Chuang Yi Biotech (CYB) (6566) announces Taiwan Food and Drug Administration (TFDA) has officially approved BELVIQ® (沛麗婷), a new weight-loss drug with new ingredients.2017/07/31
According to Nutrition And Health Survey in Taiwan, the percentage of Taiwan adults with overweight (BMI≧24) is 43%, around 8.1 million. TFDA also suggests the adult obesity (BMI≧27) rate in Taiwan is 21%, around 4 million.
BELVIQ® was developed by Arena Pharmaceuticals, Inc. (Arena), which announced the execution of an exclusive license agreement developing Taiwan market with CYB in July 2013. CYB started to execute Patient Inclusion of Phase 3 Bridge Study in March 2015, and completed unblinding procedures in clinical trials in January 2017. The main efficacy indicator shows no significant difference between easterners and westerners statistically. In July 2017, BELVIQ® was approved by TFDA, becoming the first approved weight-loss drug with new ingredients since 2001. After BELVIQ® is listed in Taiwan, CYB has its exclusive sales rights; and Arena is in charge of manufacturing and supply.
Lorcaserin Hydrochloride (Product Name: BELVIQ®) is a selective serotonin receptor (5-hydroxytryptamine receptor 2C, 5-HT2C) agonist, It can highly specific binding on 5-HT2C receptor, and achieving weight loss by increasing satiety and decreasing food intake.
This product has been listed in the United States and South Korea, and there are more than 7,000 subjects in these clinical trials. According to the primary endpoints of these clinical trials, the results are as follow:
(1) At week 52, more patients receiving lorcaserin lost at least 5% body weight than receiving placebo, and the result has statistical significance: (47.1% vs 22.6% P < 0.001).
(2) At week 52, with an average weight reduction of 6.63 kg in lorcaserin group is statistically significant compared to 2.92 kg in placebo group: (-6.63 VS - 2.92 P < 0.001).
(3) At week 52, more patients receiving lorcaserin lost at least 10% body weight than receiving placebo, and the results has statistical significance: (22.4% vs 8.7% P < 0.001).
Given that rare clinical data among Asians abroad, CYB has executed Bridge Study, required by TFDA, to prove there is no significant difference between eastern and western human races.
According to the primary endpoints of bridge study in Taiwan, the results indicate as follow:
(1) At week 24, more patients receiving lorcaserin lost at least 5% body weight than receiving placebo, and the result has statistical significance: (52.38% VS 28.05% P=0.001).
(2) At week 24, with an average weight reduction of 5.8 kg in lorcaserin group is statistically significant compared to 3.6 kg in placebo group: (-5.8 VS -3.6 P=0.044).
Jacky Wang, Chairman and President, CYB, stated that CYB had dedicated to developing self-pay drugs with high efficacy, including Taiwan New Ingredient Drugs, New Indication Drugs, New Compound Drugs, New Formula Drugs, and OTC Drugs, for many years. Through years of persistence and efforts in this strategic direction, and from the unblinding results of Bridge Study of Lorcaserin Hydrochloride, CYB proves that its goals have been gradually achieved. In the future, CYB will continue to enhance the positioning of our own self-pay medical products through clinical trials and regulatory registration.
Besides announcement about the granted drug license above, all investors should be kindly reminded that there can be no guarantee that the investment objective will be achieved or provide the returns. Investment can involve risk, and thus investors should stay cautious.