PharmaFocus Today – media

FDA Approves Lerochol for Adults with Elevated LDL Cholesterol

FDA has announced the approval of LIB Therapeutics’ Lerochol (lerodalcibep-liga) for subcutaneous (SC) use as an adjunct to diet and exercise in reducing low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Lerochol is a small protein-binding, third-generation PCSK9 inhibitor. The drug was developed as a once-monthly, single small-volume, SC injection with extended room temperature stability up to three months, making Lerochol a more convenient alternative to other PCSK9 inhibitors.1 The anti-PCSK9 binding domain of Lerochol is an 11-kDa polypeptide called adnectin, which was developed for high-affinity subnanomolar binding to human PCSK9 and fused to human serum albumin to improve plasma half-life. “While PCSK9 inhibitors as a class deliver powerful cholesterol lowering potential, Lerochol was designed to address the barriers that have limited their use, including ease of use features like a single small monthly injection, self-administered at home with extended room-temperature stability for home storage ...
- Source: drugdu
- 34
- December 16, 2025
How to Head Off Tendon Trouble

By Carole Tanzer Miller HealthDay ReporterSUNDAY, Dec. 14, 2025 (HealthDay News) — Injure a tendon and you might not notice right away, but beware: These injuries often fail to heal properly, putting everyday activities at risk. “No matter how strong your muscle is, you’re not going to be able to have the functionality and the stability you need if a tendon is impaired,” Nelly Andarawis-Puri, a bioengineering researcher at Cornell University in Ithaca, N.Y., told NIH News in Health. Tendons connect your muscles and your bones. Your ability to move your body is at risk when tendon tissue becomes inflamed, ruptures or breaks down. You might experience pain or stiffness, swelling and weakness. A sudden awkward movement is sometimes to blame — but everyday activities that require repetitive movements pose particular risks. (Think: Typing long hours at the office, which may make your hands hurt, or doing repeated jumping exercises ...
- Source: drugdu
- 34
- December 16, 2025
Ascletis Pharma’s ASC50 Phase I clinical trial in the United States yielded positive topline results

On December 15, Ascletis Pharma-B (01672) announced positive top-line results from its independently developed oral small molecule IL-17 inhibitor, ASC50, in a Phase I clinical trial in the United States. The primary objective of the trial was to evaluate the safety, tolerability, and pharmacokinetic characteristics of ASC50. Forty-six healthy subjects received different doses of ASC50 (10 mg to 600 mg). The results showed that the elimination half-lives of ASC50 at each dose were 43, 89, 91, 87, 104, and 85 hours, supporting once-daily or potentially weekly oral administration. Furthermore, ASC50 demonstrated significant targeted binding efficacy after administration, with IL-17A levels remaining elevated up to day 7 at higher doses. Safety and tolerability were good at all dose levels, with all adverse events being mild and no serious adverse events reported. Based on these positive results, ASC50 will advance to the next phase of clinical development, conducting multi-dose escalation studies for ...
- Source: drugdu
- 29
- December 16, 2025
Hualan Biological’s application for clinical trial of pembrolizumab injection has been accepted

Hualan BiologicalOn December 16, the company announced at noon that its investee company, Hualan Gene Engineering Co., Ltd., received the “Acceptance Notice” from the National Medical Products Administration for its application for clinical trial registration of pembrolizumab injection for domestic production. Hualan Biological stated that its pembrolizumab injection is a biosimilar. The original pembrolizumab product (trade name: Keytruda®) is manufactured by Merck.The company developed one of the world’s first approved PD-1 inhibitors, which has been approved globally for dozens of important oncology indications, including non-small cell lung cancer, melanoma, head and neck squamous cell carcinoma, esophageal cancer, liver cancer, gastric cancer, and colorectal cancer. Its clinical value has been widely recognized. https://finance.eastmoney.com/a/202512163592877572.html
- Source: drugdu
- 29
- December 16, 2025
Another Phase 3 clinical trial failed.

Recently, biotechnology company Arcus Biosciences and its partner Gilead announced the formal termination of the Phase III clinical trial STAR-221 , which combines PD-1, TIGIT, and chemotherapy as first-line treatment for gastric cancer , because the study showed no efficacy in the interim analysis . STAR-221 is a global, randomized, open-label phase III clinical trial that enrolled approximately 1040 patients with locally advanced, unresectable, or metastatic HER-2-negative gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. The study aimed to evaluate the efficacy and safety of Arcus’ anti-TIGIT monoclonal antibody domvanalimab in combination with its PD-1 inhibitor zimberelimab and chemotherapy regimens (FOLFOX or CAPOX) as first-line treatment, compared to the standard therapy nivolumab (Opdivo) in combination with chemotherapy. The primary endpoint of the study was to assess overall survival (OS) in tumors with high PD-L1 expression (TAP ≥ 5%), PD-L1-positive tumors (TAP ≥ 1%), and the intention-to-treat population (all PD-L1 levels) ...
- Source: drugdu
- 29
- December 16, 2025
Ascletis Investors surges fourfold! A quiet turnaround for Ascletis!

