CAMBRIDGE, Mass. and BEIJING,  October 14, 2021,  Biogen Inc. (Nasdaq: BIIB) and InnoCare Pharma Limited (HKEX: 09969) announced today that the first patient has been dosed in the Phase 2 clinical trial of its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of multiple sclerosis (MS) in China. 


“There is a unmet medical need globally for additional effective treatment options for multiple sclerosis,” said Dr. Jasmine Cui, the Co-founder, Chairwoman, and Chief Executive Officer of InnoCare. “Given the potential efficacy and safety profile and promising blood-brain barrier (BBB) penetration, we believe that orelabrutinib has the potential to transform the treatment paradigm for this devastating disease.”


“The first patient dosed in the Phase 2 orelabrutinib study in China brings us closer to our goal of bringing a transformative treatment option to the MS community,” said Francis Wan, Head of Asia-Pacific and President of Biogen in China. “Biogen remains committed to expanding our presence in China and developing next-generation approaches that may improve outcomes for individuals living with progressive and relapsing forms of MS.”


Currently, the Phase 2 study of orelabrutinib for the treatment of MS is being conducted in the U.S., Europe and China, with patients already dosed in U.S. and Europe previously.


MS is an autoimmune, inflammatory disease of the central nervous system. The immune system destroys myelin surrounding nerves disrupting the normal functioning of the brain, optic nerves, and spinal cord through inflammation and tissue loss. It can cause muscle weakness, fatigue, and visual problems, and ultimately lead to disability.  It most often appears between the age of 20 to 40 years old and is the most common cause of non-traumatic neurological disability in young adults.


According to the Multiple Sclerosis International Federation (MSIF), more than 2.8 million people around the world are affected by MS today[1].


Orelabrutinib is a highly selective BTK inhibitor targeting both B-cell malignancy and autoimmune diseases. BTK, a key kinase in the B cell receptor signaling pathway, plays important roles in the development and function of B cells, macrophages, and microglia, which are involved in the immunopathological characteristics of MS. BTK inhibitors have the potential to transform the treatment paradigm of autoimmune diseases including MS.


In mid-July, InnoCare and Biogen entered into a license and collaboration agreement for orelabrutinib.


About Orelabrutinib
Orelabrutinib is a small molecule Bruton’s tyrosine kinase inhibitor (BTKi) developed for the treatment of cancer and in development for the potential treatment of autoimmune diseases.

In the field of multiple sclerosis, orelabrutinib is a BTKi with high selectivity and ability to cross the blood-brain barrier and could achieve high-target occupancy in the central nervous system. It is currently being investigated in a global Phase 2 study in RRMS patients.

In the field of oncology, InnoCare received approval for orelabrutinib from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (R/R SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (R/R MCL).


About Biogen

At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer’s disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.

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About InnoCare Pharma

InnoCare Pharma (HKEX:09969) is a commercial-stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with high unmet medical needs in China and worldwide. InnoCare was founded in 2015 by Dr. Jasmine Cui, who has extensive experience in new drug development and business management and the world-renowned structural biologist Dr. Yigong Shi. InnoCare has branches in Beijing, Nanjing, Guangzhou, Shanghai, New Jersey and Boston.

InnoCare has strong in-house innovation capabilities, holding multiple foreign and domestic patents with a rich product pipeline targeting liquid tumors, solid tumors, and autoimmune diseases. On March 23, 2020, InnoCare was successfully listed on Hong Kong Stock Exchange.

Biogen Safe Harbor

This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to the potential benefits, safety and efficacy of orelabrutinib; the timing and status of current and future regulatory filings; risks and uncertainties associated with drug development and commercialization, including orelabrutinib. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, uncertainty of success in the commercialization of orelabrutinib, which may be impacted by, among other things, the level of preparedness of healthcare providers to treat patients, difficulties in obtaining or changes in the availability of reimbursement for orelabrutinib and other unexpected difficulties or hurdles; the occurrence of adverse safety events; unexpected concerns that may arise from additional data or analysis; failure to protect and enforce data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges;; the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen’s business, results of operations and financial condition; product liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.



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[1] Source:MSIF website