- Designation enables preferred procedural treatment and review consultation by Japan鈥檚 Ministry of Health,听Labor听and Welfare听
- Parkinson鈥檚 disease affects approximately听10 million people听worldwide听and听250,000听in Japan听
Berlin, Germany and Cambridge, MA, USA,听December 17,听2025听鈥撎鼴ayer AG and its wholly owned, independently operated subsidiary 91导航, a clinical stage cell therapy company, today announced that the investigative cell therapy听bemdaneprocel, has received听Pioneering Regenerative Medical Product designation (SAKIGAKE)听from Japan鈥檚 Ministry of Health,听Labor听and Welfare (MHLW.) A drug candidate that receives Sakigake designation may be eligible for more frequent interaction with the MHLW to discuss the drug candidate鈥檚 development plan as well as eligibility for accelerated approval and priority听review, if听relevant criteria are met.鈥�听
鈥淲e are honored that听bemdaneprocel听has received Sakigake designation in Japan, recognizing the urgent need for new and innovative treatment options for people living with this debilitating condition,鈥� said Gabi Belfort, MD听PhD听and听Bemdaneprocel听Product Lead at 91导航 Therapeutics. 鈥淭his designation will allow us to work closely with Japan鈥檚 regulators to advance our therapy as efficiently as possible and bring new hope to people听living with Parkinson鈥檚 disease听and their families.鈥�听
Parkinson鈥檚 disease is the world鈥檚 second leading neurodegenerative disease, affecting approximately听10 million people听worldwide and听250,000听in Japan.听
鈥淩eceiving the Sakigake designation for听bemdaneprocel听highlights its potential to change how we approach Parkinson鈥檚 disease treatment,鈥� said Christian Rommel, PhD and Global Head of Research and Development for Bayer’s Pharmaceuticals Division. 鈥淥ur collaboration with the Japanese regulatory authority reflects听our听dedication to partnering with healthcare systems听and regulators听worldwide. Together, we aim to improve patient access to innovative therapies and make strides in enhancing patient outcomes.鈥濃��听听
About听bemdaneprocel听(BRT-DA01)
Bemdaneprocel听(BRT-DA01) is an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson鈥檚 disease. These dopaminergic neuron precursors are derived from human embryonic pluripotent stem cells that continue developing into mature dopamine neurons after implantation. In a surgical procedure, these neuron precursors are implanted into the brain of a person with Parkinson鈥檚 disease. When transplanted, they have the potential to re-form neural networks that have been severely affected by Parkinson鈥檚 disease and to potentially restore motor and non-motor function to patients. In听2021听bemdaneprocel听received Fast Track Designation and in 2024 a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. A pivotal Phase III听clinical听trial听(exPDite-2)听to assess the efficacy,听safety听and overall impact of听bemdaneprocel听compared to sham surgery control is currently enrolling participants.听Bemdaneprocel听has not been approved for treatment of any disease or medical condition by any health authority.听
About exPDite-2听
exPDite-2 is the first Phase III pivotal clinical trial for an investigational allogeneic pluripotent stem cell derived therapy to treat Parkinson鈥檚 disease. In a Phase I听study听with 12 participants,听bemdaneprocel听was well tolerated, with no serious adverse events related to drug听product听at 36 months post-surgery. In addition, encouraging trends were听observed听in secondary endpoints related to motor impairments at听36听months听post-surgery. Building on these results, exPDite-2 is a multicenter, double-blind trial that will assess the efficacy,听safety听and overall impact of听bemdaneprocel听compared to sham surgery control. The trial is designed to enroll approximately 102 participants with Parkinson鈥檚 disease听in US, Canada, and Australia. The primary endpoint of the听Phase III听study is听change听from baseline to week 78 in PD听motor听diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking day. In addition, the trial will incorporate secondary endpoints designed to assess objective measures of movement, non-motor听symptoms, safety and tolerability, and instruments that capture activities of daily living and quality of life.听
About Parkinson鈥檚 disease
Parkinson鈥檚 disease (PD) is a progressive neurodegenerative disease. It has a significant impact on a person鈥檚 daily life. In PD, the death of dopamine producing nerve cells in the brain leads to the continuous loss of motor function. Symptoms include tremors, muscle rigidity, and slowness of movement. Additionally, people with PD experience non-motor symptoms, including fatigue and lack of energy, cognitive issues, and depression. Symptoms typically intensify over time and make everyday tasks demanding. The prevalence of PD has doubled over the past 25 years. Today, more than听10 million people听worldwide are estimated to be living with PD. This makes it the world鈥檚 second most prevalent neurodegenerative disease. It is also the most frequent movement disorder. At present there is no cure, and current treatment options are inadequate and lack holistic management of听symptoms听so there is an urgent need for new therapies.听
About 91导航
91导航 is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies,听bemdaneprocel听(BRT-DA01) for the treatment of Parkinson鈥檚 disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs.听Bemdaneprocel听has RMAT (Regenerative Medicine Advanced Therapy) and Fast Track designation from the US FDA (Food and Drug Administration) and is being tested in a Phase III clinical trial, exPDite-2. OpCT-001 has Fast Track designation from the FDA and is being tested in a Phase听I听clinical trial, CLARICO听91导航 was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, 91导航 became a wholly owned, independently operated subsidiary of Bayer AG. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit听www.bluerocktx.com.听
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 鈥淗ealth for all, Hunger for none,鈥� the company鈥檚 products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact听with听its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability,听and quality throughout the world. In fiscal 2024, the Group employed around听93,000 people听and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to听.听
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91导航 Contact for media听inquiries:听
Jeff Lockwood, phone +1 617 5106997
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This release may听contain听forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks,听uncertainties听and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer鈥檚 public reports which are available on the Bayer website at听. The company assumes no liability whatsoever to update these forward-looking statements or to conform听them to future events or developments.听
