Announced details
Treatment of opioid-induced constipation (OIC)
In the Phase 3 trial, the naldemedine group showed a statistically significant increase in the primary endpoint compared with the placebo group. The primary endpoint was the proportion of patients who had at least 3 spontaneous bowel movements per week and an increase of at least 1 bowel movement per week from baseline.
Already marketed in Japan, the United States and Europe, among other markets
塩野義有限公司 is a group company of the Company. The Company will work with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. on the sale and promotion of naldemedine in China.
塩野義有限公司 is a group company of the Company headquartered in Shanghai, China. Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is headquartered in Jiangsu Province, China, and is a core subsidiary of China Biologic Products Holdings, Inc., a Hong Kong-listed company. It conducts pharmaceutical research, development, manufacturing and commercialization on an integrated basis in China, with multiple sites, including in Shanghai, Nanjing and Lianyungang, and more than 7,000 scientific and sales personnel.
China's National Medical Products Administration (NMPA)
塩野義有限公司: Shanghai, China. Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: Jiangsu Province, China, with multiple sites including in Shanghai, Nanjing and Lianyungang.
The impact on consolidated results for the fiscal year ending March 2027 will be minor.
The company does not address Contract Value / Offering price.
American Gastroenterological Association (AGA) guidelines
European Society for Medical Oncology (ESMO) guidelines
Phase 3 clinical trials conducted in China and outside China
| Item | Details |
|---|---|
| Names of Products / Services Covered | Naldemedine Tosilate (naldemedine), Symproic®, Symproic®, Rizmoic® |
| Counterparty | 塩野義有限公司, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Counterparty overview | 塩野義有限公司 is a group company of the Company headquartered in Shanghai, China. Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is headquartered in Jiangsu Province, China, and is a core subsidiary of China Biologic Products Holdings, Inc., a Hong Kong-listed company. It conducts pharmaceutical research, development, manufacturing and commercialization on an integrated basis in China, with multiple sites, including in Shanghai, Nanjing and Lianyungang, and more than 7,000 scientific and sales personnel. |
| Relationship with the Company | 塩野義有限公司 is a group company of the Company. The Company will work with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. on the sale and promotion of naldemedine in China. |
| Applicable area | Treatment of opioid-induced constipation (OIC) |
| Awarding / certifying body | China's National Medical Products Administration (NMPA) |
| Location | 塩野義有限公司: Shanghai, China. Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: Jiangsu Province, China, with multiple sites including in Shanghai, Nanjing and Lianyungang. |
| Location scale | More than 7,000 scientific and sales personnel at Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Quantitative Effects | In the Phase 3 trial, the naldemedine group showed a statistically significant increase in the primary endpoint compared with the placebo group. The primary endpoint was the proportion of patients who had at least 3 spontaneous bowel movements per week and an increase of at least 1 bowel movement per week from baseline. |
| Usage history | Already marketed in Japan, the United States and Europe, among other markets |
| Impact on Business Performance | The impact on consolidated results for the fiscal year ending March 2027 will be minor. |
| Source | American Gastroenterological Association (AGA) guidelines, European Society for Medical Oncology (ESMO) guidelines, Phase 3 clinical trials conducted in China and outside China |
Items this document does not state (6)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Because favorable results were obtained in Phase 3 clinical trials conducted in China and outside China.