NEW YORK, Oct. 9, 2025 — ACA Pharma is pleased to announce that it has signed an exclusive distribution agreement with Eagle Pharmaceuticals, Inc. for ACA Pharma to commercialize Ryanodex® (dantrolene sodium for injection) and Barhemsys® (amisulpride injection) across Hong Kong, Macau, Singapore, and Greater China.

Ryanodex and Barhemsys are innovative hospital products with established use in the U.S. Ryanodex is indicated for the treatment of malignant hyperthermia and for the prevention of malignant hyperthermia in patients at high risk. Barhemsys is indicated in adults for the prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class as well as the treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.

ACA Pharma has already completed fast-track registration in Macau (30–90 days) for Ryanodex, while Barhemsys registration is still in progress, and is proceeding in parallel with Hong Kong and Singapore filings. In addition, ACA Pharma’s Macau team has scheduled meetings with China’s Center for Drug Evaluation (CDE) to prepare for national registration, while also working with Hainan authorities to include Ryanodex and Barhemsys on the Urgently Needed Clinical Medicines List for accelerated hospital adoption.

Despite the presence of local generics in China, imported originator medicines continue to hold a strong position and competitive advantage within the hospital sector. Leveraging ACA Pharma’s established fast-track regulatory pathways and its broader global distribution alliances, both products are also being positioned for expansion into Latin America, Asia, Europe, and other unregistered regions — bringing life-saving hospital therapies to a significantly wider patient population.

This agreement allows ACA Pharma to quickly provide healthcare professionals and patients with access to critical hospital medicines,” said Mike Zhou, CEO of ACA Pharma. “With Ryanodex already expanding into the Middle East and India through local registration and wholesale partnerships, and Barhemsys progressing toward national registration in China, we see significant opportunities to address urgent unmet needs across multiple regions.

About ACA Pharma

Founded in 1997, ACA Pharma is a U.S.-based pharmaceutical distributor providing end-to-end commercialization for U.S. and European originators across Greater China and Southeast Asia. ACA specializes in fast-track regulatory pathways, market access, medical affairs, supply chain, and commercial execution. Leveraging its Macau Fast Track platform, ACA enables patient access in as little as 30–90 days, reaching leading hospitals in the Greater Bay Area and beyond. For pediatric and orphan drugs, ACA also coordinates direct entry into China’s top pediatric hospitals and children’s medical centers — covering over 95% of rare disease patients nationwide — through group procurement across 45 designated hospitals, without requiring national registration. Learn more at www.acapharma.net.

About Eagle Pharmaceuticals, Inc.

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Additional information is available on Eagle’s website at www.eagleus.com.

About Ryanodex®

• Ryanodex® (dantrolene sodium for injection) is FDA-approved for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures, and for the prevention of malignant hyperthermia in patients at high risk.

Important Safety Information

• RYANODEX® is not a substitute for appropriate supportive measures in the treatment of malignant hyperthermia (MH), including discontinuing use of MH-triggering anesthetic agents, managing the metabolic acidosis, instituting cooling when necessary, and administering diuretics to prevent late kidney injury due to myoglobinuria (the amount of mannitol in RYANODEX® is insufficient to maintain diuresis).
  
  
• RYANODEX® is associated with skeletal muscle weakness such as loss of grip strength and weakness in the legs, as well as drowsiness, dizziness, dysphagia, dyspnea, and decreased inspiratory capacity. Patients should not be permitted to ambulate without assistance until they have normal strength and balance. Care must be taken to prevent extravasation of RYANODEX® into the surrounding tissue due to the high pH of the reconstituted RYANODEX® suspension and potential for tissue necrosis.
  
  
• RYANODEX® full Prescribing Information can be found at www.RYANODEX.com

About Barhemsys®

• Barhemsys® (amisulpride injection) is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist, FDA-approved in adults for:
  
  
• prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class
  
  
• treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis

Important Safety Information

Contraindication

• Barhemsys is contraindicated in patients with known hypersensitivity to amisulpride.

QT Prolongation

• Barhemsys causes dose- and concentration-dependent prolongation of the QT interval. The recommended dosage is 5 mg or 10 mg as a single intravenous (IV) dose infused over 1 to 2 minutes.
  
  
• Avoid Barhemsys in patients with congenital long QT syndrome and in patients taking droperidol.
  
  
• Electrocardiogram (ECG) monitoring is recommended in patients with pre-existing arrhythmias/cardiac conduction disorders, electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval.

Adverse Reactions

• Common adverse reactions reported in ≥ 2% of adult patients who received Barhemsys 5 mg (N=748) and at a higher rate than placebo (N=741) in clinical trials for the prevention of PONV were: chills (4% vs. 3%), hypokalemia (4% vs. 2%), procedural hypotension (3% vs. 2%), and abdominal distention (2% vs. 1%).
  
  
• Serum prolactin concentrations were measured in one prophylaxis study where 5% (9/176) of Barhemsys-treated patients had increased blood prolactin reported as an adverse reaction compared with 1% (1/166) of placebo-treated patients.
  
  
• The most common adverse reaction, reported in ≥ 2% of adult patients who received Barhemsys 10 mg (N=418) and at a higher rate than placebo (N=416), in clinical trials for the treatment of PONV was infusion site pain (6% vs. 4%).

Use in Specific Populations

• Pregnancy

Available data with amisulpride use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

• Lactation
  • Amisulpride is present in human milk. There are no reports of adverse effects on the breastfed child and no information on the effects of amisulpride on milk production.
    
    
  • Barhemsys may result in an increase in serum prolactin levels, which may lead to a reversible increase in maternal milk production. In a clinical trial, serum prolactin concentrations in females (n=112) increased from a mean of 10 ng/mL at baseline to 32 ng/mL after Barhemsys treatment and from 10 ng/mL to 19 ng/mL in males (n=61). No clinical consequences due to elevated prolactin levels were reported.
    
    
  • To minimize exposure to a breastfed infant, lactating women may consider interrupting breastfeeding and pumping and discarding breast milk for 48 hours after receiving a dose of Barhemsys.

• Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

• Geriatric Use

No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Drug Interactions

• Barhemsys causes dose- and concentration-dependent QT prolongation. To avoid potential additive effects, avoid use of Barhemsys in patients taking droperidol.
  
  
• ECG monitoring is recommended in patients taking other drugs known to prolong the QT interval (e.g., ondansetron).
  
  
• Reciprocal antagonism of effects occurs between dopamine agonists (e.g., levodopa) and Barhemsys. Avoid using levodopa with Barhemsys.

• To report SUSPECTED ADVERSE REACTIONS, contact Acacia Pharma at 1-877-357-9237 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Media Contact

ACA Pharma: team@acapharma.net

Media Contact

Mike Zhou, ACA Pharma, 1 (718) 790-5069, team@acapharma.net, www.acapharma.net

Read the full press release on PRWeb.

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.

To learn more about RYANODEX® and Eagle Pharmaceuticals, please refer to ACA Pharma’s Oct 9, 2025 PRWeb press release.

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.

To learn more about Barhemsys® and Eagle Pharmaceuticals, please refer to ACA Pharma’s Oct 9, 2025 PRWeb press release.

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.

To learn more about RYANODEX® and Eagle Pharmaceuticals, please refer to ACA Pharma’s Oct 9, 2025 PRWeb press release.

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.