TSH Biopharm announced yesterday (4th) that its subsidiary Chuang Yi Biotech has received marketing approval from the TFDA for VA23, a generic version of the smoking cessation drug Varenicline. This marks the first Varenicline generic drug approved in Taiwan, which is expected to fill the long-standing supply gap in the local market caused by unstable supply from the original manufacturer.
VA23 was developed as a generic equivalent to Pfizer’s original Champix. Containing the active ingredient Varenicline, the drug is nicotine-free and helps reduce withdrawal discomfort and cigarette dependence. Produced through Chuang Yi Biotech’s international pharmaceutical partner, VA23 was approved by the U.S. FDA three years ago and has since been widely used in the U.S., with its efficacy validated in clinical practice worldwide. Now, as the first Varenicline generic drug in Taiwan, it is expected to bring a promising new option for smoking cessation treatments in the local market.
According to a 2024 survey by Taiwan’s Health Promotion Administration, the country’s smoking rate remains high. Among men, the smoking rate is 22.7% in the 50–64 age group, while for women it peaks at 7.2% in the 40–49 age group. Despite strict government regulations on e-cigarettes and heated tobacco products, the rate of experimentation among teenagers and young adults remains high, underscoring the persistent demand for smoking cessation medications. Clinical studies have also shown that Varenicline can significantly improve the success rate of quitting both cigarettes and e-cigarettes.
VA23 is manufactured at a facility certified by the U.S. FDA and the EU EMA under PIC/S GMP standards, ensuring compliance with international quality and safety requirements. TSH Biopharm stated that VA23 is expected to officially launch in the first quarter of 2026 as a prescription medication. The company plans to work with the Health Promotion Administration’s “Second-Generation Smoking Cessation Service Program” to include the drug in the government subsidy list, so that the public can access it without bearing the cost, thereby increasing willingness to quit smoking.
Chuang Yi Biotech has focused on public health and preventive medicine as its core development strategy. In addition to promoting smoking cessation drugs, the company has been the exclusive distributor of self-paid cell-based influenza vaccines to clinics across Taiwan for the past five years. TSH Biopharm noted that the introduction of VA23 not only addresses the shortage of smoking cessation drugs in the domestic market but also creates new business opportunities, which are expected to bring positive operational benefits and support the government’s policy goals to reduce smoking rates.
Resource: 東生華台灣首發戒菸藥學名藥領證，瞄準市場供應缺口，估明年Q1上市
