Guangdong Tainkang Pharmaceutical recently announced that its core product "Aitingjiu" Dapoxetine Hydrochloride Tablets have successfully obtained registration approval from Indonesia's National Agency for Drug and Food Control (BPOM). This achievement not only marks a breakthrough in the company's overseas product registration but also makes the drug the first generic version of its kind in Indonesia, signaling the official start of the company's commercialization process in the Southeast Asian market. The drug is a first-line treatment recommended by domestic and international guidelines for premature ejaculation, offering good clinical benefits, low safety risks, and rapid onset. It was independently developed by the company and launched in the domestic market in August 2020. Currently, the product holds a leading position in the domestic off-channel market for Dapoxetine Hydrochloride, particularly with a strong brand advantage in offline retail, laying a solid foundation for its overseas expansion.
To advance its market presence in Indonesia, Tainkang had previously reached a cooperation agreement and signed a distribution agreement with PT ANVITA PHARMA INDONESIA ("ANVITA"), a leading Indonesian biopharmaceutical company. ANVITA specializes in high-end small molecule API R&D and production as well as CDMO services, with a GMP-certified production base in Indonesia and over ten commercialized products. This partnership will provide strong support for the market promotion of "Aitingjiu" in Indonesia. Indonesia, as the world's fourth most populous country with over 270 million people, is one of the largest and fastest-growing pharmaceutical markets in Southeast Asia. Benefiting from universal healthcare programs, significant unmet clinical needs, and favorable policies, Indonesia's pharmaceutical market reached $11 billion in 2023, with a compound annual growth rate of 10%, and is expected to exceed $15 billion by 2025.
Additionally, Indonesia was China's largest pharmaceutical trade partner in ASEAN in 2024, with bilateral pharmaceutical trade growing at a compound annual rate of 12% over the past five years. The entry of "Aitingjiu" as a first generic is expected to leverage first-mover advantages to capture market share. Besides "Aitingjiu," Tainkang has also signed distribution agreements with ANVITA for "Aitinglie" Finasteride and Tadalafil Capsules, "Aitingwei" Tadalafil Tablets, and "Aitingda" Sildenafil Citrate Orally Disintegrating Tablets. Under the agreement, ANVITA will place orders after obtaining Indonesian registration approvals for these products. For Finasteride and Tadalafil Capsules, the minimum annual order amount for the first three years totals $10.3154 million. Tainkang has initiated overseas registration for this product and aims to realize order revenue as soon as possible.
Furthermore, the company's international expansion extends to multiple countries, with several products having signed distribution or sales contracts with pharmaceutical companies in Malaysia, Nigeria, Saudi Arabia, and others. The successful registration of "Aitingjiu" in Indonesia represents a substantial breakthrough in Tainkang's internationalization strategy. Moving forward, the company will leverage ANVITA's local resources to steadily advance product commercialization, further expand its presence in emerging Southeast Asian markets, and capitalize on market growth dividends to open new growth avenues.
Guangdong Tainkang Pharmaceutical recently announced that its core product "Aitingjiu" Dapoxetine Hydrochloride Tablets have successfully obtained registration approval from Indonesia's National Agency for Drug and Food Control (BPOM). This achievement not only marks a breakthrough in the company's overseas product registration but also makes the drug the first generic version of its kind in Indonesia, signaling the official start of the company's commercialization process in the Southeast Asian market. The drug is a first-line treatment recommended by domestic and international guidelines for premature ejaculation, offering good clinical benefits, low safety risks, and rapid onset. It was independently developed by the company and launched in the domestic market in August 2020. Currently, the product holds a leading position in the domestic off-channel market for Dapoxetine Hydrochloride, particularly with a strong brand advantage in offline retail, laying a solid foundation for its overseas expansion.
To advance its market presence in Indonesia, Tainkang had previously reached a cooperation agreement and signed a distribution agreement with PT ANVITA PHARMA INDONESIA ("ANVITA"), a leading Indonesian biopharmaceutical company. ANVITA specializes in high-end small molecule API R&D and production as well as CDMO services, with a GMP-certified production base in Indonesia and over ten commercialized products. This partnership will provide strong support for the market promotion of "Aitingjiu" in Indonesia. Indonesia, as the world's fourth most populous country with over 270 million people, is one of the largest and fastest-growing pharmaceutical markets in Southeast Asia. Benefiting from universal healthcare programs, significant unmet clinical needs, and favorable policies, Indonesia's pharmaceutical market reached $11 billion in 2023, with a compound annual growth rate of 10%, and is expected to exceed $15 billion by 2025.
Additionally, Indonesia was China's largest pharmaceutical trade partner in ASEAN in 2024, with bilateral pharmaceutical trade growing at a compound annual rate of 12% over the past five years. The entry of "Aitingjiu" as a first generic is expected to leverage first-mover advantages to capture market share. Besides "Aitingjiu," Tainkang has also signed distribution agreements with ANVITA for "Aitinglie" Finasteride and Tadalafil Capsules, "Aitingwei" Tadalafil Tablets, and "Aitingda" Sildenafil Citrate Orally Disintegrating Tablets. Under the agreement, ANVITA will place orders after obtaining Indonesian registration approvals for these products. For Finasteride and Tadalafil Capsules, the minimum annual order amount for the first three years totals $10.3154 million. Tainkang has initiated overseas registration for this product and aims to realize order revenue as soon as possible.
Furthermore, the company's international expansion extends to multiple countries, with several products having signed distribution or sales contracts with pharmaceutical companies in Malaysia, Nigeria, Saudi Arabia, and others. The successful registration of "Aitingjiu" in Indonesia represents a substantial breakthrough in Tainkang's internationalization strategy. Moving forward, the company will leverage ANVITA's local resources to steadily advance product commercialization, further expand its presence in emerging Southeast Asian markets, and capitalize on market growth dividends to open new growth avenues.