GWOXI is capitalizing on the dual opportunities of a super-aging society and regenerative medicine policies, with its new cell drug for stroke aiming for an early market launch.
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With Taiwan's two regenerative medicine laws passed this June, who will become the first domestic "dark horse" in cell therapy to obtain approval and enter the international market? As one of the earliest biotech companies in Taiwan to invest in stem cell regenerative medicine, GWOXI Stem Cell (6704) has been established for 20 years. It has not only secured a patent portfolio of over 100 patents in Taiwan, China, and the United States, but the development of its four stem cell new drugs has also successively entered the commercialization stage. Among these, its new stem cell drug "Si Yi You" for chronic stroke is expected to accelerate its domestic market launch through the conditional approval pathway. GWOXI Stem Cell Chairman Ming-Hsi Chuang stated that since moving into the Hsinchu Biomedical Science Park in 2011, GWOXI has continued to cultivate cell therapy development technologies. In its 5-story building in the park, the company has successfully and independently developed the "Medical-Grade Stem Cell Preparation Production Technology Platform" and the stem cell activation technology "Nigiro-Med®." These platform technologies are applied to address unmet medical needs. Based on its accumulated academic research in the new drug field and its close collaboration with medical institutions, GWOXI Stem Cell has currently developed four new stem cell therapy drugs. They target liver cirrhosis, chronic stroke, degenerative arthritis, and diabetes, which are all major diseases in Taiwan with increasing medical care needs.
GWOXI Secures Over 100 Patents and Develops New Cell Drugs; Stroke Candidate Takes the Lead, While Diabetes Program Goes Global.
Ming-Hsi Chuang emphasized: "GWOXI's position in the cell therapy value chain has always been clear: we view stem cells with a 'pharmaceutical' mindset. When conducting preclinical research, we don't simply look at a special process and apply it broadly. Instead, we develop products based on the pathological mechanism, with each indication having a corresponding special stem cell processing method."
Chuang added that because GWOXI places great emphasis on the process from R&D to clinical translation, it has already obtained over 100 patents in Taiwan, China, and the United States as part of its patent strategy.
The fastest-progressing of GWOXI's four new cell drugs are "Ruan Shi Li," for which a Phase III clinical trial application was submitted this September, and "Si Yi You." The latter, in collaboration with Hualien Tzu Chi Hospital President Lin Hsin-Jung, successfully completed its Phase II clinical trial report this September and is preparing to move to Phase III. "Si Yi You" is expected to become GWOXI's first independently developed cell therapy product to be launched. It is a cell therapy based on autologous adipose-derived stem cells, administered via intracranial injection. In its Phase II trial, 15 stroke patients who received "Si Yi You" treatment showed therapeutic effects within 2 weeks, with the high-dose group showing an average improvement of 1.2 points on the neurological function indicator NIHSS score in the second week. This improvement continued until the 24th week, reaching an average of 2.7 points, with 89% of patients showing an improvement in neurological function after treatment. Ming-Hsi Chuang pointed out that the indication for "Si Yi You" meets the standards for severe disability or life-threatening conditions under Taiwan's "two regenerative medicine laws." After regulatory bodies review its risk-benefit profile and confirm its safety and preliminary efficacy, it can be granted a temporary drug license with an effective period not exceeding five years through the conditional approval pathway, which will meet the growing domestic need for stroke treatments. Another important milestone is GWOXI's allogeneic stem cell therapy for diabetes, "Yi Dao Su." Chuang stated that in collaboration with Vietnam's VINMEC Medical Center, GWOXI completed the cell manufacturing process in Taiwan and transported the cell products via cold chain logistics to Vietnam to conduct a Phase I clinical trial. They have now successfully recruited 10 cases for treatment and are awaiting the clinical results after the follow-up period is complete.
Securing the upstream and downstream cell supply chain and striving for PIC/S GMP certification; also not missing out on the popular exosome market.
Ming-Hsi Chuang shared that GWOXI's new stem cell drugs for liver cirrhosis, chronic stroke, and degenerative arthritis have all had clinical literature published in journals such as Cell Transplantation and Journal of Tissue Engineering and Regenerative Medicine, and the company has also applied for invention patents. In addition to investing in new cell drug R&D, GWOXI has established a GTP cell processing center to provide clinical cell storage services, clinical cell preparation testing services, bio-resource cell bank sharing services, and more. With the goal of meeting international standards, the company is also transforming its second plant into a PIC/S GMP cell factory, which generates revenue through external services and provides support for the translation of GWOXI's new cell drugs.
Product Diversification and Technology Ming-Hsi Chuang stated that GWOXI has leveraged its foundation in cell therapy to develop a series of derivative products and technologies. For example, the company is engaged in exosome product development, as well as providing contract services for stem cell and exosome testing and manufacturing. The company is also collaborating on industry-academia projects with National Tsing Hua University and National Yang Ming Chiao Tung University, making an early strategic move in automated cell handling technology. Exosome Strategy With the exosome market booming in Taiwan, GWOXI has already applied for an INCI Name for its exosome products and a Drug Master File (DMF) with the U.S. FDA, ensuring it will not be absent from this field. The company is also currently in talks for several exosome-related contract manufacturing services. Future Goals Regarding future goals, Chuang said GWOXI's primary strategy is to prioritize obtaining domestic drug approvals. Its overseas development is planned to be through out-licensing or by seeking strategic partners to enter the international stage. Within the next 3 to 5 years, GWOXI's main goal is to strive for a new drug launch. It aims to get the product to market through conditional approval in the shortest possible time while simultaneously pushing for its production lines to pass formal GMP certification. This will allow for official manufacturing and facilitate subsequent Phase III clinical trials in a multi-country, multi-center model, which will further expand GWOXI's capabilities and capacity in cell therapy CDMO.