On the 22nd, Handa Pharmaceuticals announced that its smoking cessation aid, HND-032, has received Final Approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA). The company is currently in discussions with its exclusive distributor, Company R, regarding the product’s market launch timeline. HND-032 is a generic version referencing Pfizer’s blockbuster drug Chantix/Champix. Although several generics are already available on the U.S. market, Handa’s lower production costs are expected to allow for profitable contributions once the product launches.
Buoyed by the approval news, Handa’s stock surged in early trading, rising as much as 9%, and maintained a gain of over 5% during the session.
HND-032 is a generic product referencing Pfizer’s widely used smoking cessation drug Chantix/Champix. In 2021, Chantix/Champix was found to contain excessive levels of nitrosamine impurities, a potentially carcinogenic substance, prompting Pfizer to recall and withdraw the product from the market. According to Pfizer’s annual reports, global sales of Chantix/Champix in 2020, 2021, and 2022 amounted to USD 919 million, USD 398 million, and USD 8 million, respectively. Currently, multiple generic manufacturers have secured FDA approvals and launched their versions in the U.S. market.
Handa further disclosed that on May 21, 2025 (U.S. time), it received formal notification from the U.S. Food and Drug Administration that its Varenicline Tablets, 0.5 mg and 1 mg (HND-032), had passed the ANDA review process and received Final Approval.
On December 31, 2020, Handa Pharmaceuticals, LLC, a subsidiary of Handa Pharmaceuticals, entered into an exclusive manufacturing and distribution agreement for HND-032 with Company P and Company R. Under this agreement, Company P will oversee commercial-scale production of HND-032, while Company R holds exclusive distribution rights for the U.S. market. Company R will pay Handa Pharmaceuticals, LLC a signing fee and share in the product's sales revenue.
Regarding the product’s launch in the U.S., Handa stated that it is currently in discussions with Company R to determine the optimal timing. Although there are over a dozen generic competitors already on the market and pricing is highly competitive, Handa believes that its lower production costs, along with the mutual support of its partners, will allow for modest yet profitable returns upon launch.
Resource: 漢達戒菸輔助劑FDA藥證申請獲准，上市時程與獨家經銷商討論中
