Regulatory Approvals & Product Pipeline

Across Asia and key global markets

Faster Approvals. Faster Access. Better Outcomes.

Welcome to our Approvals page. Below are selected commercial products, regulatory approvals and registrations supported by ACA Pharma and our local teams across Macau, Hong Kong, Singapore, Mainland China and other key global markets in recent years. Several additional products are currently in late-stage regulatory review. Select blue links in the tables provide sample approval certificates.

Products Main Indications Stage Result Partners
Dermatology
Ruxolitinib Cream Facial vitiligo Approved Macau Incyte
Axhidrox Severe primary axillary hyperhidrosis Approved HK, Macau, Guangdong, Hainan Dr. August Wolff GmbH & Co. KG Arzneimittel
Ophthalmic Pipeline
Tyrvaya Dry eye disease Approved Macau JIXING Pharmaceuticals
T-SPORIN Eye Drops Dry eye associated with keratoconjunctivitis sicca Commercial Pipeline Macau HANLIM PHARM. CO., LTD.
Latropine 0.01% Single Pack Mydriasis, cycloplegia Approved Sole Agent in Greater China Wufu Chemical Pharmaceutical Co., Ltd.
Latropine 0.01% Multi-Pack Mydriasis, cycloplegia Approved Sole Agent in Greater China Wufu Chemical Pharmaceutical Co., Ltd.
VisuXL® 10ml Mild to moderate dry eye Approved HK, Macau exclusive Visufarma
Naviblef Daily Care Eyelid cleansing Approved Greater China Visufarma
VisuXL® Gel Moderate to severe dry eye Approved Greater China Visufarma
TREHAPAN Lubrication for dry eye Approved Greater China Visufarma
Visu Ectoine Eye irritation relief Approved Greater China Visufarma
VisuEVO Evaporative dry eye Approved Greater China Visufarma
Naviblef Intensive Care Severe eyelid inflammation cleansing Approved Greater China Visufarma
COQUN Adjunctive support in glaucoma Approved Greater China Visufarma
Rare Disease Pipeline
Defal Tablets Duchenne muscular dystrophy Approved Sole Agent in Greater China FAES FARMA
Defal Oral Liquid Duchenne muscular dystrophy Approved Sole Agent in Greater China FAES FARMA
Efmody Congenital adrenal hyperplasia (CAH) Approved Hong Kong and Macau Immedica Pharma AB
General Surgery
Ryanodex Malignant hyperthermia Macau Approved; Registrations in Progress 70 markets across Europe, MENA, Asia and Latin America Eagle Pharmaceuticals
Barhemsys Post-operative nausea and vomiting (PONV) Macau Approved; Registrations in Progress Macau, Hong Kong, Singapore and China Eagle Pharmaceuticals
Vascular / Renal
Venosmil Symptoms of chronic venous insufficiency Commercial Pipeline Sole Agent in Greater China FAES FARMA
Citra-Lock Catheter locking solution for hemodialysis catheters Commercial Pipeline Hong Kong and Macau Dirinco AG
Gastroenterology / Hepatology
Alginos Oral Liquid Reflux pain relief Approved Hong Kong and Macau Taiwan Toyo
Alginos Tablet Reflux pain relief Approved Hong Kong and Macau Taiwan Toyo
LAENNEC Improvement of liver function in chronic liver disease Commercial Pipeline Hong Kong and Macau Japan Bio Products Co., Ltd.
Neurology
Myopridin Muscle spasms Commercial Pipeline Sole Agent in Greater China Strathmann GmbH & Co. KG
Clobazam Oral Suspension Epilepsy Commercial Pipeline Hong Kong and Macau Syri Limited t/a Thame Laboratories
Respiratory / Infectious Disease
Bronchitol CF lung function improvement Approved HK, Macau exclusive Pharmaxis
Trogarzo Treatment-experienced patients with multidrug-resistant HIV Approved HK, Macau exclusive Theratechnologies
Urology / Gynecology
Booster-Strovac Recurrent urinary tract infections Approved HK, Macau, Guangdong, Hainan Strathmann
Strovac Recurrent urinary tract infections Approved Greater China Strathmann
DEXELL VUR 1ml Vesicoureteral reflux Approved Greater China ISTEM MEDICAL
HYACYST Interstitial cystitis and painful bladder syndrome Approved Greater China ISTEM MEDICAL
DAFNEGIN Vulvovaginal Candida infections Commercial Pipeline Sole Agent in Greater China S&R Farmaceutici S.p.A.
Oncology
CISPLACEL Local chemotherapy for malignant brain and head and neck tumors Commercial Pipeline Macau, Guangdong, Hainan BSU
PROSPIDELONG Local treatment of malignant tumors, including disseminated gastric cancer Commercial Pipeline Macau, Guangdong, Hainan BSU
Health Products
Dynamogen Oral Solution Loss of appetite / nutritional support Approved Sole Agent in Greater China FAES FARMA
Potenciator 5G Amino acid deficiency / convalescence Approved Greater China FAES FARMA
Visufly Floaters Approved Greater China Visufarma
Other Pipelines
Placentex Wound healing / tissue repair Approved Greater China Mastelli
Emorsan Gel Hemorrhoid therapy Approved Greater China Mastelli
BRIX3000 (Papain Gel) Caries removal Approved Greater China Brix Medical Science
Iron Therapy / Imaging
Feraheme Iron deficiency anemia (IDA), including CKD Macau Approved; Registrations in Progress Macau, Hong Kong, Singapore and China Azurity
Ferabright Brain MRI (tumor imaging) Macau Approved; Registrations in Progress Macau, Hong Kong, Singapore and China Azurity
Cell Therapies
Omisirge Hematologic malignancies, severe aplastic anemia Multiple Registrations in Progress 15 markets across Greater China and SE Asia Ayrmid

Selected Additional Registrations

In addition to the commercial products and pipeline above, our local teams have supported numerous pharmaceutical registrations in Macau, including on behalf of third parties. The examples below are selected publicly verifiable registrations and are not a comprehensive list, as certain engagements are subject to confidentiality obligations. Inclusion reflects regulatory activity and does not necessarily indicate current distribution or commercialization rights.

