Pharmaceutical Companies Expand Overseas: Lotus Pharmaceutical Enters US Market, Taiwan Advanced Bio-Pharma Targets Japan

(CNA, reporter He Xiu-ling, Taipei, June 29) Pharmaceutical companies are reporting further progress in their overseas expansion. Lotus Pharmaceutical has secured approval from the U.S. Food and Drug Administration (FDA) for the first generic version of the influenza drug Xofluza, positioning it to enter the U.S. market. Meanwhile, Taiwan Advanced Bio-Pharma announced a licensing agreement with a Japanese pharmaceutical company for the biosimilar drug EG1206A for breast cancer in the Japanese market, expanding its Asian footprint.

Lotus Pharmaceutical announced today that its wholly-owned subsidiary, Alvogen Pharma US Inc., through its affiliate Norwich, has received U.S. FDA approval for the generic version of Baloxavir Marboxil tablets. The original drug is Xofluza, an influenza medication from Genentech, Inc., a member of the Roche Group.

Lotus Pharmaceutical stated that Baloxavir Marboxil tablets are the first generic version of Xofluza approved by the U.S. FDA. It is a single-dose oral antiviral medication indicated for the treatment of acute uncomplicated influenza in patients 5 years of age and older whose symptoms started no more than 48 hours prior. It is also indicated for the prevention of influenza in individuals 5 years of age and older following close contact with an infected person.

Another drug development company, Taiwan Advanced Bio-Pharma, announced today that following last year's exclusive global licensing and sales agreement with the international biosimilar giant Sandoz AG for its self-developed biosimilar EG1206A for HER2-positive breast cancer, covering markets beyond Taiwan, mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, and Japan, it has now signed a licensing and commercialization agreement with a Japanese pharmaceutical company for the EG1206A Japanese market.

Taiwan Advanced Bio-Pharma pointed out that this Japanese pharmaceutical company possesses extensive experience and technical capabilities in the pharmaceutical industry, is well-versed in Japanese pharmaceutical regulations, and has experience in the commercialization market. This is expected to facilitate the market application and sales strategy for EG1206A in Japan.

Taiwan Advanced Bio-Pharma stated that according to the agreement, this collaboration is projected to generate a potential commercial value of approximately NT$1.32 billion for Taiwan Advanced Bio-Pharma, including the signing fee, development and regulatory milestone payments, and post-launch sales royalties. The actual revenue recognized and its timing will depend on product development progress, regulatory review outcomes, launch timelines, market sales performance, and the terms of the contract. (Editor: Yang Lan-hsuan) 1150629

Stand with facts, your every contribution is a force to protect press freedom.

Download the CNA "One-Stop News" APP for real-time updates.

This website's text, images, and videos may not be reproduced, publicly broadcast, or publicly transmitted and used without authorization.