Press release
GoodData.AI lets regulated enterprises in Germany, Austria, and Switzerland build and govern AI agents that support business processes, while maintaining full control over where AI runs and what data it can access. SAN FRANCISCO, CA / ACCESS Newswire / July 8, 2026 / GoodData.AI, an open agentic analytics platform with nearly two decades of analytics experience, today announced an expanded investment in the DACH region, bringing governed agentic analytics to regulated enterprises across Germany, Austria, and Switzerland. Many regulated enterprises have held off on production AI because outputs can't be traced back to approved business logic. GoodData.AI's platform addresses that directly: agents stay on a process over time, drafting and updating reports, analyses, and recommendations as new data comes in, while every output stays grounded in logic the company has already approved and can show an auditor on request. The EU AI Act has introduced some of the most comprehensive AI governan
Polaris Announces Execution of Mixed Investment Agreement for the Three Mexico Projects7.7.2026 13:50:00 CEST | Press release
TORONTO, ON / ACCESS Newswire / July 7, 2026 / Polaris Renewable Energy Inc. (TSX:PIF) ("Polaris" or the "Company") is pleased to announce that, further to its press release dated June 8, 2026, it has reached another important milestone in the development of its three renewable energy projects selected under Mexico's Comisión Federal de Electricidad ("CFE") Mixed Development Program (the "Mixed Program"). On July 3, 2026, Polaris, through its Mexican project structure, executed the Mixed Investment Agreement (Contrato de Inversión Mixta or "CIM") with the fiduciary trustee, Banca Mifel, S.A., Institucion de Banca Multiple, Grupo Financiero Mifel, acting on behalf of CFE. The CIM establishes the contractual 30-year framework governing the joint participation of Polaris and CFE in the development, financing, construction, ownership and operation of the three selected projects, including the applicable governance, economic and corporate arrangements. The CIM includes the key information a
Oxford University Press Comes to Simply Piano7.7.2026 10:00:00 CEST | Press release
Content from OUP's acclaimed piano method is now available to millions of Simply Piano learners worldwide NEW YORK, NY / ACCESS Newswire / July 7, 2026 / Simply, the leading digital platform for creative hobbies, today announced an agreement to bring content from Oxford University Press' (OUP) piano method to Simply Piano. This expands Simply Piano's offering and marks a step forward in its mission to make the pursuit of creative hobbies simple and fun for all. Simply Piano users around the world will gain access to an expanded library of high-quality, curated sheet music spanning OUP's works including Piano Time and Tunes for Ten Fingers, all within the app's interactive learning environment. The integration expands Simply Piano's sheet music library across genres, complementing its step-by-step courses and real-time feedback tools. "Access to songs people love is one of the strongest drivers of learning," said Yuval Kaminka, CEO & co-founder of Simply. "Working with OUP allows us to
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