PharmaFocus Today – Page 56 – media

JSKN003 Receives Breakthrough Therapy Designation in China

CSPC Pharmaceutical Group announced that JSKN003 (an antibody-drug conjugate targeting HER2 dual epitopes) developed by its subsidiary Shanghai Jinman Biotechnology Co., Ltd. and Jiangsu Alphamab Biopharmaceuticals Co., Ltd. has been granted Breakthrough Therapy Designation by the China National Medical Products Administration. The proposed indication is monotherapy for the treatment of all patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer (“the indication”). The annual incidence of ovarian cancer ranks third among female reproductive system tumors in China, and the mortality rate ranks first among female reproductive tract malignancies. About 70% of patients are in the advanced stage when they seek medical treatment. Tumor cell reduction surgery combined with postoperative platinum-containing chemotherapy is the current main treatment method, but almost all patients eventually develop platinum resistance. For patients with platinum resistance, non-platinum single-agent chemotherapy is the main treatment option recommended by domestic and international guidelines, but ...
- Source: drugdu
- 160
- March 19, 2025
Shapuaisi obtains drug registration certificate for tafluprost eye drops

On March 17, Shapuaisi (603168) issued an announcement that the company recently obtained the “Drug Registration Certificate” for tafluprost eye drops approved and issued by the State Drug Administration. The drug is an ophthalmic preparation with a specification of 0.0015% (0.3ml: 4.5μg) and is registered as Class 4 chemical drugs. The company’s cumulative R&D investment in the drug is approximately RMB 6.46 million. Obtaining a drug registration certificate will help enrich the company’s product categories and optimize product layout. However, the future production and sales of the drug will still face many uncertain factors such as changes in pharmaceutical industry policies, bidding and procurement, and market environment, so there is uncertainty about the impact on the company’s performance. https://finance.eastmoney.com/a/202503173347698684.html
- Source: drugdu
- 103
- March 19, 2025
Huiyu Pharmaceuticals Obtains Drug Registration Certificate for Melphalan Hydrochloride

On March 17, Huiyu Pharmaceuticals issued an announcement that the company recently received the “Drug Registration Certificate” for Melphalan Hydrochloride for Injection approved and issued by the State Drug Administration. The registration classification of this drug is Class 4 chemical drugs, the specification is 50mg, and the drug validity period is 18 months. The registration certificate number is 2025S00720, and the drug approval number is National Medicine Standard H20253620. Melphalan is suitable for high-dose pretreatment and palliative treatment of patients with multiple myeloma. According to Minnet data, the sales of melphalan hydrochloride for injection in terminal hospitals in urban public hospitals in China in the first half of 2024 were approximately 86 million yuan. The company is the second company deemed to have passed the consistency evaluation of generic drug quality and efficacy. It is expected that drugs that have passed the consistency evaluation will receive greater support in areas ...
- Source: drugdu
- 95
- March 19, 2025
Two drugs were included in the “Rare Disease Drug Development “Care Plan”

Recently, according to the official website of CDE, Hydroxocobalamin Injection of China Resources Double Crane and Fitusiran Injection of Genzyme Corporation were included in the pilot project of the “Patient-centered Rare Disease Drug R&D Pilot Work Plan (“Care Plan”)”. 1. Hydroxocobalamin Injection Variety name: Hydroxocobalamin injection Applicant: China Resources Double Crane Pharmaceutical Co., Ltd. Indications: This drug is suitable for the treatment of metabolic disorders in children with methylmalonic acidemia (MMA) with or without homocystinemia. Application stage: Phase A – R&D project establishment stage. Key points: During the R&D project establishment stage, detailed patient survey questionnaires will be collected to provide a basis for subsequent drug development, dosage forms, etc.; at the same time, the data on the natural history of MMA disease will be further enriched. 2. Fitusiran Injection Product name: Fitusiran injection Applicant: Genzyme Corporation Indications: This product is indicated as a routine preventive treatment for adult patients ...
- Source: drugdu
- 138
- March 19, 2025
First proof, first installment! Two medical devices approved for market launch

Recently, the injectable hydroxyapatite microsphere facial filler (registration certificate number: National Medical Device Approval No. 20253130390) applied by Shanghai Moyang Biotechnology Co., Ltd. has been approved for market by the National Medical Products Administration. At the same time, Merz North America Inc., a subsidiary of Merz North America Inc., which is represented by Merz Business Management Consulting (Shanghai) Co., Ltd., also obtained market approval on March 10, 2025 for the injectable hydroxyapatite microsphere facial filler produced by Merz North America Inc. (Registration number: National Medical Device Injection No. 20253130124). 1st domestically produced product Shanghai Moyang Biotechnology Co., Ltd.’s injectable hydroxyapatite calcium phosphate microsphere facial filler is the first officially approved hydroxyapatite based facial injection filler material in China, suitable for subcutaneous injection in the nasolabial folds to correct moderate to severe nasolabial folds. According to publicly available information, the main components of this product are: calcium hydroxyphosphate, sodium carboxymethyl cellulose, ...
- Source: drugdu
- 113
- March 18, 2025
“Gastrointestinal Endoscopic Surgical Instrument Control Equipment” is approved for market launch

