We’re excited to announce a strategic partnership between KYBORA and ACA Pharma, combining ACA Pharma’s innovative 30–90 day market entry strategy via Macau with KYBORA’s deep network in the global biopharma industry.

Through this collaboration, KYBORA will work with ACA Pharma to introduce its fast-track registration and commercialization platform to biopharma companies worldwide, helping transform how novel therapies enter the Chinese market, particularly in rare diseases, pediatrics, and other areas of high unmet need.

Why it matters:

• ACA Pharma’s Macau registration model enables regulatory approval in as little as 30–90 days, providing direct access to top-tier hospitals in the Greater Bay Area, one of the fastest-growing healthcare hubs in Asia.
• No upfront investment is required from the originator: ACA covers registration, logistics, and commercialization, creating a zero-risk pathway to access China and Southeast Asia.
• KYBORA brings decades of dealmaking and strategic advisory expertise to identify and match promising U.S. and European innovations with ACA Pharma’s unique platform.

We look forward to helping more innovative therapies reach patients in China and across Asia, faster and more efficiently than ever before.

First Amendment to Exclusive Distribution Agreement adds Hong Kong, Macau, Singapore, China, India, UAE, Qatar, Kuwait, and Oman

New York, NY — Eagle Pharmaceuticals, Inc. (“Eagle”) and ACA Pharma announced the First Amendment to their Exclusive Distribution Agreement for RYANODEX® (dantrolene sodium). The amendment expands ACA Pharma’s exclusive distributor rights to the following markets: Hong Kong, Macau, Singapore, China, India, the United Arab Emirates, Qatar, Kuwait, and Oman.

About RYANODEX®

RYANODEX® (dantrolene sodium) is indicated for the treatment of malignant hyperthermia and for the prevention of malignant hyperthermia in patients at high risk. Please refer to full prescribing information in applicable jurisdictions.

Exclusive commercialization covers Macau, Hong Kong, Singapore, Guangdong and Mainland China; parallel registrations planned, with Macau fast-track targeted in under 90 days

New York, NY — Eagle Pharmaceuticals (“Eagle”) and ACA Pharma today announced a strategic agreement under which ACA Pharma will serve as Eagle’s exclusive distributor and commercialization partner for Barhemsys® (amisulpride injection) across Macau, Hong Kong, Singapore, Guangdong and Mainland China. The parties will pursue parallel registrations in Macau, Hong Kong, Singapore, and Mainland China, with Macau fast-track authorization targeted in <90 days.

In addition to Macau, ACA Pharma will evaluate the Greater Bay Area (GBA) pathway where applicable. Given the presence of domestic generic competitors, the GBA route may not be available; ACA will proceed with Mainland China national registration regardless.

Why it matters

• Faster access for patients: ACA’s Macau fast-track pathway targets authorization in under 90 days, enabling early access at top centers while broader registrations proceed.

• Regional scale: The collaboration spans Macau, Hong Kong, Singapore, Guangdong, and Mainland China, creating a unified go-to-market plan across key hubs.

• Turnkey execution: ACA will lead regulatory, market access, distribution, medical education, and pharmacovigilance, aligning launch sequencing across jurisdictions.

“Barhemsys addresses a clear peri-operative need. We’re executing a parallel-track playbook—Macau in <90 days, HK/SG in process, and Mainland registration on a defined path,” said Mike Zhou, CEO, ACA Pharma.

About Barhemsys®

Barhemsys® (amisulpride injection) is a hospital-administered antiemetic indicated for the management of postoperative nausea and vomiting (PONV).

ACA Pharma, in collaboration with Eagle Pharmaceuticals, has successfully registered Ryanodex in Macau in under 90 days, without clinical trials, through ACA Pharma’s Macau Fast-Track pathway.  This regulatory approval represents a major milestone in making lifesaving treatments more accessible. Ryanodex’s ultra-fast reconstitution (1 minute vs. 20 minutes) makes it a game-changer in emergency settings.

Parallel registration is already underway in Hong Kong and Singapore, both of which offer government insurance coverage for innovative treatments. Once the final drug certificate and support letters are received (expected in two weeks), we will initiate discussions with Guangdong Greater Bay Area (GBA) authorities to explore potential entry into 45 hospitals and fast-track national registration in China under the clinical urgent-use pathway—bypassing the need for local clinical trials.

Over the past two years, our ACA Pharma Macau team has successfully completed 54 fast-track new drug registrations for U.S. and European originators with a 100% success rate. We remain committed to partnering with global biopharma innovators like Eagle Pharmaceuticals to accelerate access to China’s market through our exclusive Macau regulatory pathway.

Yesterday, we celebrated a significant milestone with the issuance of the first prescription for Deflazacort (marketed as Emflaza in the U.S.), an orphan drug  our Macau team registered, directly at Beijing’s prestigious Union Hospital. This event underscores our commitment to enhancing access to treatments for rare diseases throughout China.

Milestone for ACA Pharma and Patient Care in China

We are thrilled to share an important milestone for our Macau team and patient care in China. Yesterday, our orphan drug, Diftotecan, was prescribed for the first time at Peking Union Medical College Hospital in Beijing. This event marks a significant advancement in the treatment of rare diseases in the region.

Media Coverage

The ceremony received extensive media coverage, with reports from major outlets including CCTV, Xinhua, Beijing Daily, Beijing Evening News, Health News, and Science and Technology Daily. The event was also featured prominently in last night’s CCTV news broadcast, underscoring the significance of this achievement.

• CCTV’s feature on this milestone. Watch here.
• Further reading on the event. Read more.

Transforming Healthcare Access in China with Fast-Track Drug Registration in Macau.

Last year alone,  our Macau team sucessfully registered over 40 new drugs from Europe and the United States. We continue to provide the fastest pathway for all pharmaceutical companies with new and orphan drugs to enter the Chinese market through our 30 to 90-day registration process in Macau. With a 100% success rate, zero investment required, and a turnaround time of 30 to 90 days, we offer unparalleled support for originators.