Products Main Indications Stage Result
Dermatology
Anzupgo Moderate to severe chronic hand eczema Approved Macau
Ophthalmology
Xdemvy Demodex blepharitis Approved Macau
Hematology / Oncology
Aphexda Stem cell mobilization in multiple myeloma Approved Macau
Besremi Polycythemia vera Approved Macau
Ensartinib ALK-positive advanced or metastatic non-small cell lung cancer Approved Macau
Anruixi (Zuberitamab) CD20-positive diffuse large B-cell lymphoma Approved Macau
Envafolimab MSI-H/dMMR advanced solid tumors Approved Macau
Cell Therapy
Inaticabtagene Autoleucel Relapsed or refractory B-cell acute lymphoblastic leukemia Approved Macau

Portfolio Highlights

Latropine, a leading product from Taiwan’s Wufu Chemical Pharmaceutical Co., Ltd., has been hailed as a significant breakthrough in myopia treatment for the 21st century. The primary component of Latropine is atropine, which targets M-type receptors located on the ciliary muscle. This interaction inhibits the contraction of the ciliary muscle and suppresses the adjustment reflex, effectively slowing down the progression of myopia in children. The medication received approval from the Taiwan Drug Administration in 2005, followed by the Macau and Hong Kong Drug Administrations in 2018 and 2019, respectively. We and our China affiliates currently hold exclusive distribution rights for the entire Latropine series in Greater China, which includes Mainland China, Hong Kong, and Macau.

Defal is a pioneering medication for Duchenne muscular dystrophy (DMD) that has been introduced in Macau, China. It functions by binding to specific DNA locations within the nucleus, triggering an increase or decrease in transcription. This alters the levels of proteins associated with mediators, which is crucial in treating DMD patients. The Spanish Drug Administration gave its approval for Defal in 2003, followed by the Macau Drug Administration in 2019. We and our China affiliates currently hold the exclusive distribution rights for Defal in Greater China, encompassing Mainland China, Hong Kong, and Macau.

Venosmil is a flavonoid compound that exhibits a potent effect on venous tonality by augmenting venous contractility mediated by the sympathetic nervous system and amplifying calcium sensitivity and contractility. It demonstrates a significant activity on venous smooth muscle. The Spanish Medicines Agency granted marketing authorization for this drug in 2018. We and our China affiliates currently hold exclusive distribution rights for Venosmil within the Greater China region, including Mainland China, Hong Kong, and Macau.

Dynamogen, comprising of Cyproheptadine α-ketoglutarate, is the first globally researched ingredient of its kind. It has the potential to amplify the activity of histaminergic neurons, thereby promoting the synthesis and release of histamine. Histamine, a neurotransmitter, fosters wakefulness in the brain and also possesses properties that enhance appetite and improve nerve vitality. This drug was granted marketing approval by the Spanish Medicines Agency in 2018. Currently, the exclusive agency rights for Dynamogen within the Greater China region, which includes Mainland China, Hong Kong, and Macau, are held by us and our China affiliates.

Regarded as a leading brand in the realm of anti-aging, Placentex has garnered significant admiration, including that of a former Italian president, leading to its epithet, “skin gold caviar”. The primary ingredient in Placentex, PDRN, stands alone globally as a regenerative healing and repair factor. Its role in promoting collagen synthesis and skin metabolism is exceedingly crucial. Currently, Placentex has ascended to star status within the beauty industry, igniting considerable enthusiasm in countries such as South Korea and Japan, among others.

BRIX3000, introduced in 2012, is a gel formulation primarily consisting of Papain. This active ingredient exhibits a chemical action on bacteria and has the ability to alter tissue consistency, thereby minimizing the traumatic impact associated with the removal of infected tissue.

StroVac® Vaccination serves as a preventative and therapeutic measure for recurrent bacterial urinary tract infections, including bladder and kidney inflammation. It functions as a prophylactic vaccine, fostering immunity and offering individualized protection against infectious diseases.

Myopridin is a centrally-acting muscle relaxant that mitigates polysynaptic reflexes via an anticholinergic mechanism. This compound has served as a muscle relaxant for several decades and has been utilized as a standalone therapeutic agent in countries such as Germany and Italy. However, due to regulatory constraints, German products (Myoson direct tablets, Strathmann, Hamburg, Germany) were retracted from the market in January 2016. Based on the findings of a subsequent study, a tablet containing prednisolone (trade name: Myopridin 3 mg tablet, Strathmann, Hamburg, Germany) was re-approved in December 2017 for the management of central and peripheral muscle spasms, torticollis, lower back pain, and systemic muscle pain in adults. In 2020, Myopridin-based pridinol films received regulatory approval for distribution in additional European nations, including the UK, Poland, and Spain.

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