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2018.08.30

Lumosa partner submitted clinical trial application for LT1001 in China

Lumosa Therapeutics Co., Ltd. (6535. TWO) (“Lumosa”) today announced that its partner, Syntano Technology Venture (“Syntano”), a subsidiary of the Haike group, has submitted Clinical Trial Application (CTA) to the China National Drug Administration (CNDA) for Lumosa’s long-acting analgesic injection, LT1001 (the product name used in Taiwan: Naldebain®) as a Class 5.1 New Drug. Lumosa will receive milestone payment correspondingly. Clinical trials for Class 5.1 (Imported New Drugs) require fewer subjects for confirmatory purpose, which would shorten the registration process for LT1001 to be launched in China.


Haike Group was established in1988 and is the first Chinese petrochemical company listed in London Stock Exchange. Today’s Haike Group is a conglomerate of petrochemical, biopharmaceutical, international finance and trade companies. Syntano is the subsidiary of Haike Group dedicated to new drug development.

 
LT1001 is Lumosa’s first launched new drug. 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. The analgesic effect of Naldebain® is comparable to that of morphine but with much fewer side effects and better safety profile, offering high pharmacoeconomics.


In June of 2016, Lumosa granted Syntano exclusive right to develop and commercialize LT1001 in China, Hong Kong and Macau. Syntano is responsible for conducting all clinical trials to obtain the market approval, registration and marketing activities in these territories. Lumosa receives upfront, milestone payments and royalties.

 
According to the license agreement, Lumosa is entitled to milestone payments for CTA application to the CNDA, and the approval of the CTA, respectively. After the submission of CTA by Syntano, Lumosa will recognize an income of RMB 5 million. Due to parties’ mutual confidentiality agreement, other contents of the license agreement are not disclosed.


According to the classification system of CNDA, a Class 5.1 New Drug is an imported branded new drug. Comparing to Class 1 New Drugs, the clinical trial for a Class 5.1 New Drug normally involves fewer subjects, and faster to product launch.  Syntano will conduct the required clinical trials and proceed to New Drug Application (NDA) with relevant results and data, in order to obtain market approval in China.

 
In addition to the Chinese market, Lumosa has partnered with Amed Co., Ltd. (“Amed”) and launched LT1001 in Taiwan with continuing efforts in new indication exploration and market expansion. This year, Lumosa further expanded license agreement with Amed for the Southeast Asian market. In the field of long-acting analgesic injection for veterinary applications, Lumosa also signed an exclusive license agreement with Skyline Vet Pharma, a company based in the US, for the territories of North America, Australia and New Zealand. It is expected, continuous milestone incomes would be collected by Lumosa.

 
Dr. Wendy Huang, the CEO of Lumosa, indicates that “Through the rSD (reSearch and Develop) model, Lumosa is dedicated to new drug development and value-added innovations. LT1001 is the first successful case of its rSD model. Lumosa is committed to become a leading omnidirectional new drug development company.