Recently, the National Medical Products Administration approved the registration application for the innovative product “Gastrointestinal Endoscopic Surgical Instrument Control Equipment” of Shenzhen Robb Medical Technology Co., Ltd. (hereinafter referred to as Robb Medical). Fill the domestic gap Founded in 2015, Robb Medical is a medical robot research and development enterprise that has entered the industrialization stage. Since its establishment, it has been committed to the technological research and development of flexible digestive endoscopic surgical robots, and is currently the earliest surgical robot company in the world to enter the industrialization stage in this field. After years of development, Robb Medical has become a hub for technology and talent in the field of medical robotics. It has accumulated certain technologies in the manufacturing of rehabilitation robots, flexible robotic arms, parallel surgical robot design and control, force feedback, machine vision, automatic surgery, and has taken the lead in using these technologies in ...
- Source: drugdu
- 175
- March 18, 2025
Levosalbutamol Hydrochloride Nebulized Inhalation Solution Obtains Drug Registration Certificate

On March 14, Luoxin Pharmaceuticals issued an announcement stating that its subsidiary Luoxin Anruovita Pharmaceuticals (Chengdu) Co., Ltd. received the “Drug Registration Certificate” for Levosalbutamol Hydrochloride Nebulized Inhalation Solution approved and issued by the State Drug Administration. Levosalbutamol is a β2-adrenergic receptor agonist that can relax all airway smooth muscles from the trachea to the terminal bronchioles. Levosalbutamol Hydrochloride Nebulized Inhalation Solution is suitable for the treatment or prevention of bronchospasm caused by reversible airway obstructive diseases in adults and children over 6 years old. The original developer of Levosalbutamol Hydrochloride Nebulized Inhalation Solution was Sepracor Inc. of the United States. It was launched in the United States in 1999 under the trade name: XOPENEX. The original formulation has not yet been imported into China. The company’s salbutamol hydrochloride nebulized inhalation solution has obtained a drug registration certificate according to the new registration classification of chemical drugs, Class 3, and ...
- Source: drugdu
- 124
- March 18, 2025
Obtained the Drug Registration Certificate for Taijilidine Fumarate Injection

On March 16, Hengrui Medicine (600276.SH) announced that the company received the “Drug Registration Certificate” for Taijilidine Fumarate Injection approved and issued by the National Medical Products Administration, approving the company’s independently developed Class 1 innovative drug Taijilidine Fumarate Injection to add new indications and merge and revise the instructions. The indication is for the treatment of moderate to severe postoperative pain. The drug is a μ opioid receptor-biased small molecule agonist, which was approved for marketing in China in January 2024. It is suitable for moderate to severe pain after abdominal surgery and is China’s first independently developed Class 1 opioid analgesic innovative drug. As of now, the cumulative R&D investment in related projects is approximately RMB 197.91 million. https://finance.eastmoney.com/a/202503163346884091.html
- Source: drugdu
- 152
- March 18, 2025
Expected to Significantly Reduce Losses in 2024

AIM Vaccine announced on the Hong Kong Stock Exchange in the morning of March 17 that it expects to significantly reduce losses in performance. It is expected to record unaudited revenue of between 1.25 billion and 1.3 billion during the reporting period, an increase of 60 million to 110 million from the previous year’s revenue of 1.19 billion, an increase of 5% to 9%, and an unaudited net loss of between 250 million and 290 million yuan, a significant reduction of 1.66 billion to 1.7 billion from the previous year’s net loss of 1.95 billion yuan, a reduction of 85% to 87%. The board of directors initially believes that the increase in revenue is mainly due to the increase in the company’s hepatitis B vaccine revenue, and the reduction in comprehensive net losses is mainly due to the reduction in the amount of large asset impairment losses and the increase in ...
- Source: drugdu
- 164
- March 18, 2025
China’s first and the world’s second IGF-1R antibody drug approved for marketing

Good news for patients with thyroid eye disease! Tetuinumab N01 injection (trade name “Synbimin”), the first IGF-1R antibody drug in China and the second in the world developed by Innovent Biologics, was approved for marketing by the National Medical Products Administration (NMPA) on March 14 for the treatment of thyroid eye disease (TED). “The protracted course of thyroid eye disease seriously affects the patient’s visual function and appearance, and can bring a heavy psychological burden to the patient. At present, glucocorticoids are the first choice for the treatment of thyroid eye disease in China, but their efficacy in treating exophthalmos is limited and has obvious adverse reactions. Biologics targeting IGF-1R can significantly improve the symptoms of exophthalmos in patients with thyroid eye disease and improve their quality of life, and are bound to play an important role in the treatment of thyroid eye disease.” Professor Fan Xianqun, an academician of ...
- Source: drugdu
- 177
- March 18, 2025

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