Securities code: 002262 securities abbreviation: Jiangsu Nhwa Pharmaceutical Co.Ltd(002262) Announcement No.: 2022-001
Jiangsu Nhwa Pharmaceutical Co.Ltd(002262)
About obtaining oxalidine fumarate injection (trv130)
Announcement of notice of acceptance of listing license application
The company and all members of the board of directors guarantee that the contents of the announcement are true, accurate and complete without false records, misleading statements or major omissions.
Jiangsu Nhwa Pharmaceutical Co.Ltd(002262) (hereinafter referred to as "the company") recently received the acceptance notice of the new drug marketing application (NDA) of oxalidine fumarate injection (hereinafter referred to as "trv130") issued by the State Drug Administration. The relevant information is hereby announced as follows:
1、 Main contents of acceptance notice
Applicant: Jiangsu Nhwa Pharmaceutical Co.Ltd(002262)
Product Name: oxalidine fumarate injection
Dosage form: injection
Application item: registration and marketing license of domestically produced drugs
Specification: 1ml: 1mg; 2mL:2mg; 10mL :10mg
Registration category: chemical class 3
Indications: This product is suitable for acute pain of adult patients who need intravenous opioids and poor alternative therapy. Acceptance No.: cyhs2200222; CYHS2200223； CYHS2200224
2、 Drug related information
Trv130 is a first in class novel small molecule G protein developed by Trevena company μ- Opioid receptor (MOR) agonists can preferentially activate the analgesic efficacy signal pathway and reduce the activation of the signal pathway causing adverse reactions. Oselidine fumarate injection (trade name: olinvyk) was approved for marketing in the United States in 2020 to treat moderate to severe acute pain in adult patients who need intravenous opioids. According to the license agreement previously signed between the company and Trevena, the company has the exclusive interest in the development and commercialization of trv130 in Greater China.
The data of Chinese clinical bridging study showed that the safety and pharmacokinetic characteristics of trv130 Chinese patients were consistent with those of global studies, and the safety and tolerability were good in Chinese population; Compared with morphine, trv130 has the same analgesic effect, faster onset and lower incidence of adverse reactions such as nausea and vomiting, which is consistent with the conclusion of overseas clinical trials. These research data show that trv130 has a good benefit / risk ratio in Chinese subjects.
3、 Impact on the company
The company has strong market competitiveness in the field of narcotic drugs. The acceptance of trv130 listing license application reflects the company's technical advantages in this field. According to the requirements of laws and regulations related to drug registration in China, after the application for listing license of trv130 is accepted, it must be reviewed and approved by the State Drug Administration and obtain the production approval before it can be listed for sale.
Trv130 has no significant impact on the company's short-term financial status and operating performance before listing. After trv130 is approved for listing in the future, it will enrich the company's product pipeline in the field of anesthesia, help to improve the company's core competitiveness and have a positive impact on the company's future performance.
4、 Risk tips
Drug R & D has the characteristics of long cycle and large investment, and is affected by uncertain factors such as industrial policies. Whether the drug can be approved, the time of approval, the production and sales after approval, and the impact on the company's performance are uncertain. Please make careful decisions and pay attention to investment risks.
5、 Documents for future reference
Acceptance notice.
It is hereby announced.
Jiangsu Nhwa Pharmaceutical Co.Ltd(002262) board of directors January 27, 2022
