ACA Pharma, an end-to-end commercialization partner for China & Southeast Asia, helps Eagle Pharmaceuticals secure regulatory approval in Macau for RYANODEX® in under 90 days.
NEW YORK, July 3, 2025 /PRNewswire-PRWeb/ -- MACAU – ACA Pharma proudly announces the rapid regulatory approval of Ryanodex® (dantrolene sodium) in Macau, in collaboration with Eagle Pharmaceuticals. Achieved within an impressive 90 days and without local clinical trials, this milestone significantly enhances emergency medical response capabilities.
Ryanodex® offers critical advantages in emergency settings, notably its ultra-fast reconstitution time—just one minute compared to the standard 20 minutes required by existing alternatives. This difference is potentially lifesaving during acute medical emergencies.
Registration processes for Ryanodex® are also currently underway in Hong Kong and Singapore, regions known for their robust government-backed insurance support for innovative treatments.
Following receipt of the final drug certificate and associated regulatory documents, ACA Pharma has initiated discussions with Guangdong Greater Bay Area (GBA) authorities to begin immediate market entry into Mainland China via 45 leading hospitals in the region and to pursue fast-track national registration in China via the clinical urgent-use pathway, which similarly circumvents the requirement for local clinical trials.
ACA Pharma's Macau team maintains a distinguished track record, successfully completing 54 fast-track new drug registrations over the past two years, representing U.S. and European pharmaceutical innovators, all achieved with a 100% approval rate.
This approval underscores ACA Pharma's ongoing commitment to facilitating expedited market access in China through its exclusive regulatory pathway in Macau, continuing its successful collaboration with global biopharma leaders like Eagle Pharmaceuticals.
About ACA Pharma
ACA Pharma, is a New York-based pharmaceutical export company specializing in facilitating the rapid market entry and commercialization of U.S. and European-approved pharmaceutical products across Asia, starting with the Guangdong-Hong Kong-Macao Greater Bay Area ("Greater Bay Area"). This is achieved through the implementation of the Macau and APAP strategies, detailed below:
- Macau Rapid Registration Strategy: A 30-90 day streamlined process enabling swift market entry into China and Asia for unregistered products, leveraging Macau as a gateway to the Greater Bay Area and broader national markets, while supporting expansions through Hong Kong and Singapore registrations.
ACA Pharma has demonstrated remarkable success in product registration and strategic partnerships: 1) Their Macau Wuzhou Pharma team achieved a 100% success rate, registering over 54 European and American pharmaceutical products over the past two years 2) Their Macau Wuzhou Pharma team established a strategic partnership with China's top three national pharmaceutical distributors, and 3) This collaboration has significantly enhanced their market access, distribution, and logistics capabilities in China's state-owned enterprise-driven market. These accomplishments underscore ACA Pharma's expertise in navigating the complex regulatory landscape and our ability to forge valuable industry partnerships. ACA Pharma's proven track record positions them as a reliable partner for originators seeking efficient market entry and distribution in the Greater Bay Area, and potentially other Southeast Asian markets.
- APAP (Asian Patients Access Program) Strategy: A complementary solution for rapid Asian market entry, ideal for geopolitical concerns or products requiring specialty pharmacy handling. APAP facilitates sales of injectables, tablets, and capsules in unregistered Asian countries, even for products already registered in China.
The APAP strategy capitalizes on ACA Pharma's established relationships with reputable U.S. wholesalers to procure products directly with the originator's approval. This streamlined approach allows purchases at standard U.S. market prices without requiring registrations in Macau, Hong Kong, or Singapore. Additionally, it mitigates geopolitical risks and meets urgent healthcare needs across Asia by leveraging ACA Pharma's extensive network and existing demand from self-paying patients.
- Dual Strategy: The integration of Macau registration and APAP provides originators with a dual pathway, rapid initial market presence via APAP and sustained growth through Macau registration. Especially valuable for U.S.-approved oncology and orphan drugs, this synergy accelerates coverage in unregistered Asian markets.
Notably, ACA Pharma assumes all upfront costs related to product registration, commercialization, and logistics, ensuring that originators bear no initial investment. Key advantages of this model include: 1) Full retention of intellectual property rights by the originators, 2) Immediate and ongoing market returns for the originators, and 3) No financial risk or investment required from the originators. This approach provides a risk-free opportunity for originators to enter new markets, leveraging ACA Pharma's expertise and resources for swift market penetration while maintaining full control over their intellectual property.
Media Contact
Mike Zhou, ACA Pharma, 1 (718) 790-5069, [email protected], www.acapharma.net
SOURCE ACA Pharma
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