TMS Co., Ltd.

Ji Xing Pharmaceuticals acquired global rights to Biogen’s acute ischaemic stroke treatment on Friday, following a pause in its development last year.The Chinese drug developer, which is mostly focused on cardiovascular diseases, will pay undisclosed upfront and milestone payments for BIIB131, a small molecule plasminogen activator designed to break down blood clots and inhibit local inflammation at the site of thrombosis. Biogen has said this combination could allow for an extended treatment window compared to existing thrombolytic agentsHowever, last April, Biogen decided to pause the initiation of a Phase IIb study of BIIB131 as part of a wider pipeline trim. The company paid $22 million for an option and subsequent licensing of BIIB131 from Japanese drugmaker TMS in 2021.

BIIB 131 is aimed at treating acute ischemic stroke (AIS) patients. Credit: CGN089/Shutterstock.com. Ji Xing Pharmaceuticals has acquired Biogen ’s investigational drug, BIIB 131, aimed at advancing worldwide clinical development to treat AIS. BIIB 131’s mechanism of action focuses on restoring blood flow after an acute stroke, which could lead to improved patient outcomes. The drug, which has shown potential in a Phase II trial in Japan, has both thrombolytic and anti-inflammatory properties, potentially extending the treatment window beyond existing standards. Subjects who received BIIB 131 demonstrated substantially better clinical outcomes at 90 days compared with those who were treated with a placebo. These results were supported by additional safety and angiographic data. The terms of the acquisition include an undisclosed upfront payment as well as payments on meeting milestones and royalty payments on worldwide product sales. Ji Xing Pharmaceuticals CEO and board executive director Sandy Mou stated: “BIIB 131 represents a potential breakthrough for a critical condition (AIS) that has not seen any meaningful pharmacologic innovation for almost 30 years. “We hope to prove that BIIB 131 will significantly improve clinical outcomes for AIS patients around the world. “This acquisition will not only enrich JIXING’s pipeline, but also accelerate the execution of our globalisation strategy.” Ji Xing has also entered a strategic partnership with TMS, following the assignment of an option agreement from Biogen to Ji Xing. This will see TMS and Ji Xing join forces on the global development of TMS-007, another new treatment for AIS. TMS will retain royalty-free rights in Japan, while Ji Xing will spearhead its development and commercialisation in other countries. In a Phase IIa trial of TMS-007 in Japan involving 90 patients with AIS, the small molecule has shown statistically significant difference over placebo on a key efficacy endpoint. The proportion of subjects with a modified Rankin Scale 0-1 (no or minimal symptoms) at day 90 was the efficacy goal. Ji Xing has also licensed exclusive rights for JX09 to TMS in Japan. JX09, an oral treatment for resistant and/or uncontrolled hypertension, is expected to enter Phase I clinical trials in 2024.

Jixing Pharmaceuticals will develop investigational drug globally SHANGHAI, China I January 11, 2024 I Ji Xing Pharmaceuticals  (“JIXING”), a clinical-stage biopharmaceutical company committed to bringing innovative medicines to underserved patients with serious and life-threatening diseases,  announced today the acquisition of BIIB131 from Biogen, for global clinical development. BIIB131 is an investigational drug for acute ischemic stroke (AIS). Its proposed mechanism of action includes both thrombolytic and anti-inflammatory activities. By restoring critical blood flow following acute stroke, it may benefit more patients over current standard of care by extending the otherwise short treatment window. In the prior Phase 2 clinical trial conducted in Japan, patients treated with BIIB 131 had significantly improved clinical outcomes (proportion of patients with no or minimal neurological deficits) at 90 days, compared to placebo.  This was further supported by safety and angiographic findings. "Stroke is a serious threat to global health.  BIIB 131 represents a potential breakthrough for a critical condition (AIS) that has not seen any meaningful pharmacologic innovation for almost 30 years. We hope to prove that BIIB 131 will significantly improve clinical outcomes for AIS patients around the world”, said Sandy Mou, Board Executive Director and Chief Executive Officer of JIXING. “This acquisition will not only enrich JIXING’s pipeline, but also accelerate the execution of our globalization strategy.” “We believe that BIIB131 has the potential to change the way we treat acute strokes,” said Roderick Wong, MD, Managing Partner and Chief Investment Officer of RTW Investments, LP. “We would like to thank Biogen and TMS for their ongoing partnership and for their efforts to bring this asset to where it is today.” Under the terms of the agreement, JIXING will acquire the program for an undisclosed upfront with potential milestones and royalties on global sales. JIXING is a biopharmaceutical company headquartered in Shanghai committed to bringing innovative science and medicines to underserved patients with serious and life-threatening diseases in China and around the world. Backed by RTW Investments, LP, JIXING was founded in 2019 and partners with global biotechnology companies to develop and commercialize novel, innovative therapeutics to treat unmet medical needs in cardiovascular and ophthalmic diseases. With a strong and further developing asset pipeline, seasoned management team, and patient-centric focus, JIXING is dedicated to delivering a meaningful and lasting impact on patients. JIXING’s cardiovascular portfolio includes 3 assets in late-stage clinical development (aficamten, etripamil, omecamtiv mecarbil) and 1 in pre-clinical stage (JX09). JIXING's ophthalmology portfolio includes 4 assets in late-stage clinical development (varenicline solution nasal spray/US brand name TYRVAYA, OC-02 nasal spray, JX06/LNZ100, JX07/LNZ101) and 1 asset in pre-clinical stage (JX08). For further information about JIXING, please visit www.jixing.com . SOURCE: Ji Xing Pharmaceuticals