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FDA Approves Tryptyr Eye Drops for Dry Eye Disease

By Stephanie Brown HealthDay ReporterMONDAY, June 2, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved the first-in-class TRPM8 receptor agonist Tryptyr (acoltremon ophthalmic solution) for the treatment of signs and symptoms of dry eye disease. Currently, dry eye disease treatment options are limited due to slow therapeutic onset, patient dissatisfaction, and poor adherence. Tryptyr works by stimulating corneal sensory nerves to rapidly increase natural tear production. The ophthalmic solution will be available in single-dose vials with a recommended dosage of one drop in each eye twice a day. Approval of Tryptyr was based on the results of two phase 3 clinical trials (COMET-2 and COMET-3). More than 930 patients with a history of dry eye disease were randomly assigned (1:1) to Tryptyr or vehicle. As early as day 1, Tryptyr delivered statistically significant natural tear production. Patients taking Tryptyr (versus vehicle) experienced a ≥10-mm increase in ...
- Source: drugdu
- 43
- June 3, 2025
Alphamab Oncology Presents New Progress in Clinical Research of JSKN003

June 3, Alphamab Oncology Pharmaceuticals (09966) announced that it recently presented the latest research results of JSKN003 at the 2025 ASCO Annual Meeting. The study conducted a summary analysis of the efficacy and safety of multiple indications, mainly including a Phase I clinical study in patients with advanced/metastatic solid tumors, involving different doses of JSKN003. As of February 28, 2025, a total of 46 PROC patients participated in the study. Among them, 91.3% of patients had tumor shrinkage, the objective response rate (ORR) was 63.0%, the median progression-free survival (mPFS) was 7.7 months, and the 9-month overall survival rate (OS) was 89.9%. In HER2 IHC 0 patients, the ORR was 52.4%, and in HER2 IHC 1+, 2+, and 3+ patients, the ORR was 72.2%. In terms of safety, 19.6% of patients experienced grade 3 or 4 treatment-related adverse events (TRAEs), but no deaths caused by TRAEs occurred. In addition, the ...
- Source: drugdu
- 44
- June 3, 2025
Application for marketing authorization of ranibizumab injection accepted

Huadong Medicine(000963) announced on June 3 that the marketing authorization application for ranibizumab injection (R&D code HJY28) submitted by the company’s wholly-owned subsidiary Hangzhou Sino-US East China Pharmaceutical Co., Ltd. was accepted. Ranibizumab injection is indicated in adults for the treatment of wet (neovascular) age-related macular degeneration (AMD), the treatment of visual impairment caused by diabetic macular edema (DME), the treatment of diabetic retinopathy (DR) [proliferative diabetic retinopathy (PDR) and moderate to severe non-proliferative diabetic retinopathy (NPDR)], the treatment of visual impairment caused by macular edema secondary to retinal vein occlusion (RVO) (branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)), and the treatment of visual impairment caused by choroidal neovascularization (CNV, i.e. CNV secondary to pathological myopia (PM) and other causes). Ranibizumab injection is indicated for premature infants for the treatment of retinopathy of prematurity (ROP) in zone I (stage 1+, 2+, 3 or 3+), zone II ...
- Source: drugdu
- 45
- June 3, 2025
Insomnia creates a multi-billion dollar market

Recently, Lemborexant, a dual orexin receptor antagonist originally developed by Eisai, was approved for marketing by the National Medical Products Administration, marking the official entry of China’s insomnia treatment field into the “dual orexin antagonist era.” Global sales exceeded 2.6 billion yuan Unlike traditional sedative hypnotic drugs, Lebrexan competitively binds to orexin type 1 receptor (OX1R) and type 2 receptor (OX2R), precisely inhibiting orexin-mediated wakefulness drive, thereby inducing natural sleep. In addition, unlike traditional GABA-A hypnotic drugs that inhibit rapid eye movement sleep (REM), Lebrexan can simultaneously extend the duration of non-rapid eye movement sleep (NREM) and REM, optimizing sleep structure to make it closer to the physiological sleep state. Clinical trials have shown that Lebrexan has a mild effect on patients’ memory and cognitive function, and does not significantly interfere with daytime activities (especially driving and other behaviors that require mental concentration). Studies have shown that the drug has ...
- Source: drugdu
- 42
- June 3, 2025
China leads the world in developing the fourth druggable immune checkpoint drug

The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting is in full swing, and the original innovative drug LBL-024 from China has once again become the focus. The drug is a 4-1BB/PD-L1 bispecific antibody that is expected to fill the gap in the clinical treatment of extrapulmonary neuroendocrine carcinoma (EP-NEC). At the same time, positive efficacy signals have been observed in multiple cancer types such as small cell lung cancer and biliary tract cancer. It is worth noting that LBL-024 has entered the critical clinical trial stage. If approved, it will become the world’s first 4-1BB target drug, and will also make 4-1BB the world’s fourth druggable immune checkpoint after PD-1/L1, CTLA-4, and LAG3. 01 The world’s first! LBL-024 breaks through again The American Society of Clinical Oncology (ASCO) Annual Meeting is the world’s largest, most academically advanced and most authoritative clinical oncology conference, and the selected oral reports ...
- Source: drugdu
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- June 3, 2025
PHARMCHINA

