Handa Pharmaceuticals has made remarkable strides in the U.S. pharmaceutical market with the launch of two significant drugs, HND-002 for gastroesophageal reflux and HND-020 for multiple sclerosis. These introductions have led to an extraordinary annual revenue increase of 1727%, reaching 981 million Yuan in just the first 11 months of this year.
Chen Junliang, the general manager of Handa, forecasts a bright future, anticipating the release of a new drug each year with a visibility exceeding three years. Notably, in the upcoming year, the profits from the company’s 505(b)(2) drugs are expected to surpass those from generic drugs, marking a significant shift in Handa’s revenue model.
The U.S. FDA categorizes drugs into three types: new ingredient new drugs, 505(b)(2) new drugs, and generic drugs. Handa’s focus lies in the 505(b)(2) category, which includes new dosage forms or compounds based on previously approved ingredients. This strategic approach has allowed the company to secure profits without involving itself in manufacturing or sales directly.
Two of Handa’s drugs, notably for gastroesophageal reflux and multiple sclerosis, have been pivotal in turning the company profitable this year. Looking ahead, Handa is setting its sights on two promising drugs: HND-033, an anti-cancer drug with a global market size of about US$2.1 billion, and HND-032, a smoking cessation drug currently under FDA review.
The success story of Handa is also attributed to their adaptation of existing drugs into more user-friendly forms, like transforming Novartis Pharmaceuticals’ Gilenya Capsules into orally dissolving formats for easier consumption. This innovation, coupled with patient support care plans and long-term medication tracking, positions Handa for continued revenue growth in the coming year.
