Sze Yuan Yang, General Manager of TSH Biopharm (8432-TW), served as a speaker for the "Taiwan Biomedical Industry Licensing, Market Access, Joint Venture, and M&A Opportunities" seminar today (31). Organized by PwC Taiwan and co-organized by the Taiwan Pharmaceutical Industry Association, the seminar responded to the government's new policy direction, focusing on topics such as cross-border industry licensing cases, biomedical industry licensing methods, considerations for contracts, and CDMO. General Manager Sze Yuan Yang shared how TSH Biopharm has accelerated the integration of comprehensive clinical treatments through authorized access in a short period, submitting 16 Asian applications and successfully handling 2 patent linkage cases.

Firstly, General Manager Sze Yuan Yang pointed out that in the field of pharmaceutical biomedicine, the transaction amount of licensing has always been a hot topic. However, the so-called authorized access is actually a series of processes that allow drugs to go from pre-clinical, clinical trials, inspection registration to licensing and listing. If a piece of the puzzle is missing, the entire case may fail or be delayed in listing compared to competitors, which will significantly affect valuation and investment recovery. Therefore, in the entire process, the question of which partners to cooperate with or which strategies to use to accelerate product listing to support clinically unmet treatments is a very important issue.

In recent years, General Manager Sze Yuan Yang found that due to the decrease in the number of new small molecule drugs, large pharmaceutical companies have begun to enter what is called "technology platform" strategic alliances, focusing on jointly developing and jointly selling strategies, unlike the old cooperation models. The diseases ranked in the top five in terms of transaction amount under this model are cancer, central nervous system diseases, autoimmune diseases, ophthalmology, and cardiology.

Although the number of transactions has slightly decreased in recent years under the impact of the COVID-19 pandemic, the transaction amount has remained stable. This indicates that companies with funds and flexible strategies still have a great opportunity to acquire desired items. In addition, General Manager Sze Yuan Yang judged that the key lies in how to make the entire transaction process fast and optimized, which can provide an advantage for products to be quickly listed. There are several steps involved: obtaining cases, signing confidentiality agreements, setting up business frameworks, valuation appraisals, and contract signing. However, due to the increasing number of early-stage research and development cases, estimating a suitable value that both parties can agree on is a major challenge. Intellectual property and legal professionals play a significant role in this because it is highly relevant to overall valuation and whether patents can actually be obtained and implemented. Success or failure depends on the expertise of both parties at each stage, and both strategic and executive capabilities are significant tests.

General Manager Sze Yuan Yang cited the results of the "Dual-Engine Strategy" executed by TSH Biopharm over the past three and a half years as an example: This strategy, implemented through alliances, rapidly brings products to market. Utilizing over 20 years of practical experience, within three years, they partnered with 32 global collaborators, including 14 international pharmaceutical companies, 8 CDOM contract development and manufacturing service companies, 6 CRO contract research organizations, and 6 NGS precision medical laboratories, spread across Asia, Europe, the United States, South Korea, Taiwan, and Southeast Asia. This enabled TSH Biopharm to successfully submit 16 Asian applications in an extremely short time and successfully handle 2 patent linkage cases. Currently, 3 cases have obtained Taiwanese drug certificates, one case has received National Health Insurance coverage and will be effective for clinical use tomorrow (November 1st). By effectively utilizing authorized access to accelerate the integration of comprehensive clinical treatments, TSH Biopharm is the best example of success.

Finally, General Manager Sze Yuan Yang reminded that the valuation of all licensing cases needs time to be verified. Therefore, choices regarding the treatment field, the value of key technology platforms, supply price competitiveness, etc., all affect whether the transaction can proceed to the final crucial stage. Signing a contract is just the beginning; how to integrate both parties and quickly achieve milestones to complete clinical trials and obtain market approval is the true practice of expertise!