NANJING, China, Jan. 26, 2023 /PRNewswire/ — As the tissue engineering and regenerative medicine industry has shown tremendous potential in clinical practices in recent years worldwide, China’s blue ocean market welcomes the first wave of acquisitions.
ReLive Biotechnologies, Ltd. ("ReLive" or "Company", a leading industry player, announces it has completed the acquisition of all operating assets of Germany-listed biotech company Co.Don AG (CNW.DF) ("Acquisition"), taking over the global patent rights of its flagship products "Spherox" and "Chondrosphere". "Spherox" is one of the only two authorized cell therapies for the regenerative treatment of articular cartilage defects globally. It was authorized by the European Medicines Agency (EMA) for distribution across Europe in 2017.
Simultaneously with the acquisition, ReLive also completed its Series A financing ("Series A") of $36 million to fund the Company’s global ambition. ReLive plans to use the fund for R&D, licensing, manufacturing, distributions, and other operational needs in China, U.S. and Europe.
Series A was led by Shanghai Healthcare Capital (SHC), with contributions from two existing angel investors, Indaco Capital and Jiuyo Capital, and a new joiner Watson Capital. G&G Capital serves as the financial advisor.
Aside from capital financing, SHC is also expected to support ReLive in both research innovation and commercialization with its robust industry resources. Backed by Shanghai Industrial Investment (Holdings) Co., Ltd (SIIC), Shanghai Pharma and other key players in the healthcare ecosystem, SHC is able to connect ReLive with research institutes, clinical institutions, industrial parks, and the whole medical supply chain.
"ReLive’s acquisition of Co.Don AG will underpin ReLive’s multiple R&D projects on the universal cell therapies for cartilage treatments. It also marks one of ReLive’s internationalization efforts, as the company aims at building a true global platform for regenerative medicine." said Dr. Xing Zhao, ReLive’s founder, Chairman and CEO.
He added that, ReLive will independently research and develop cost-effective tissue engineering products based on a combination of stem cell technology and 3D printing of scaffolds, targeting treatments of hyaline cartilage, osteochondral tissues, meniscus in orthopedics and sports medicine, and external ear reconstruction in plastic surgery.
Acquisition and Financing Fuel ReLive’s Growth Plan
ReLive is a leading company in tissue engineering and regenerative medicine with global aspirations. Founded by Dr. Zhao in 2021, the Company aims to fulfill the clinical unmet needs in the regenerative treatment market globally as it develops pioneering products in the areas of orthopedic sports medicine and reconstructive surgery. The Company will focus equally on independent R&D and acquiring authorized products and the world’s top-notch manufacturing and quality control facilities.
"Spherox" is one of the only two cell therapies for regenerative treatment of articular cartilage approved by western regulatory authorities. Authorized by the European Medicines Agency for distribution across Europe (including EU, U.K., Switzerland, etc.), the therapy has benefited over 17,000 patients with sufficient evidence of efficacy and safety.
By taking over 100% of Co.Don AG’s core assets via its subsidiary in Germany, ReLive acquires the global patent rights of Spherox, industry-leading manufacturing facilities that meet the "Good Manufacturing Practices"(GMP) standards in two locations in Germany, and quality control facilities and systems. With global patent rights and distribution rights in Europe, the acquisition marks a leap forward in ReLive’s global landscape.
"Co.Don AG owns the world’s top commercial ‘GMP’ production quality control system and the world-leading fully automated production lines. We believe the CMC system and the product line will underpin ReLive’s universal upgrade of cell therapies for cartilage treatments. ReLive will also introduce the CMC system to China and U.S. to support the Company’s global operations," Dr. Zhao said.
May Liang, Partner of SHC said, "the number of osteoarthritis patients has exceeded 400 million globally, and the incidence rate is over 50% for people older than 60 years old. Regenerative therapy is one of the most effective and vital ways to treat cartilage defects. SHC will continuously pay close attention to new innovations in the area."
"ReLive, through this acquisition, not only has the world’s most advanced regenerative technology but also grew with the best global blueprint. We look forward to supporting ReLive to become the leading global cell therapy platform." she added.
"Meanwhile, SHC is actively seeking advanced biotech targets overseas for its planned USD fund. SHC’s partnership with Hong Kong Science and Technology Parks Corporation (HKSTP) and Shanghai Pharmaceuticals Holding (SPH) will further help SHC to synergize the on-shore and off-shore assets to build a ‘global investment ecosystem’."
SHC’s investment in ReLive aligns with Shanghai’s ambition to establish an innovative biotech hub with international influence. In 2022, Shanghai released a three-year action plan to boost Shanghai’s cell therapy and accelerate industrial innovation between 2022 and 2024, aiming to increase the scale of cell therapy to 10 billion yuan by 2024. SHC will exploit "the matrix of governments, industry, academics, research, treatments and capital" to support the research and development of the world’s most advanced cell therapy, and benefit more patients.
More to Come
This Acquisition marks only the beginning of ReLive’s global expansion.
In the future, ReLive will exploit strengths of the U.S., Europe, and China. ReLive will locate R&D in Boston, the world’s most advanced biotech hub, continue the manufacturing and global distribution of the existing products in Germany, and focus on product listing and distribution in the US and China. Moreover, ReLive will actively seek strategic partnerships for technology transfers and licensing opportunities in ASEAN, South America, the Middle East, Mexico, and Japan to continuously expand the market globally.
In China, ReLive has completed the construction of a production facility for Spherox’s, and the Company plans to expeditiously carry out the required bridging clinical trials before launching China’s first approved cell therapy for cartilage repair.
In other markets like Singapore and HongKong, ReLive is able to take the expedited evaluation route in the pre-submission phase for Spherox as it was already approved by EMA, one of Health Sciences Authority’s (HSA) comparable overseas regulators. ReLive has submitted the application for listing to HSA. ReLive is also preparing for similar submission to the US FDA.
ReLive’s ambition is backed by a team of top scholars and industry practitioners.
The Company’s founder Dr. Zhao is a seasoned scientist who completed his Ph.D. and post-doc in Regenerative Medicine at the Utrecht University and Harvard Medical School. He served as the Director of Research & Development and Chair of Research Steering Committee at Vericel when its flagship product MACI received approval from the FDA in 2017.
The Company introduced the Strategy and Science Advisory Board that is composed of world-class academics, clinical experts, and top industry leaders, including professors of Orthopedics at Harvard and the Director of Sports Medicine at Mayo Clinic.
Besides the current therapies, a universal version of the cell therapy researched and developed by ReLive is now in the pipeline. The new features are more patient-friendly as the new generation does not require a second surgery. This upgrade will also make scale manufacturing possible.
ReLive will continue to cooperate with top scholars from Harvard and M.I.T, and top industry practitioners to expand the Company’s innovative pipelines and applications. It will focus on the cross-disciplinary collaboration of the most advanced cell and gene therapies and novel scaffold materials in the application in Orthopedics including treatments of articular hyaline cartilage, osteochondral and meniscus, and in the area of plastic and cosmetic surgery such as ear reconstructions.
The US$36 million fund as a vital addition will also stimulate the company’s global expansion.
Dr. Zhao said: "2022 has been very tough for fundraising given the unprecedented challenges posed to political and business environments. However, we managed to complete our Series A as well as the asset acquisition of Co.Don AG in 2022, laying the ground for our global landscape, and for our ambition to become a leading global regenerative biotech company."
"Special thanks for the trust and support from all our investors, especially SHC as the lead investor and a key supporter of the asset acquisition, for empowering ReLive with all-round tremendous resources. We believe ReLive will be a phenomenal success with our joint efforts," Dr. Zhao added.