YFY Biotech Management Company

 

Lumosa conducted a series of preclinical, clinical and pharmaceutical development works after licensing in LT1001, dinalbuphine sebacate, from the Ministry of Science and Technology. After a successful phase 3 clinical trial in patients underwent post-hemorrhoidectomy in August 2015, an NDA application submitted to TFDA in September of the same year.  With TFDA's approval of LT1001, Lumosa has written a new page in Taiwan's history on new drug development.

 

Rights to sales and marketing of Naldebain® in Taiwan were licensed to InteRx Biomedical Co., Ltd., a subsidiary of AMED Group, in December 2015. In addition, sales and marketing rights to mainland China, Hong Kong, and Macau, were licensed in June 2016 to Syntano Technology Venture, a Haike company (Syntano). Following TFDA's approval of LT1001, development milestone payments as well as royalties from sales are expected from the above mentioned signed agreements.

 

LT1001 is best known for its safety and long-acting features. It is the only analgesic injection drug to offer a 7-day pain-relieving effect that is indicated for the relief of moderate/severe post-surgical pain. Trial results indicated that the analgesic effect of LT1001 is comparable to that of morphine but with much fewer side effects and better safety profile, offering higher pharmacoeconomics that may facilitate patients' post-surgical recovery. In the meantime, reduce the use of concomitant medication, lower the burden and risks of healthcare professionals, and improve patients' quality of life. LT1001 offers a better choice in pain management to satisfy the need for pain relief for many patients.

 

To maximize the market value of LT1001 and increase investment returns, Lumosa has initiated product lifecycle management program including the development of new formulation and new indications are under progress. Likewise, Lumosa has committed to assisting InteRx in developing new indications to increase market size of LT1001. Further, veterinary formulations are being exploited to expand into companion animal market.

 

Pain management is one of the important practices in medical care. According to literature, 20% of the population in the world suffers from pain, with 40%~50% surgical patients not receiving adequate post-operative pain control. Nevertheless, most analgesic available globally are short-acting, besides adding costs and burdens to healthcare professionals, patients also have to endure constant pain and repeated treatment processes. The lack of long-acting and safe pain management caused poorly controlled pain for an extended period time which negatively impacted the patients' quality of life and most likely would hinder the healing processes.

 

Dr. Changhai Tsai, Chairman of Lumosa stated: "LT1001 was originally invented by scientists in Taiwan, then the technology got transferred to Lumosa where a series of value enhancement works were conducted through Lumosa's rSD platform before LT1001 was later licensed to a marketing partner in Taiwan. Now that the drug is approved by the Taiwan regulatory authority, patients will benefit from the success of this collaboration involving the pharmaceutical industry, government, and academic research organizations. LT1001 is not only the first drug from Lumosa to be approved, but is also a novel drug entirely developed domestically in Taiwan, making this an important milestone in Taiwanese biotech industry."

 

Dr. Wendy Huang, CEO of Lumosa said: "TFDA and CDE demonstrated high level of efficiency throughout the review and approval process. I am pleased to see that LT1001 received its first approval and Taiwan will be the first market for the product launch. The launch of LT1001 in Taiwan is only the beginning of success we envision for Naldelban as licensing activities to other regions are actively progressing. Lumosa will continue developing new formulation and new indications to expand LT1001's market. More importantly, royalties from the sales of LT1001 will greatly fund Lumosa's R&D pipeline and the next generation of great products under our rSD operation model, and establish a sustainable pipeline. All these are to make Lumosa the top new drug development company in Asia."