今年4月，国家药监局药品审评中心（CDE）官网发布信息显示，常山药业控股子公司常山凯捷健生物申报的艾本那肽注射液（CJC-1134-PC注射液）上市申请获受理，拟用于改善2型糖尿病患者的血糖控制。At today's earnings conference, investors repeatedly inquired about the progress and approval time of GLP-1 variety exenatide injection review, with management stating that it is unpredictable. Management disclosed that the on-site verification and registration inspection of exenatide injection have been completed, but no clinical trials for weight loss indications have been conducted yet. Regarding the declining performance in multiple quarters, management stated that they will accelerate overseas expansion to restore the profitability of the heparin business.
Finance Associated Press, October 15th (by reporter Lu Afeng) - "When will it be approved?" "Is the efficacy better than semaglutide?" "How is the progress of the API review?" At today's afternoon earnings briefing, Hebei Changshan Biochemical Pharmaceutical (300255.SZ), the company that previously attracted high market attention for its GLP-1 variety exenatide injection, faced intensive questioning from investors.
"There are many issues involved in the drug registration process, each with different processing timelines, making it impossible to accurately estimate the final approval result time." "Exenatide API has not yet passed the joint review and approval with formulations." Responding to several similar questions, the Chairman and General Manager of Hebei Changshan Biochemical Pharmaceutical, Gao Xiaodong, and other executives all replied in the above manner.
In April of this year, the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that the market application for the exenatide injection (CJC-1134-PC injection) submitted by Changshan Kaitie Health Bio-technology Co., Ltd., a subsidiary of Hebei Changshan Biochemical Pharmaceutical, has been accepted, intended to improve the blood sugar control of type 2 diabetes patients.
Back in September 2023, before Hebei Changshan Biochemical Pharmaceutical released the Phase III clinical research summary report of the exenatide injection, a GLP-1 variety similar to the currently popular semaglutide and liraglutide, the stock price reached a recent high of 17.98 yuan per share, and the market cap exceeded one billion, making Hebei Changshan Biochemical Pharmaceutical a hot 'GLP-1 concept stock' in investors' eyes.
Faced with conservative responses from management, some investors persistently questioned the progress of the GMP compliance inspection for the exenatide injection revealed in the annual report, as well as the progress in production capacity construction.
This time, Gao Xiaodong gave a clear response, revealing that "the company has cooperated and basically completed the on-site verification work by the China Food and Drug Administration's Center for Food and Drug Inspection and the registration inspection work for exenatide by the China National Institutes for Food and Drug Control."
As a GLP-1 drug, are there any plans to conduct research on weight loss indications? Finance Associated Press reporters and some investors raised such questions.
Gao Xiaodong replied, "The company will consider the subsequent research and development of abenakin peptide based on the approval status of abenakin peptide, its own characteristics, the market situation of other indications, etc. The company has not yet conducted clinical trials of abenakin peptide for obesity or weight loss."
It is worth mentioning that Hebei Changshan Biochemical Pharmaceutical is a leading enterprise in heparin products. The company's nadroparin calcium injection won the eighth batch of national centralized drug procurement. According to its semi-annual report, in the first half of 2024, despite the sales volume of the company's nadroparin calcium injection doubling year-on-year, the sales revenue increased by 16.22% compared to the same period of the previous year, but sales revenue decreased by 14.70% year-on-year due to price impact.
Moreover, in the past, Hebei Changshan Biochemical Pharmaceutical's main product, low molecular weight heparin calcium injection, was not included in the national centralized procurement, only implemented at the provincial level in some regions. Under the policy of drug centralized volume-based procurement, the sales prices of unassessed low molecular weight heparin formulations were restricted, leading to a significant year-on-year decrease in sales volume and revenue of low molecular weight heparin calcium injections in the first half of 2024.
According to its financial data, Hebei Changshan Biochemical Pharmaceutical has seen year-on-year revenue decline for multiple quarters since the first half of 2022.
Regarding how to reverse the decline in performance, Gao Xiaodong expressed to investors, "In recent years, the company's heparin business has been significantly impacted by various factors such as domestic centralized procurement and the decline in the prices of active pharmaceutical ingredients, which has had a major impact on the company's performance. The company is actively striving to restore the profitability of the heparin business by reducing costs, expanding export sales, accelerating international formulation registrations, and other means."
