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Simcere and Avilex Pharma Announce Strategic Regional Licensing Partnership to Develop and Commercialize AVLX-144 for the Treatment of Acute Ischemic Stroke (AIS) in Greater China

Release time:2021-12-17

Nanjing, China, and Copenhagen, Denmark, December 17 2021 – Simcere Pharmaceutical Group Ltd (HKEX: 2096) (Simcere) and Avilex Pharma (Avilex), a clinical-stage biotechnology company focused on developing innovative medicines for neurological disorders, and today announced that they have entered into a strategic regional licensing partnership to develop and commercialize medicines that target the postsynaptic density protein 95 (PSD-95) to treat acute ischemic stroke (AIS) and other neurological conditions in Greater China.

The agreement grants Simcere an exclusive regional license to develop and commercialize AVLX-144, Avilex’s 2-ready dimeric PSD-95 inhibitor, for the treatment of AIS and other neurological conditions, as well as access to the company’s library of early peptide candidates.

AVLX-144 is a dimeric peptide-like drug candidate for the treatment of AIS, which targets the intracellular scaffolding protein, PSD-95. AVLX-144 is an extensively optimized dimeric PSD-95 inhibitor and a clinical lead candidate for the treatment of acute conditions such as AIS and subarachnoid hemorrhage (SAH). PSD-95 bridges the glutamate receptor subtype - the N-methyl-D-aspartate (NMDA) receptor and neuronal nitric oxide synthase (nNOS) via its two PDZ domains and AVLX-144 binds to both these PDZ domains simultaneously. The specific design of AVLX-144 provides several key advantages such as exceptionally high affinity to PSD-95, increased stability, and enhanced neuroprotective properties. 

Under the terms of the agreement, Avilex will receive an undisclosed upfront payment and will also be eligible for payments upon achievement of certain development and sales milestones, with all components amounting to a total of over USD175 million. In addition, Avilex will receive royalties on sales. Further financial details were not disclosed.

“We are thrilled to be entering into this agreement with Simcere. From the very start of discussions, it was clear that the companies shared a common belief in the scientific rationale of our programs; recognized the obvious synergistic fit with Simcere’s portfolio; and most importantly built a solid collaborative culture that will be critical in ensuring successful execution of the development plans moving forward. We have full trust and confidence in the Simcere team and are hopeful to soon be able to provide an effective therapy to patients in need.” says Kristian Strømgaard, professor, PhD, and CEO of Avilex Pharma.

“We are extremely pleased to have entered into this agreement with Avilex to leverage the potential of innovative PSD95-targeting agents to treat stroke in Greater China,” added Kevin Oliver, PhD, Senior Vice President and Head of Global Business Development at Simcere. “Both partners are clearly committed to delivering meaningful therapies to stroke patients in need, in line with Simcere’s mission of providing today’s patients with medicines of the future.”

About Avilex Pharma

Avilex Pharma is a Denmark-based clinical stage biotech company developing a proprietary and novel class of neuroprotectants to treat patients suffering from acute conditions such as acute ischemic stroke and subarachnoid hemorrhage. The company was born out of research from the University of Copenhagen, established by Novo Holdings A/S, and supported by funding from the Wellcome Trust, the Danish Innovation Fund, and the Danish Growth Fund. For more information, please visit www.avilexpharma.com 

About Simcere

Simcere Pharmaceutical Group Limited is rapidly transitioning to an innovation and R&D-driven pharmaceutical company, with a mission of “providing today’s patients with medicines of the future.” It has established a national key laboratory of translational medicine and innovative pharmaceuticals. Simcere has a diversified product portfolio in strategically focused therapeutic areas, including oncology, central nervous system diseases and autoimmune diseases, with leading positions in their respective therapeutic segments and/or established track record. Its vigorous in-house R&D efforts and extensive R&D collaborations have made it a strategic cooperation partner with world leading pharmaceutical companies and biotechnology companies, in an effort to bring more global life science breakthroughs to China. For more information, please visit www.simcere.com.

Forward Looking Statements

Information set forth in this press release contains forward-looking statements, which involve a number of known and unknown risks, uncertainties and assumptions. The forward-looking statements contained herein reflect the current judgment and views of Simcere Pharmaceutical Group Limited as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, or may not materialize, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements, whether as a result of new information, future events or otherwise, to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

For more information, please contact:

Avilex Pharma

Media Contact

Dr. Kristian Strømgaard, CEO

Tel: (+45) 5123 6114

Email: kristian.stromgaard@avilexpharma.com 

Simcere Pharmaceutical Group Limited

Investor Contact

Dr. Jason Bao, Board Secretary and Executive Director

Tel: +86(25)8556 6366

Email: ir@simcere.com 

Media Contact

Jian Hou

Tel: +86(25)8556 6666

Email: simcere.mediarelations@simcere.com