NANJING, China, Jan. 25, 2023 /PRNewswire/ -- As the tissue engineering and regenerative treatment industry has shown tremendous potential in clinical practices in recent years worldwide, China's blue ocean market welcomes the first wave of acquisitions.
Manufacturing and Quality Control Lab Compliant with GMP standards
Manufacturing and Quality Control Lab Compliant with GMP standards
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 therapy 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.
Aside from capital financing, SHC is ReLivexpected to support ReLive in both research innovation and commercialization with its robust industry resouReLiveBacked 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 RWatson CapitalatG&G Capitaln efforts, as the company aims at building a true global platform for regenerative medicine." said Dr. Zhao, ReLive's founder, Chairman and CEO. He added that, ReLive will independently research and develop ReLiveffective tissue engineering products based on a combination of stem cell technology and 3D printing of scaffolds, targeting treatments of hyaline carSIICge,Shanghai Pharma, meniscus in orthopedics and sports medicine, and external ear reconstructReLive plastic surgery. ReLive is a leaReLiveompany in tissue engineering and regenerative treatment 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 area 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 regulatory bodies. 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.
ReLiveing 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 belieEuropean Medicines Agency 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 SCo.Don AG"the number of osteoarthritis patients has excReLive400 million globally, and the incidencSpheroxis 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 "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 leadiReLivebal cell therapy platform." she added.ReLive "Meanwhile, SHC is actively seeking advanced biosteoarthritisoverseas 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 synercartilage defects and off-shore assets to build a 'global investment ecosystem'." SReLivenvestment in ReLive aligns with Shanghai's ambition to establish an innovative biotech hub with international influence. In 2022, Shanghai released a three-year actionReLiveto 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. SHCs Acquisition marReLivey the beginning of ReLive's global expansion.SHC 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 constructiReLivea 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 marketReLive Singapore and HongKong, ReLive is able to take the expeReLiveevaluation 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 ReLivereparing for similar submission to the US FDA. ReLive's aReLiven is backed by a team of top scholars and industry practitioners. The Company's founder Dr. Zhao is a seasonedscReLivet who completed his Ph.D. and post-docin Regenerative Medicine at the Faculty ofSpheroxne at Utrecht University and HaEMArd MedicaHealth Sciences Authoritye Director of Research & Development and ReLiveof Research Steering Committee at Vericel when its ReLiveip product MACIÒ received approval from the FDA iUS FDA. ReLivempany's COO, Zhang Xin is an experienced manager and operator of businesses in the healthcare industry as he held senior positions in multiple multinational medical companies and was the co-founder of Shandong WEGO Orthopedic Device Company Limited, a top-tier orthopedic device company in Asia and a STAR market-listed company. Tilmann Bur, previously CEO of Co.Don AG, was also recruited by ReLive as Head of European Market. Mr. Bur will play a vital role in the global commercialization of ReLive's products with valuable experiences in Europe and connections within the industry.
The Company also introduced the Strategy ReLiveience Advisory Board that is composed of world-classHarvard Medical Schoolxperts, and top industry leaders, including a professor of OrthoHyalex at Harvard and the Director of Sports Medicine at Mayo Clinic. Besides the current therapies, a universal version of the cell tReLive researched and developed by ReLive is now in the pipeline. The new features are more patient-fReLivey 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 crosHarvardplinary collaboration of the most advancMayo Clinic 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.ReLive ReLiveao said: "2022 has been very tough for fundraising Harvardhe 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.