2023-06-15 01:23:41
[헬스코리아뉴스 / 이충만] Hanmi Pharmaceutical has opened the door to competition by securing a first generic targeting the US Janssen’s prostate cancer treatment ‘Zytiga’ (ingredient name: abiraterone acetate).
As a result of this paper’s coverage, the Ministry of Food and Drug Safety approved ‘Abiteron Tab’ as a prescription drug (generic) on the 14th. Approved indications are ▲treatment of patients with metastatic castration-resistant (mCRPC) prostate cancer with asymptomatic or mild symptoms ▲treatment of patients with metastatic castration-resistant prostate cancer who have previously received chemotherapy including docetaxel ▲hormone-responsive high-risk metastatic prostate cancer (mHSPC). It is used in combination with androgen deprivation therapy (ADT) for the treatment of newly diagnosed patients.
In February of this year, Hanmi Pharmaceutical received approval from the Ministry of Food and Drug Safety for a clinical trial plan (IND) for ‘Abiteron Tab.’
The clinical trial was a study comparing blood levels of abiraterone following repeated cross-administration of 500mg of ‘Abiteron’ and 500mg of ‘Zytiga’ in an empty stomach in 43 healthy adult males. As a result, the 90% confidence interval of the mean difference was within log 0.8 to log 1.25, proving that they were biologically equivalent.
‘Zytiga’ is an oral medication used to treat patients with metastatic castration-resistant prostate cancer who had previously undergone chemotherapy. The domestic patent expired in 2018, but the news of domestic pharmaceutical companies’ generic challenge was quiet. In the case of anticancer drugs, preference for original drugs is high and development conditions are difficult. As a result, the entry of generics in the field of anticancer drugs is relatively rare.
As a result, ‘Zytiga’ virtually monopolized the prostate cancer treatment market despite the expiration of its patent. This treatment was listed as a second-line treatment in 2018, and sales increased steeply as the coverage was expanded to the first-line treatment in 2021. Last year, Zytiga’s sales reached 20 billion won.
Meanwhile, the Ministry of Food and Drug Safety approved one clinical trial and marketing of 11 drugs on the same day. Below is a list of clinical trials and drug product approvals approved on this day.
▼Clinical trial approval list
|
company |
product name |
Clinical Trial Title |
clinical trial phase |
implementing agency |
|
Pfizer Korea Pharmaceutical |
PF-06838435 |
To evaluate the efficacy and safety of FIX gene transduction using PF-06838435 (rAAV-Spark100-hFIX-Padua) in adult male participants with moderate to severe hemophilia B (FIX:C≤2%) |
Phase 3 |
Gangdong Kyung Hee University Medical School Hospital |
▼ Drug approval list
|
product name |
company name |
Indications |
Permission review type |
|
Diraxsen Tab. |
Choa Pharmaceutical |
Relief of symptoms associated with constipation |
Over-the-counter drugs (standard manufacturing standards) |
|
Sita Single Tab. 100mg (Sitagliptin Hydrochloride) |
CMG Pharmaceutical |
Administered as an adjuvant to diet and exercise therapy to improve blood sugar control in patients with type 2 diabetes |
Prescription drug (generic) |
|
Sita Single Tab. 50mg (Sitagliptin Hydrochloride) |
CMG Pharmaceutical |
Administered as an adjuvant to diet and exercise therapy to improve blood sugar control in patients with type 2 diabetes |
Prescription drug (generic) |
|
Sita Single Tab. 25mg (Sitagliptin Hydrochloride) |
CMG Pharmaceutical |
Administered as an adjuvant to diet and exercise therapy to improve blood sugar control in patients with type 2 diabetes |
Prescription drug (generic) |
|
Pamadoxepin Tab. 3mg (Doxepin Hydrochloride) |
Korea Perm |
Short-term treatment of insomnia with difficulty maintaining sleep |
Prescription drug (generic) |
|
Pamadoxepin Tab. 6mg (Doxepin Hydrochloride) |
Korea Perm |
Short-term treatment of insomnia with difficulty maintaining sleep |
Prescription drug (generic) |
|
Vildaportmet Tab. 50/850mg (Vildagliptin, Metformin Hydrochloride) |
New One Science |
Administered as an adjuvant to diet and exercise to improve blood sugar control in type 2 diabetic patients for whom combined administration of vildagliptin and metformin is appropriate |
Prescription drug (generic) |
|
Vildaportmet Tab. 50/1000mg (Vildagliptin, Metformin Hydrochloride) |
New One Science |
Administered as an adjuvant to diet and exercise to improve blood sugar control in type 2 diabetic patients for whom combined administration of vildagliptin and metformin is appropriate |
Prescription drug (generic) |
|
Abiteron Tablets 500mg (as Abiraterone Acetate (Micronized)) |
Hanmi Pharmaceutical |
Treatment of patients with metastatic castration-resistant prostate cancer |
Prescription drug (generic) |
|
Novacondro 800 Tablets |
Nova M Healthcare |
Supply of vitamins D, B1, B2, B6 |
Over-the-counter drugs (standard manufacturing standards) |
|
Chickil Tab (Diosmin) |
Taegeuk Pharmaceutical |
blood vessel disease treatment |
Over-the-counter drugs (generic) |
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