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ST Nuotai’s Fulvestrant Injection ANDA Receives FDA Approval, Its First Formulation Approved in the U.S

Jiangsu Sinopep-Allsino Biopharmaceutical Co., Ltd. (stock abbreviation: ST Nuotai, 688076) recently received notice from the U.S. Food and Drug Administration (FDA) that the Abbreviated New Drug Application (ANDA) it submitted for fulvestrant injection has been granted marketing approval. Following a full technical review of the application, the FDA determined that the company’s product is bioequivalent and therapeutically equivalent to the reference listed drug. The ANDA number is 216722. The product is an injectable formulation with a strength of 250 mg/5 mL (50 mg/mL). The approved indication is for estrogen receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women (including natural and artificial menopause) with disease recurrence during or after anti-estrogen adjuvant therapy or progression during anti-estrogen therapy; and in combination with abemaciclib for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in patients whose disease progressed following prior endocrine therapy. Fulvestrant ...
- Source: drugdu
- 39
- November 3, 2026
Another Step in Completing the Bone Metabolism Injection Puzzle

On October 29, 2026, Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. (603707.SH) received an ANDA approval letter (ANDA No.: 216996) from the U.S. Food and Drug Administration (FDA) for its salmon calcitonin injection, officially approving the product for marketing in the U.S. market. This marks another significant step in Jianyou’s international expansion of sterile injectable drugs and signifies the continued expansion of the company’s product portfolio targeting the high-end markets of Europe and the United States. What is salmon calcitonin injection ? Salmon calcitonin is a peptide hormone with an activity approximately 40–50 times stronger than human calcitonin. It inhibits osteoclast activity, reduces bone resorption, and regulates renal excretion of calcium and phosphorus. Its injection is mainly used clinically for: Symptomatic osteitis deformans (Paget’s disease): relieves bone pain and improves bone metabolism disorders; Hypercalcemia: Used for early intervention in critical hypercalcemia; Postmenopausal osteoporosis: For postmenopausal women who are not suitable for ...
- Source: drugdu
- 39
- November 3, 2026
A blockbuster new flu drug developed by Simcere Pharmaceutical failed to go public!

On October 28, according to the official website of the National Medical Products Administration, the Class 1 anti-influenza innovative drug, Madenoxavir tablets, jointly developed by Jiaxing Andicon Biotechnology and Simcere Pharmaceutical , received a drug notification notice that it had failed to be approved for marketing. Screenshot source: NMPA official website Madenoxavir is one of the most promising innovative anti-influenza drugs in China. Originally developed independently by Antcon Biotech, in October 2023, Simcere Pharmaceutical Group entered into an exclusive collaboration with Antcon, acquiring exclusive commercialization rights for its influenza indication in China. The failure to successfully advance its market application has once again brought this domestically produced anti-influenza drug, which was once highly anticipated, into the spotlight. The course of treatment for madenoxavir is short, requiring a single oral dose of one tablet. Madenoxavir is an innovative anti-influenza drug with global independent intellectual property rights. It belongs to the Cap-dependent ...
- Source: drugdu
- 34
- November 3, 2026
A new hepatitis B drug has terminated its clinical trials.

Recently, the U.S. FDA approved GSK’s new drug application for Hibsago (bepirovirsen), a new drug for chronic hepatitis B. This is the world’s first approved antisense oligonucleotide (ASO) drug for chronic hepatitis B. updated the status of its Phase 1 clinical trial for another hepatitis B candidate, GSK3965193 , to ” terminated ,” citing “strategic decision” as the reason. The U.S. Clinical Trials Registry also marked the project as terminated. One pipeline reached market approval, while another drug candidate abruptly halted its first human trial. What kind of R&D choices does GSK make in the hepatitis B drug race? The experiment was terminated. According to publicly available information in the clinical trial registry, this study, numbered NCT05330455 , is a phase I/IIa, multipart, randomized, double-blind, placebo-controlled first-in-human trial (FTIH) that was initiated on April 14, 2022, and enrolled 74 participants at 14 centers in 6 countries around the world. The ...
- Source: drugdu
- 33
- November 3, 2026
Tebo Biotech’s 10mg formulation receives approval, intensifying competition in the long-acting growth hormone market

Recently, Tebo Bio’s independently developed Yipei Growth Hormone Injection (trade name: Yipeisheng) 10mg specification was officially approved for marketing by the National Medical Products Administration. This is another expansion of Yipeisheng’s product portfolio, following the availability of four specifications: 2.5mg, 3.0mg, 3.5mg, and 5.0mg. On the surface, this might seem like just a routine specification update. But for long-acting growth hormone, going from 5mg to 10mg is not simply adding another line to the instructions. In recent years, with the approval of several long-acting growth hormones, “once-a-week” dosing is no longer a label exclusive to any one company. As “long-acting” gradually becomes the industry standard, the focus of competition is quietly shifting downwards—clinical evidence, dosage accuracy, specification compatibility, and the underlying formulation technology barriers. The approval of the 10mg specification has brought this change to the forefront. From 5mg to 10mg To understand the value of 10mg, we need to ...
- Source: drugdu
- 33
- November 3, 2026
CSPC Reports Positive Phase III Results for Prusogliptin Combination Therapy in Type 2 Diabetes

