On April 24, China Resources Double Crane(600062) announced that its wholly-owned subsidiary Hainan Shuanghe recently obtained the drug registration certificate for tigecycline for injection issued by the State Food and Drug Administration. The drug is registered as a Class 4 chemical drug, with a specification of 50 mg and an approval number of National Medicine Standard H20253927. Hainan Shuanghe started the research and development of generic drugs for this drug in December 2021, submitted a marketing authorization application to the National Medical Products Administration on September 20, 2023, and was approved for marketing on April 15, 2025. The announcement mentioned that the cumulative investment in the research and development of this drug was 10.27 million yuan (unaudited). According to market data, the global sales of injectable tigecycline in 2023 were US$218 million, and the total sales in the Chinese market were RMB 848 million. The announcement pointed out that the ...
Drugdu.com expert’s response: Regorafenib tablets are multi-target tyrosine kinase inhibitors primarily used in the treatment of various solid tumors. They possess anti-angiogenic properties and can inhibit tumor cell proliferation and metastasis. Their specific efficacy includes: I. Treatment of Gastrointestinal Stromal Tumors (GIST) Patient Population: Patients with locally advanced, unresectable, or metastatic gastrointestinal stromal tumors who have experienced disease progression or intolerance after previous treatment with imatinib mesylate and sunitinib malate. Mechanism of Action: By inhibiting targets such as KIT, PDGFRα, RET, and VEGFR, it blocks signal transduction pathways in tumor cells, inhibiting tumor growth and angiogenesis. II. Treatment of Hepatocellular Carcinoma (HCC) Patient Population: Patients with hepatocellular carcinoma who have previously received sorafenib treatment. Mechanism of Action: Inhibits targets such as VEGFR, TIE2, PDGFR, and FGFR, reducing tumor angiogenesis and inhibiting tumor growth and spread. III. Treatment of Metastatic Colorectal Cancer (mCRC) Patient Population: Patients with metastatic colorectal cancer who ...
On April 24th, Ruikang Pharmaceutical (002589) released its 2024 annual report. The report shows that the company’s operating revenue in 2024 was 7.966 billion yuan, a year-on-year decrease of 0.85%; The net profit attributable to the parent company was 20.6216 million yuan, a year-on-year increase of 1.50%; The net profit after deducting non attributable expenses was -128 million yuan, a year-on-year increase of 38.84%. It is worth noting that Ruikang Pharmaceutical has been losing non recurring net profit for four consecutive years, and its operating income has been declining for five consecutive years. From 2019 to 2023, the company’s operating revenue was 35.259 billion yuan, 27.204 billion yuan, 21.06 billion yuan, 12.311 billion yuan, and 8.034 billion yuan, respectively; The net profits were -928 million yuan, 260 million yuan, 130 million yuan, -183 million yuan, and 20 million yuan respectively; The net profit after deducting non recurring expenses is ...
On the evening of April 23rd, Liaoning Chengda Biotechnology Co., Ltd. (hereinafter referred to as “Chengda Biotechnology” or “the Company”, stock code: 688739. SH), the leader in rabies vaccines, released its 2024 annual report. In 2024, the company achieved a revenue of 1.676 billion yuan, a net profit attributable to shareholders of 343 million yuan, and a net profit not attributable to shareholders of 324 million yuan. Chengda Biotech is a biopharmaceutical company specializing in the research, development, production, and sales of human vaccines. Its main products include human rabies vaccines and inactivated Japanese encephalitis vaccines. Since 2008, the company’s human rabies vaccines have been the leading market in China, and its inactivated Japanese encephalitis vaccines are the only ones available for sale in the domestic market. The company has a rich and diverse pipeline of products under development, including human diploid rabies vaccines, quadrivalent/trivalent/high-dose influenza vaccines, 15 valent ...