Recently, Ascletis Pharma released Phase II study data for its oral small molecule GLP-1 drug ASC30. In 125 obese or overweight subjects, the 60 mg dose group experienced a weight loss of up to 7.7%, and no weight loss plateau was observed. Following the announcement, Ascletis Pharma’s stock price surged by more than 20% intraday on December 9. In fact, Ascletis Pharma’s stock price has increased approximately fourfold this year, ranking among the top performers in the pharmaceutical industry. 01 The data is amazing. small molecule GLP-1R completely biased agonist developed by Ascletis Pharma . According to publicly available information from Ascletis Pharma, this drug possesses unique and differentiated properties, and can be taken orally once daily or subcutaneously once monthly to quarterly as a treatment or maintenance therapy for long-term weight management. Furthermore, it is not subject to dietary restrictions and can be taken at any time of day. ...
- Source: drugdu
- 29
- December 16, 2025
Fosun Pharma Receives Regulatory Inquiry Letter from SSE Over Planned Controlling Stake Acquisition of Green Valley Pharmaceutical

On December 16, the Shanghai Stock Exchange (SSE) issued a regulatory inquiry letter to Fosun Pharma regarding its external investment in Green Valley Pharmaceutical, addressing matters related to the listed company. On December 15, Fosun Pharma announced that its controlling subsidiary, Fosun Pharma Industrial, had entered into a relevant investment agreement with Green Valley (Shanghai) Pharmaceutical Technology Co., Ltd. (“Green Valley Pharmaceutical”) and its existing shareholders. The agreement involves an investment of approximately RMB 1.412 billion to acquire a controlling stake in Green Valley Pharmaceutical. Upon completion of the acquisition, Green Valley Pharmaceutical will become a controlling subsidiary of Fosun Pharma, and its core drug, Sodium Oligomannate Capsules, will be integrated into Fosun Pharma’s innovative drug pipeline. The drug is primarily indicated for the treatment of mild to moderate Alzheimer’s disease. Reference: https://finance.eastmoney.com/a/202512163592385827.html
- Source: drugdu
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- December 16, 2025
Innovation-Driven Vaccine Upgrades, Focusing on Core Products and Pipeline Development

After fifteen years of deep cultivation in the vaccine field, AB&B Bio Tech has accelerated on the path of differentiated innovation. Listed on the Hong Kong Stock Exchange in August, AB&B Bio Tech has fortified its competitive edge with core products such as its first quadrivalent subunit influenza vaccine covering all age groups from 6 months and above. Its Hong Kong IPO was oversubscribed by over 4,000 times. In a recent exclusive interview with China Securities Journal, An Youcai, Chairman and General Manager of AB&B Bio Tech, comprehensively detailed the company’s product strategy, performance delivery logic, use of raised funds, and future development blueprint. He clarified that with “innovation-driven” as the core, the company aims to achieve a revenue target of RMB 2 billion by 2030 through capacity expansion and international布局, striving to join the top tier of domestic vaccine enterprises. Differentiated Strategy Enhances Product Competitiveness AB&B Bio Tech listed ...
- Source: drugdu
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- December 16, 2025
Huadong Medicine has made a significant leap in international research and development. Its new product has been granted orphan drug status by the FDA

On December 15th, Huadong Medicinel (000963) announced that its independently developed ADC innovative drug, Injection HDM2012, has obtained orphan drug qualification recognition (Orphan Drug Designation, ODD) from the US Food and Drug Administration (referred to as “US FDA”) for two indications: gastric cancer and gastroesophageal junction cancer, as well as pancreatic cancer. This proves that the innovative nature of its ADC research has been internationally recognized. Meanwhile, the innovative multi-peptide-based long-acting agonist HDM1005 injection for dual-targeting human GLP-1 (glucagon-like peptide-1) receptor and GIP receptor (glucose-dependent insulinotropic polypeptide), developed by the wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as “Zhongmei Huadong”), achieved positive results in the Phase II clinical trial for weight management indications in China. These two milestones signify a significant leap forward for Huadong Pharmaceutical in the internationalization and cutting-edge exploration of new drug research. They not only demonstrate the company’s successful implementation of its ...
- Source: drugdu
- 29
- December 16, 2025
Rona Therapeutics Completes First Cohort Dosing in First-in-Human Phase 1 Clinical Trial of Obesity Treatment RN3161

Rona Therapeutics announced on December 15, 2025, that Cohort 1 dosing for their RN3161 drug, a GalNAc-conjugated siRNA targeting INHBE for obesity, had been completed in its Phase 1 clinical trial. Initial data from this cohort indicated good safety and tolerability, reaching a clinical milestone for the company’s INHBE program. Completion of dosing for the remaining cohorts is expected in 2026. https://finance.eastmoney.com/a/202512153592095373.html
- Source: drugdu
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- December 16, 2025

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