1. Date of occurrence: 115/06/11 2. Contract or commitment counterparty: Samil Pharmaceutical Co., Ltd 3. Relationship with the company: None 4. Contract or commitment start and end dates (or termination date): 115/06/11 5. Main content (not applicable for termination): The company has signed an exclusive licensing agreement with Samil Pharmaceutical, granting them the exclusive commercialization rights for APP13007 (Clobetasol Propionate Ophthalmic Suspension 0.05%) in the Vietnamese market. 6. Restrictive clauses (not applicable for termination): As per the agreement. 7. Commitments (not applicable for termination): None. 8. Other important agreements (not applicable for termination): None. 9. Impact on the company's finances and business: This licensing transaction includes an upfront payment, regulatory milestone payments, and royalties, with other commercial terms set during the agreement period. The specific details of the contract are not disclosed due to mutual confidentiality agreements. The annual number of cataract surgeries in Vietnam has already reached 300,000 cases, with overall market demand maintaining a stable growth of 5% annually. According to 2024 IQVIA sales data, the total annual sales of the ophthalmic steroid market in Vietnam reached US$4.26 million. By leveraging the company's core expertise and development focus on ophthalmic drugs, it will be beneficial for the sales of our new drug APP13007 for post-ophthalmic surgery inflammation and pain treatment in the Vietnamese market, bringing positive benefits to the company's financial and business development. 10. Specific purpose: To license the commercialization and sale of the company's product in the local market. 11. Other matters to be noted (If the subject of the event or decision is a publicly issued company or above, this major information also meets the requirements of Article 7, Item 8 of the Enforcement Rules of the Securities Transaction Act regarding matters that have a significant impact on shareholder equity or securities prices): (1) New drug development involves long timelines, high investment costs, and no guarantee of success. These factors may expose investments to risk, and investors should exercise careful judgment and caution. (2) Samil Pharmaceutical Co., Ltd. (000520.KS), established in 1947 and headquartered in Seoul, South Korea, is a pharmaceutical company with expertise in the fields of ophthalmology, hepatobiliary-gastroenterology, and central nervous system drugs. As part of its global expansion strategy, Samil has established overseas subsidiaries in North America, Vietnam, and Japan. Through continuous collaboration with over 10 global pharmaceutical companies such as Samsung Bioepis, Abbvie, Nicox, and Thea, Samil is actively expanding its CMO/CDMO services in the ophthalmology sector. Its advanced facility in Ho Chi Minh City, Vietnam, has obtained WHO GMP certification. The company is actively pursuing additional global certifications, including KGMP, cGMP, and EUGMP, as part of its strategy to expand into global markets.
FACT BOX
- Source: PR Times
- Category: Partnership
- Organizations: Samil Pharmaceutical Co., Ltd / Samsung Bioepis / Abbvie
- Dates in source: 115/06/11 / 2024
- Products / services: APP13007