On the evening of April 23, Kangle Guardian (833575) issued an announcement stating that the company’s holding subsidiary Kangle Guardian (Kunming) Biotechnology Co., Ltd. received the “Acceptance Notice” issued by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration. The company’s independently developed recombinant trivalent human papillomavirus (16/18/58) vaccine (Escherichia coli) (hereinafter referred to as “trivalent HPV vaccine”) has been accepted by CDE for marketing authorization. Kangle Guardian said that the trivalent HPV vaccine is the company’s first vaccine to submit a marketing authorization application. If it is successfully approved for listing, it will become the company’s first commercial product. https://finance.eastmoney.com/a/202504233386109657.html
According to the news, on April 23, Gan & Lee Pharmaceuticals announced that the localization project of the company’s core component of insulin products, the bromobutyl rubber piston of the cartridge bottle, has successfully passed the review of the National Center for Drug Evaluation (CDE) and activated the conversion to A, and can be officially used for the packaging and production of insulin products. This move marks that China’s insulin industry chain has achieved independent control in the field of key materials. As the first insulin company in China to realize the localization of this key material, Gan & Lee Pharmaceuticals has injected strong momentum into improving the safety of the drug supply chain and optimizing production costs.
Sichuan Kelun Biotech recently announced that it has obtained approval from the U.S. FDA for its new drug clinical trial (IND) application to initiate clinical research on SKB518, a potential first-in-class ADC drug. According to a press release from Kelun Biotech, SKB518 is an antibody-drug conjugate (ADC) targeting protein tyrosine kinase 7 (PTK7) developed using Kelun Biotech’s OptiDCTM platform technology based on the biological characteristics of the target. It has shown good efficacy and safety window in preclinical trials and is intended to be used to treat advanced solid tumors. Previously, in June 2024, the drug had obtained IND approval from NMPA for advanced solid tumors. The clinical approval in both China and the United States indicates that the global synchronous development strategy of SKB518 is progressing steadily. Protein tyrosine kinase 7 (PTK7) is a Wnt coreceptor that is expressed at low levels in normal epithelial, endothelial, and hematopoietic tissues, ...
On April 20, Changchun High-Tech (000661.SZ) simultaneously released its 2024 annual report and 2025 first quarter report. In 2024, the company achieved operating income of 13.466 billion yuan, a year-on-year decrease of 7.55%; and achieved a net profit attributable to the parent of 2.583 billion yuan, a year-on-year decrease of 43.01%. In terms of a single quarter, in the fourth quarter of last year, Changchun High-Tech suffered a loss, with operating income of 3.08 billion yuan, a year-on-year decrease of 20.8%; net profit attributable to the parent company was a loss of 206 million yuan, a year-on-year decrease of 122.4%; in the first quarter of this year, although it remained profitable, it continued the “double decline” of last year, with a single-quarter income of 2.997 billion yuan, a year-on-year decrease of 5.66%; net profit attributable to the parent company was 473 million yuan, a year-on-year decrease of 44.95%. Changchun High-Tech ...
On April 22, China Resources Double Crane(600062) announced that its wholly-owned subsidiary China Resources Double Crane Limin Pharmaceutical (Jinan) Co., Ltd. recently received a VitaminB6 Injection “Notice of Approval of Drug Supplementary Application”. The drug has passed the generic drug quality and efficacy consistency evaluation, and has added a supplementary application for the 1ml:100mg specification. The approval of this consistency evaluation will be beneficial to the company’s market sales and competitiveness. As of the announcement date, Shuanghe Limin has invested 3.89 million yuan in the consistency evaluation of the drug. According to market data, the global sales of vitamin B6 injection will be 47.17 million US dollars in 2023, of which the total sales in the Chinese market will be 453 million yuan. In 2024, China Resources Double-Crane achieved revenue of 11.212 billion yuan and net profit attributable to shareholders of the parent company of 1.628 billion yuan. https://finance.eastmoney.com/a/202504223384473457.html
April 22, Weixinkang(603676) issued an announcement that recently, the company’s wholly-owned subsidiary Baiyi Pharmaceutical received the “Notice of Approval of Drug Supplementary Application” for potassium magnesium aspartate injection approved and issued by the National Medical Products Administration. The drug successfully passed the generic drug quality and efficacy consistency evaluation. Potassium magnesium aspartate injection is an electrolyte supplement used for the auxiliary treatment of hypokalemia, arrhythmias (mainly ventricular arrhythmias) caused by digitalis poisoning, and sequelae of myocarditis, congestive heart failure, and myocardial infarction. As of the end of March 2025, the company’s cumulative investment in research and development of this drug was RMB 2.0615 million (unaudited). In the first three quarters of 2024, Weixinkang achieved revenue of 994 million yuan and net profit attributable to shareholders of the parent company of 243 million yuan. https://finance.eastmoney.com/a/202504223384343433.html
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