DUBLIN, IE / February 9, 2026 / Ayrmid, Ltd. (“Ayrmid” or the “Company”), the parent company of Gamida Cell Inc., today announced that it has appointed ACA Pharma as its exclusive distributor for Omisirge (Omidubicel-onlv) and granted ACA Pharma exclusive rights to seek registration and to distribute Omisirge across the following jurisdictions: Mainland China, Hong Kong SAR, Macau SAR, Mongolia, Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam and Timor-Leste.

Under the terms of the agreement, ACA Pharma will hold exclusive rights to register and distribute Omisirge across the Territory; the parties will prioritize specific jurisdictions for regulatory and launch planning based on local requirements and commercial considerations. Initial efforts may focus on lighthouse centers in Macau and Singapore, with additional jurisdictions assessed over time.

Dr. Joe Wiley, CEO and Chairman of Ayrmid commented: “This agreement represents continued progress as we expand access for patients in existing and new territories. Omisirge represents an important advancement in cell therapy and we look forward to working with the team at ACA as we continue to advance our innovative therapies to help patients with serious unmet medical needs.”

Mike Zhou, CEO of ACA Pharma commented: “This appointment reflects a shared commitment to responsibly expanding access to Omisirge for appropriate patients across Greater China and Southeast Asia. ACA Pharma’s platform is built for complex specialty products-combining regulatory execution, hospital launch capability, and end-to-end distribution-while maintaining the highest standards for quality and patient safety.”

About Omisirge

Omisirge is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from cord blood. Omisirge is approved in the United States for: (1) adults and pediatric patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning to reduce time to neutrophil recovery and incidence of infection; and (2) adults and pediatric patients 6 years of age and older with severe aplastic anemia following reduced-intensity conditioning.

About Ayrmid Ltd. and Gamida Cell

Ayrmid Ltd. is the parent company of Gamida Cell Inc., a pioneering cell therapy company developing novel treatments designed to turn cells into powerful therapeutics. Gamida Cell Inc. currently has two FDA approved products on the market in the US, namely Omisirge^® (please see the current full Prescribing Information, including boxed warning, here) and APHEXDA^® (please see the current full Prescribing Information here). Gamida Cell operates as a wholly owned subsidiary of Ayrmid Limited, a UK entity. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.

Contacts: Media, Investors / Business Development: bd@ayrmid.com

About ACA Pharma

Founded in 1997, ACA Pharma is a U.S.-headquartered company specializing in fast-track registrations, early access programs, and end-to-end commercialization for innovative medicines and medical devices worldwide. The company is best known for its Macau Fast-Track platform for medicines and Hong Kong Fast-Track pathway for advanced devices, which can enable market entry in as little as 30-90 days in Macau and approximately three months in Hong Kong. These hubs then serve as launchpads to bridge into mainland China via the Greater Bay Area and other national pilot zones, with the real-world evidence generated supporting accelerated national approvals – particularly for products addressing unmet medical need, clinically urgent conditions, or rare diseases. Learn more at www.acapharma.net

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To learn more about Omisirge^®, Ayrmid Ltd. or Gamida Cell, please refer to Ayrmid Pharma’s February 9, 2026 full press release on ACCESS Newswire.

ACA Pharma and Azurity Pharmaceuticals are pleased to announce that they have entered into an exclusive distribution partnership under which ACA Pharma will commercialize Ferabright™ (ferumoxytol injection) across Macau, Hong Kong, Singapore, the Guangdong–Hong Kong–Macao Greater Bay Area (GBA) and Mainland China.

Ferabright is an iron-based MRI contrast agent indicated in the United States for imaging of the brain in adults with known or suspected malignant neoplasms, helping visualize lesions with a disrupted blood-brain barrier. Ferabright is based on superparamagnetic iron oxide nanoparticles and is processed through the body’s natural iron metabolism pathways, offering an alternative to traditional gadolinium-based agents and the potential to reduce concerns about long-term retention of heavy metals.

“We are excited to expand our collaboration with ACA Pharma to bring Ferabright to patients and clinicians across this important region,” said Ronald Scarboro, CEO of Azurity Pharmaceuticals. “With ACA’s established infrastructure and fast-track pathways, we see an opportunity to responsibly introduce this innovative imaging option in markets where the need for advanced brain tumor diagnostics is substantial.”

Under the agreement, ACA Pharma will pursue marketing authorization for Ferabright in Hong Kong, Macau, and Singapore, leveraging its Macau Fast-Track platform and Hong Kong/Singapore fast-track pathways in parallel with Feraheme® submissions. In the Greater Bay Area, ACA intends to integrate Ferabright into its existing network of designated hospitals, with the aim of enabling earlier access for patients while longer-term national registration in Mainland China is prepared.

“This expanded partnership builds on our work with Feraheme and allows us to offer physicians a complementary, iron-based MRI contrast option for patients with brain tumors,” said Mike Zhou, CEO of ACA Pharma. “Working closely with Azurity, we plan to combine fast-track access routes with real-world evidence generation, so that appropriate patients in our region can benefit from Ferabright as global experience grows.”

ACA Pharma and Azurity plan to collaborate with leading neuroradiology and neuro-oncology experts across the Greater Bay Area and other key centers in China and Southeast Asia to support responsible adoption of Ferabright. Educational activities are expected to focus on patient selection, imaging protocols, and the role of iron-based contrast agents as part of the broader MRI toolkit, including for patients who may not be candidates for gadolinium-based products.

