Harbin Pharmaceutical Secures 20-Year Exclusive Rights to Six Teva Products in China with 160 Million RMB Investment

Yesterday (October 23), Harbin Pharmaceutical Group Holding Co., Ltd. announced that, in order to further enrich the company’s generic drug pipeline, optimize its product portfolio, and effectively enhance product competitiveness, its board of directors resolved to approve signing an “Authorization and Distribution Agreement” with Teva Pharmaceutical Industries Ltd. (hereinafter referred to as “Teva”) and to carry out related activities such as production technology transfer. The investment is estimated at RMB 160 million.

According to the announcement, the products involved in this transaction include six varieties registered by Teva in China: Clopidogrel Bisulfate Tablets (antithrombotic), Acitretin Capsules (for psoriasis treatment), Cyclosporine Soft Capsules (for prevention of immune rejection after organ transplantation), Lamotrigine Dispersible Tablets and Topiramate Tablets (for treating epilepsy in adults and children), and Flutamide Tablets (for prostate cancer treatment). Data shows that these are all major products with annual sales exceeding RMB 100 million. In 2017, their total domestic sales reached RMB 14.89 billion, with Clopidogrel Bisulfate Tablets alone achieving domestic sales of RMB 12 billion.

Meanwhile, among these six products, Clopidogrel Bisulfate Tablets rank as the second best-selling drug globally. Currently, it is the most significant product in China’s anticoagulant market segment, commanding the largest market share and attracting extensive industry attention. Only four domestic companies hold marketing authorization for this product, with its single-product market share exceeding RMB 12 billion. Acitretin Capsules are the originator product and have been designated as the reference listed drug in China’s consistency evaluation program. The remaining five generic products are eligible for direct exemption or expedited approval through the domestic generic drug consistency evaluation. By acquiring these clinically popular products through cooperation, Harbin Pharmaceutical Group Holding Co., Ltd. will inevitably exert a certain impact on the market shares currently held by these enterprises.

Meanwhile, according to the announcement, the transaction primarily includes: exclusive sales agency rights for six products in Mainland China (excluding Hong Kong, Macau, and Taiwan) for a term of 20 years, with automatic renewal unless the agreement is terminated for cause; relevant technical documentation for the six products; the exclusive right to use the Teva trademark to develop designated products in Mainland China (excluding Hong Kong, Macau, and Taiwan) during the agreement period; and Teva’s assistance in obtaining domestic marketing approval for the six products in China.

SFDA Southern CenterPharmaceuticalsLin Jianning, Director of the Institute of Economics, stated that through this collaboration with Teva, Harbin Pharmaceutical Group Holding Co., Ltd. can leverage the multinational corporation’s R&D and manufacturing capabilities. This will not only enhance its production technology and product quality but also further optimize its product portfolio, enrich its pipeline of high-end clinical generic drugs, and strengthen its sustainable operational development and core competitiveness. At this critical juncture when domestic pharmaceutical companies are accelerating their consistency evaluations, this move serves as an expedited pathway for Chinese firms to achieve compliance. Meanwhile, Teva’s high-end clinical products can expand into the Chinese market by leveraging Harbin Pharmaceutical’s marketing channel advantages, potentially exploring a new route for international pharmaceutical companies to access the domestic market. Therefore, the international cooperation between Harbin Pharmaceutical and Teva holds significant strategic importance for Harbin Pharmaceutical and offers valuable insights for Chinese pharmaceutical companies currently undergoing the critical phase of consistency evaluations.

Some viewpoints also point out that the signing of the cooperation agreement with Teva is actually one step in Harbin Pharmaceutical Group Holding Co., Ltd.'s transformation.

In its previously released semi-annual report, Harbin Pharmaceutical Group Holding Co., Ltd. indicated that its product portfolio primarily focused on anti-infectives, cold remedies, cardiovascular and cerebrovascular agents, digestive system drugs, antineoplastic agents, and nutritional supplements. The products acquired in this transaction include clopidogrel bisulfate tablets for antithrombotic therapy, flutamide tablets indicated for prostate cancer, acitretin capsules for the treatment of psoriasis, and lamotrigine dispersible tablets for epilepsy. Compared with its existing portfolio, this acquisition not only consolidates Harbin Pharmaceutical’s current product foundation but also expands its original product line.

Relevant media outlets have commented: Harbin Pharmaceutical Group Holding Co., Ltd. started early in the health supplement business and achieved considerable success; however, its product updates and iterations were relatively slow. Since peaking in 2012, the company has been on a downward and fluctuating trajectory. The current introduction of products with strong market prospects as “therapeutic necessities” may well be an essential step for Harbin Pharmaceutical’s successful transformation.