Organiser: Reedsinopharm (a subsidiary of Sinopharm Group) Time：November 19-21, 2025 address：No. 300 Jiangdong Middle Road, Jianye District, Nanjing City, Jiangsu Province Exhibition hall：Nanjing International Expo Center Product range: Pharmaceuticals: Chemical drugs, traditional Chinese patent medicines, ethnic medicines, OTC drugs, and biological products. Pharmaceutical R&D Supply Chain: R&D services, CRO (Contract Research Organization), CMO (Contract Manufacturing Organization), CDMO (Contract Development and Manufacturing Organization), MAH (Marketing Authorization Holder) cooperation, and registration consulting. Chinese Herbal Medicine/Chinese Herbal Decoction Pieces: Bulk decoction pieces, traditional decoction pieces, refined packaged decoction pieces, small-package decoction pieces, directly ingestible solid decoction pieces, broken-wall decoction pieces, medicinal and edible Chinese herbal materials and herbal teas, Chinese herbal formula granules, novel Chinese herbal decoction pieces, production equipment for Chinese herbal materials and decoction pieces, packaging for Chinese herbal decoction pieces, etc. Traditional Chinese Medicine (TCM) Health Preservation: Moxibustion and moxibustion products, TCM health preservation centers, foot bath and foot ...
- Source: drugdu
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- June 3, 2025
【EXPERT Q&A】How should accelerated tests be carried out in drug stability studies?

Drugdu.com expert’s response: Accelerated testing is a crucial method for assessing the stability changes of pharmaceuticals under short-term high-temperature and high-humidity conditions. It helps predict stability trends under long-term storage conditions and provides a basis for determining the shelf life and storage conditions of drugs. Below are the detailed steps and key points for conducting accelerated testing: I. Purpose of the Test The primary objective of accelerated testing is to accelerate the degradation or deterioration process of drugs within a relatively short period by elevating storage temperature and humidity conditions, thereby evaluating the stability of the drugs. II. Test Conditions Temperature: Typically, 40℃±2℃ is selected as the temperature condition for accelerated testing. This temperature, higher than the routine storage temperature, can expedite the degradation reactions of drugs. Humidity: The relative humidity is usually set at 75%±5%. High humidity conditions are beneficial for assessing the sensitivity of drugs to moisture. III. ...
- Source: drugdu
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- June 2, 2025
Genor Biopharma’s new drug Leroxili approved for marketing

On May 29, GENOR Bio (06998) issued an announcement that the China National Medical Products Administration has approved the new drug application for Leloxili (GB491). Leroxili (GB491) is a novel, highly potent and selective oral cyclin-dependent kinase 4 and 6 inhibitor co-developed with G1 Therapeutics Inc., designed to improve the treatment of patients with advanced breast cancer. The drug is indicated for adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer, and can be used in combination with aromatase inhibitors as initial endocrine therapy, or in combination with fulvestrant for patients whose disease has progressed after previous endocrine therapy. https://finance.eastmoney.com/a/202505293417987240.html
- Source: drugdu
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- June 2, 2025
Agristim α for injection approved for marketing

On May 29, Mywell Biopharmaceuticals (688062) announced that the marketing application for Agrastim α for injection submitted by its wholly-owned subsidiary Jiangsu Taikang Biotechnology Co., Ltd. was approved by the National Medical Products Administration. The drug is suitable for adult patients with non-myeloid malignancies who are receiving myelosuppressive anticancer drugs that are prone to cause febrile neutropenia. The drug　　can be used to reduce the incidence of infections manifested by febrile neutropenia.The marketed product is also the first domestically marketed G-CSF drug developed using long-acting albumin fusion technology. In the first quarter of 2025, Mabwell Biopharmaceuticals achieved revenue of 44.79 million yuan and a net profit attributable to shareholders of the parent company of -292 million yuan. https://finance.eastmoney.com/a/202505293418060776.html
- Source: drugdu
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- June 2, 2025
Lidocaine and Prilocaine Aerosol Approved for Clinical Trials

On May 29, Fuyuan Pharmaceutical(601089) issued an announcement that its wholly-owned subsidiary Fuyuan Pharmaceutical Co., Ltd. received the “Drug Clinical Trial Approval Notice” for Lidocaine Prilocaine Aerosol approved and issued by the State Drug Administration. Lidocaine Prilocaine Aerosol meets the relevant requirements for drug registration and is approved for clinical trials. Fuyuan Pharmaceutical Co., Ltd. has applied for clinical trials for lidocaine prilocaine aerosol, which is suitable for the treatment of primary premature ejaculation in adult men. The route of administration is local, and the registration classification is chemical drug class 3. So far, Fuyuan Pharmaceutical has invested approximately RMB 9.5477 million in the research and development of this product. In the first quarter of 2025, Fuyuan Pharmaceutical achieved revenue of 830 million yuan and net profit attributable to shareholders of the parent company of 131 million yuan. https://finance.eastmoney.com/a/202505293418053486.html
- Source: drugdu
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- June 2, 2025

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