Approvals and Registrations

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Welcome to our approvals page. Here are the latest drugs our Macao team just got market approval from the Macao Drug Regulatory Authority. Additionally, five to six more US drugs are near to be finished. To view the market approval certificates, please visit the blue links below.

 

Products Main Indications Stage Result Partners
Dermatology
Ruxolitinib Cream Atopic dermatitis Approved Macau (tentative) Incyte
Ophthalmic Pipeline
Tyrvaya Dry eye Approved Macau (tentative) Oyster Point Pharma, Inc.
LeTropin 0.01% Single Pack Mydriasis, Cycloplegia Approved Sole Agent in Greater China Wufu Chemical Pharmaceutical Co., Ltd.
LeTropin 0.01% Multi-pack Mydriasis, Cycloplegia Approved Sole Agent in Greater China Wufu Chemical Pharmaceutical Co., Ltd.
LeTropin 0.05% Single Pack Mydriasis, Cycloplegia Approved Sole Agent in Greater China Wufu Chemical Pharmaceutical Co., Ltd.
LeTropin 0.05% Multi-pack Mydriasis, Cycloplegia Approved Sole Agent in Greater China Wufu Chemical Pharmaceutical Co., Ltd.
Rare Disease Pipeline
Defal Oral Liquid DMD muscular dystrophy Approved Sole Agent in Greater China FAES FARMA, S.A.
Defal Tablets DMD muscular dystrophy Approved Sole Agent in Greater China FAES FARMA, S.A.
Efmody For the treatment of congenital adrenal hyperplasia (CAH) Registration Hong Kong and Macau Diumal Europe B.V.
General Surgery Pipeline
Venosmil Capsulas Symptoms such as venous discomfort in the lower extremities Registration Sole Agent in Greater China FAES FARMA, S.A.
Imcivree For adults and obese children over 6 years Registration Hong Kong and Macau Rhythm Pharmaceuticals, Inc.
Gastroenterology Pipeline
Alginos Oral Liquid Relieve pain caused by reflux of stomach acid and bile into the esophagus Approved Hong Kong and Macau Taiwan Toyo Pharmaceutical Industry Co., Ltd.
Alginos Tablet Relieve pain caused by reflux of stomach acid and bile into the esophagus Approved Hong Kong and Macau Taiwan Toyo Pharmaceutical Industry Co., Ltd.
Health Products Pipeline
Dynamogen Oral Solution Anorexia, malnutrition, etc. Registration Sole Agent in Greater China FAES FARMA, S.A.
Potencialtor Anorexia, malnutrition, male sexual dysfunction, etc. Registration Sole Agent in Greater China FAES FARMA, S.A.
Andrology Pipeline
Sentrip Treatment of male sexual dysfunction Approved Hong Kong and Macau C.L Pharm Co. Ltd.
Cosmetology Pipeline
Placentex Accelerate collagen regeneration, deep skin repair Approved Sole Agent in Greater China Mastelli s.r.l.
Dentistry Pipeline
BRIX3000 Caries (cavities) treatment Approved Sole Agent in Greater China Brix Medical Science
Urology Pipeline
Strovac Prevention of recurrent urinary tract infections Approved Sole Agent in Greater China Strathmann GmbH & Co.KG
Booster-Strovac Prevention of recurrent urinary tract infections Approved Sole Agent in Greater China Strathmann GmbH & Co.KG
Neurology Pipeline
Myopridin Treating spasmodic taut muscles Approved Sole Agent in Greater China Strathmann GmbH & Co.KG

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 Macao 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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