About ACA Pharma

Founded in 1997, ACA Pharma is a U.S.-headquartered company specializing in fast-track registrations, early access programs, and end-to-end commercialization for innovative medicines and medical devices across Greater China and Southeast Asia. The company’s Macau Fast-Track and Hong Kong Fast-Track platforms can enable market entry for priority products in a matter of months, with these hubs serving as launchpads into the Greater Bay Area and other national pilot zones. ACA Pharma’s integrated capabilities span regulatory strategy, market access, medical affairs, pharmacovigilance, supply chain, and commercial execution. Learn more at www.acapharma.net

About Azurity Pharmaceuticals

Azurity Pharmaceuticals is a privately held company committed to delivering innovative, high-quality medicines for overlooked patients. Azurity’s global footprint is over 50 countries, with a diversified portfolio of 50+ medicines spanning 10 dosage forms and 10 key therapeutic areas. Our medicines have benefited millions of people. For more information, visit www.azurity.com.

About Ferabright™ (ferumoxytol injection)

Ferabright™ (ferumoxytol injection) is an iron-based contrast agent indicated in the United States for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms of the brain to visualize lesions with a disrupted blood-brain barrier. Ferabright uses superparamagnetic iron oxide nanoparticles designed to enhance image contrast and delineation of brain tumors compared with non-contrast MRI. Because Ferabright is processed through normal iron metabolism pathways, it offers a non-gadolinium alternative and can be used in patients with renal insufficiency in accordance with its approved label.

For full U.S. prescribing information, including important safety information and Boxed Warning, please visit Ferabright.com.

To learn more about Ferabright™ or Azurity Pharmaceuticals, please refer to ACA Pharma’s Janurary 14, 2026 full press release on EIN Presswire.

Ferabright™ and Feraheme® are registered trademarks of Covis Pharma GmbH, a wholly-owned subsidiary of Azurity Pharmaceuticals. This press release may contain forward-looking statements subject to risks and uncertainties; actual results may differ materially. Subject to applicable law, rules, or regulations, the parties do not have any and undertake no obligations to update or otherwise revise the forward-looking statements in this press release, whether as a result of new information, future events or developments, or otherwise.

ACA Pharma today announced a significant expansion of their exclusive territory for RYANODEX^® (dantrolene sodium) outside the United States.

Ryanodex^® is indicated for the treatment of malignant hyperthermia and for the prevention of malignant hyperthermia in patients at high risk. Eagle Pharmaceuticals, Inc. is the developer and manufacturer of Ryanodex^®, and ACA Pharma acts as Eagle’s primary distribution partner for Ryanodex^® outside the United States, with territory-specific exclusivities in parts of Asia, the Middle East, Europe and Latin America.

ACA Pharma has historically focused on launching RYANODEX^® in select Asia-focused markets, including Hong Kong, Macau, Singapore, the Guangdong Greater Bay Area and mainland China, India, and countries in the Gulf region. Under the expanded collaboration, ACA Pharma’s exclusive territory now covers a broad range of additional markets across Europe, Latin America, the Middle East and Asia-Pacific.

The expanded territory where ACA Pharma is the exclusive distributor now includes:

Hong Kong, Macau, Singapore, Guangdong Greater Bay Area, mainland China, India, the United Arab Emirates (“UAE”), Qatar, Kuwait, Oman, Germany, France, United Kingdom, Italy, Spain, Poland, Netherlands, Belgium, Sweden, Austria, Switzerland, Portugal, Czechia, Greece, Romania, Hungary, Denmark, Norway, Finland, Ireland, Bulgaria, Croatia, Slovakia, Slovenia, Lithuania, Latvia, Estonia, Luxembourg, Malta, Iceland, Russia; Brazil, Argentina, Chile, Peru, Columbia, Ecuador, Venezuela, Bolivia, Paraguay, Uruguay, Guyana, Suriname, Mexico; Indonesia, Philippines, Vietnam, Malaysia, Thailand, Myanmar, Cambodia, Laos; Bangladesh, Japan, South Korea, Taiwan; Pakistan; Israel; Australia, and New Zealand.

“We are honored that Eagle has entrusted ACA Pharma with an expanded ex-U.S. footprint for RYANODEX^®,” said Mike Zhou, CEO, ACA Pharma. “Building on our experience across Asia, we are now actively working with leading hospital systems, anesthesiology societies and, where appropriate, established local partners across these new markets to support registration, clinician education and reliable supply of RYANODEX^®.”

As part of this expansion, ACA Pharma is prioritizing engagement with key opinion leaders in anesthesiology and intensive care, as well as major hospital groups and qualified regional collaborators, to design tailored market-access and implementation plans for each country included in the Territory. Healthcare institutions and organizations interested in collaborating to improve local access to RYANODEX^® may contact ACA Pharma at team@acapharma.net or https://acapharma.net/.

About ACA Pharma

Founded in 1997, ACA Pharma is a U.S.-headquartered company specializing in fast-track registrations, early access programs, and end-to-end commercialization for innovative medicines and medical devices worldwide. The company is best known for its Macau Fast-Track platform for medicines and Hong Kong Fast-Track pathway for advanced devices, which can enable market entry in as little as 30–90 days in Macau and approximately three months in Hong Kong. These hubs then serve as launchpads to bridge into mainland China via the Greater Bay Area and other national pilot zones, with the real-world evidence generated supporting accelerated national approvals — particularly for products addressing unmet medical need, clinically urgent conditions, or rare diseases. Learn more at www.acapharma.net

To learn more about RYANODEX® or Eagle Pharmaceuticals, please refer to ACA Pharma’s November 24, 2025 full press release on EIN Presswire.

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.

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.