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Regenerative Medicine

Currently, regenerative medicine has been in the spotlight for a number of years on the global stage. In particular, due to their ability to self-regenerate, differentiate into several cell lineages and participate in immunomodulation, mesenchymal stem cells (MSCs) are being investigated as promising treatment strategies. In recent news, Regeneus Ltd signed a license agreement with Kyocera Corporation for the development and commercialization of the former’s lead MSC and Secretome technology Progenza for Knee Osteoarthritis in Japan. The treatment met all safety and efficacy endpoints in its Phase 1 clinical study.

In other news, Cynata Therapeutics announced positive results pertaining to CYP-001, Cynata’s lead induced pluripotent stem cell (iPSC)-derived Cymerus™ mesenchymal stem cell (MSC) product. The safety and efficacy results were from the two-year follow-up of patients enrolled in the Phase 1 clinical trial for the treatment of steroid-resistant acute graft-versus-host disease (GvHD).

Similarly, emphasis has been placed by the Taiwan government on efforts to transform Taiwan into a regenerative medicine hub in Asia and to establish a robust regulatory and R& D environment for such procedures.

While the realm of regenerative medicine in Taiwan is still in its nascent stage, there is significant scope for growth, with about 20 companies in Taiwan in various stages of clinical development working on different areas of ATMPs such as autologous DCs, ADSCs, SMSCs, DPC, DF, NK, allogenic DF, SMSC, ADSC, BMSCs CAR-T, Neo-T, and auto-activated T cell therapies for various cancers, osteoarthritis, stroke, kidney diseases and more. In 2019, six cell therapies were approved by the government to treat medical issues, including cancer, degenerative joint disease, and skin wounds, which are expected to be available at permitted medical centers.

Earlier this year, UnicoCell Biomedical completed patient enrollment and analyzed a 24-week follow-up in its phase-I/IIa clinical trials of ELIXCYTE. ELIXCYTE is an allogeneic adipose stem cell product and is currently undergoing two human clinical trials as a treatment for osteoarthritis and chronic kidney disease. A case study of the development of mesenchymal stem cell-based pharmaceuticals, the company’s strategies and progress will be covered by Chia Che Tsai (Head of R&D at UnicoCell Biomedical) at the Stem Cell & Regenerative Medicine Taiwan conference this week.

Accompanying Dr. Chia are Taiwan’s top regenerative medicine professionals who are convening at the Stem Cell & Regenerative Medicine Taiwan conference (2-3 September, Virtual) to tackle challenges and brainstorm strategies. Some of the challenges faced are the higher cost of R&D for the development of regenerative medicine products, clinical trial approvals, and other regulatory hindrances. This conference recognizes that regenerative medicine is the future of the biopharmaceutical industry and is welcoming a community of cell therapy experts to engage in discussions on future plans and possible partnerships. 

Biotechnology Clusters

Over the years, Taiwan has been boosting its efforts in the biologics sector and is focusing on capturing a significant share of the global market. The government launched the “Taiwan Biotechnology Takeoff Diamond Action Plan” in 2009 with the following goals:

  1. Strengthening the country’s translational research and commercialization skills
  2. Establishing a biotechnology venture capital fund
  3. Founding a Food and Drug Administration
  4. Creating an integrated biotech incubation center

In line with its goals, it aimed to consolidate the R&D capabilities of government, academic, and research institutes by establishing biotech industry clusters. The country has 164 universities with more than 80 incubation centers within the campuses; 18 medical centers; a growing number of science-based industrial parks; and government and private nonprofit research institutes such as Academia Sinica, the Development Center for Biotechnology (DCB), the Industrial Technology Research
Institute (ITRI), and the National Health Research Institute (NHRI).

Two biotechnology clusters have already been built in Taiwan, with the Southern Taiwan Science Park hosting nearly 20 biopharmaceutical companies, and the Hsinchu Biomedical Science Park expected to accommodate 30 biopharmaceutical manufacturers. The government also plans to create an integrated incubation center, to be developed in a third park and called the National Biotechnology Development Park, which will also contain animal testing, R&D service, and legal information centers.

Bringing proof of Taiwan’s highly commendable efforts to consolidate and boost its biopharmaceutical R&D capabilities is the Biologics World Taiwan conference. In this session, case studies on ADC drug development efforts, biosimilars in development, regenerative medicine clinical trial results, single use systems, platform technologies and best practices in manufacturing and quality will be shared in testament of how far Taiwan has come in the past decade since the government announced their plans.

The conference is the country’s first and only platform for senior decision-makers who will influence the future of Taiwan’s biologics industry. On 2nd and 3rd September 2020, Taiwanese and international biopharmas, biotechs, CMOs, CROs, and solution providers will convene to discuss strategic issues, leverage partnerships, share best practices, and capitalize on the potential of Taiwan’s growing biopharmaceutical industry.

kashmiira nayar imapac marketing manager

Kashmiira is IMAPAC’s Marketing Manager – Branding & Content Strategy, responsible for driving demand generation, content marketing and brand development strategies. She is also actively involved in the company’s digital transformation efforts with the launch of its webcast and virtual conferences, digital ads and market reports.

Prior to her role in marketing, she was instrumental to the project management and production of IMAPAC’s life science conferences. Follow her on LinkedIn.