Southern Finance reported on November 2 that CSPC Pharmaceutical Group (01093.HK) disclosed positive topline results in a voluntary announcement for a phase III trial of its prusogliptin tablets combined with dapagliflozin and metformin in patients with type 2 diabetes. The primary endpoint was the change in glycated hemoglobin (HbA1c) from baseline at week 24. The triple regimen produced a significantly greater reduction than the two-drug regimen. Safety was favorable, with a comparable overall incidence of adverse events and no increase in safety risk reported. Source: URL: https://finance.eastmoney.com/a/202611023918878276.html
- Source: drugdu
- 33
- November 3, 2026
Fangsheng Pharmaceutical Receives Clinical Trial Approval for Shuangzao Anshen Granules

Fangsheng Pharmaceutical (603998) announced on November 2 that its internally developed innovative traditional Chinese medicine, Shuangzao Anshen Granules, received clinical trial approval from China’s National Medical Products Administration on October 30, 2026. The proposed indication is chronic insomnia with liver–kidney yin deficiency syndrome. Cumulative R&D spending was approximately RMB 4.61 million at disclosure, on an unaudited basis. The product has not been marketed in China or overseas. Citing the 2025 China Sleep Health Survey Report, the news article states that 48.5% of Chinese adults experience sleep problems, with a higher rate among women. For the first nine months of 2026, the company reported revenue of RMB 1.384 billion and net profit attributable to shareholders of the parent of RMB 289 million. Source: URL: https://finance.eastmoney.com/a/202611023918868557.html
- Source: drugdu
- 29
- November 3, 2026
HEALTH EXPO IRAQ

Organiser：Informa Time：October 28th – 31th, 2026 Address：Baghdad, Iraq Exhibition hall：Baghdad International Fairground Product range: Medical Equipment: Diagnostic equipment, operating room instruments, first aid and rescue equipment, biological medical manufacturing and control equipment, laboratory instruments and equipment, new technologies and equipment, equipment required by hospitals and sanatoriums Medical Products: Hospital surgical medical supplies, modern information technology for health security services About HEALTH EXPO IRAQ： HEALTH EXPO IRAQ is a large-scale and representative international hospital medical equipment technology exhibition in Iraq. Nearly 225 companies from more than 10 countries including Australia, India, Turkey, Thailand and China participated in HEALTH EXPO IRAQ. The organizer of this exhibition has received support from nearly 10 local government and private hospitals, and has successfully introduced the exhibitors’ products to local private hospitals. Iraq is located in the southwestern part of Asia and the northeastern part of the Arabian Peninsula, with an area of about ...
- Source: drugdu
- 31
- November 3, 2026
Wolwo Pharma’s S01D Tablet Approved for Clinical Trials, a New-Mechanism Drug for Drug-Resistant Pulmonary Tuberculosis

Zhejiang Wolwo Biotech Co., Ltd. (Wolwo Pharma) recently downloaded a Clinical Trial Approval Notice from the government service portal of the National Medical Products Administration (NMPA), granting approval for the clinical trial application of its self-developed S01D tablet to conduct trials for the treatment of adult drug-resistant pulmonary tuberculosis. According to the announcement, S01D tablet is classified as a Class 1 chemical drug in tablet form with anti-Mycobacterium tuberculosis activity, intended for adult patients with drug-resistant pulmonary tuberculosis. As of the announcement date, no identical chemical drug has been approved in China or abroad. Tuberculosis treatment currently relies mainly on multidrug combination regimens, while drug-resistant tuberculosis has long faced the clinical challenges of lengthy treatment courses, poor efficacy and severe adverse reactions. As a new molecular entity with a novel mechanism of action, S01D showed superior anti-tuberculosis activity in nonclinical studies. The company is a biopharmaceutical enterprise specializing in the ...
- Source: drugdu
- 72
- November 2, 2026
Two specifications of dexketoprofen tromethamine tablets from Keruide Pharmaceuticals have been approved

Recently, Sichuan Keruide Pharmaceutical Co., Ltd. received a Drug Registration Certificate issued by the National Medical Products Administration, approving the registration of the company’s dexketoprofen tromethamine tablets (25mg and 12.5mg specifications). For patients, this means that in common mild to moderate pain scenarios such as musculoskeletal pain, dysmenorrhea, toothache, and arthritis-related pain, there is an additional option for prescription drugs and room for adjustment of dosage in clinical practice. For Keruide, this further completes its pain management product line. Dexketoprofen can be used in conjunction with the already marketed Keruide (tizanidin hydrochloride) to address pain accompanied by muscle spasms from both peripheral anti-inflammatory and central muscle relaxation perspectives, providing orthopedic, rehabilitation, and pain management doctors with a more comprehensive medication combination. I. What are the approved drugs mainly used to treat? Dextrokeprofen tromethamine tablets are primarily used for the symptomatic treatment of mild to moderate pain caused by various etiologies, ...
- Source: drugdu
- 54
- November 2, 2026

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