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SINOPHARM New Drug Application Accepted

On July 10, SINOPHARM (01177) announced that the Group’s independently developed CDK2/4/6 inhibitor Cumocillin Capsules “TQB3616” combined with Fulvestrant Injection for previously untreated HR-positive, HER2-negative (HR+/HER2-) locally advanced or metastatic breast cancer has been submitted to the Center for Drug Evaluation of the China National Medical Products Administration for new indications for marketing approval and has been accepted. The approval of the first-line indication application further confirms the broad potential of this combination therapy in different treatment stages of advanced breast cancer. In addition, the new drug application for Cumosili submitted by the Group in July 2024 has also been accepted by the CDE for use in combination with Fulvestrant for the treatment of HR+/HER2- locally advanced or metastatic breast cancer that has been previously treated with endocrine therapy. The announcement mentioned that breast cancer is one of the most common malignant tumors in women, of which HR+/HER2- breast cancer ...
- Source: drugdu
- 144
- July 14, 2025
【EXPERT Q&A】How to standardize drug information?

Drugdu.com expert’s response: Standardizing drug information is a critical step in enhancing medical data quality, facilitating information sharing, and ensuring medication safety. Below are the specific methods and steps to achieve drug information standardization: I. Clarify Standardization Objectives and Scope Define Core Objectives Improve Data Consistency: Ensure consistent naming and dosage representations of the same drug across different systems. Support Cross-System Interoperability: Enable data exchange among hospitals, pharmacies, and regulatory agencies. Ensure Medication Safety: Avoid medication errors caused by information confusion. Meet Regulatory Requirements: Comply with national drug coding standards, electronic health record (EHR) specifications, etc. II. Define Standardization Scope Basic Information: Drug names, ingredients, dosage forms, specifications, manufacturers, etc. Clinical Information: Indications, usage and dosage, contraindications, adverse reactions, etc. Administrative Information: Drug codes, classifications, prices, inventory, etc. Research Information: Pharmacokinetic parameters, clinical trial data, etc. Establish a Unified Drug Information Standard System Adopt International/National Standards Drug Coding: Utilize internationally ...
- Source: drugdu
- 240
- July 14, 2025
【EXPERT Q&A】What are the standards and procedures for compliance review?

Drugdu.com expert’s response: I. Standards for Compliance Review The standards for compliance review serve as benchmarks to ensure that the actions of enterprises or organizations are lawful and compliant, primarily covering the following three aspects: Legal and Regulatory Requirements National Laws and Regulations: These include the Constitution, laws, administrative regulations, departmental rules, and local regulations, such as the Company Law, Labor Law, and Cybersecurity Law. International Treaties and Regulatory Provisions: For foreign-involved enterprises, compliance with the laws and regulations of the host country where investments are made, international conventions (e.g., GDPR), and bilateral treaty agreements is required. Industry Regulatory Requirements: Examples include capital adequacy ratios and risk management regulations in the financial sector, as well as medical device approval processes in the healthcare industry. Industry Standards and Best Practices Industry Codes: Examples include the Basel Accords in the financial sector and ISO 13485, the quality management system standard for medical devices. Social Responsibility ...
- Source: drugdu
- 206
- July 11, 2025
The application for the marketing approval of the innovative drug in the field of autoimmune diseases jointly developed with Connect Biopharmaceuticals has been accepted

Simcere Pharma (02096) announced on the evening of July 8 that the company and Hong Kong Connect BiopharmaceuticalsInnovative drugs developed by pharmaceutical companiesThe New Drug Application (NDA) for Ledeqibaimab has been accepted by the China National Medical Products Administration (NMPA) and is intended for the treatment of atopic dermatitis in adults and adolescents. Ledeqibaimab is a fully human monoclonal antibody targeting IL-4Rα (a common subunit of IL-4 and IL-13 receptors). By blocking the functions of IL-4 and IL-13, the drug can effectively inhibit the Th2-type inflammatory pathway, thus providing a possible treatment for Th2-related inflammatory diseases such as atopic dermatitis and asthma. According to reports, Connect Biopharma is a global clinical-stage biopharmaceutical company focused on the development of innovative therapies for inflammatory diseases. In addition to atopic dermatitis, the company is conducting global studies on Ledeqibaimab for the treatment of acute exacerbations of asthma and chronic obstructive pulmonary disease (COPD) ...
- Source: drugdu
- 158
- July 10, 2025
Kanghua Biopharma terminates cooperation in tuberculosis and rabies vaccine research and development

On July 8, Kanghua Bio(300841) issued an announcement that the company reached an agreement with Chengdu Xinran Bochuang Biotechnology Co., Ltd. (Xinran Bochuang) and decided to terminate the research and development project on tuberculosis mRNA vaccine, and at the same time terminate the subsequent research and development cooperation on rabies mRNA vaccine and herpes zoster mRNA vaccine. This decision was made based on the company’s established independent R&D team for the mRNA technology platform and the completion of the transfer of collaborative R&D results, combined with the company’s overall business development plan. The announcement mentioned that Sinopharm has completed the relevant research on rabies mRNA vaccine and shingles mRNA vaccine, and delivered the results to the company, and the company has paid the corresponding amount; however, the tuberculosis mRNA vaccine project has not yet been launched and no expenses or work results have been generated. In the agreement to terminate ...
- Source: drugdu
- 149
- July 10, 2025
Small nucleic acid therapy challenges GLP-1 giants

RNAi technology targets the core shortcomings of GLP-1 drugs by precisely regulating the expression of obesity-related genes. With the disruptive advantage of “reducing fat without losing muscle”, RNAi therapy is strongly challenging the “hegemony” of the GLP-1 market worth hundreds of billions! 01The wave of small nucleic acid therapy has arrived Small nucleic acid therapy, especially siRNA (small interfering RNA) technology, with its unique gene silencing mechanism and continuously innovative delivery technology, jointly promotes the expansion of treatment areas from rare diseases to chronic diseases, leading the third wave of innovation in the biomedicine field. From the technical principle, siRNA achieves precise gene silencing through the RNA interference (RNAi) mechanism. In its double-stranded structure, the guide strand (antisense strand) is loaded into the RISC complex and then specifically binds to the target mRNA and guides its degradation, thereby blocking the expression of pathogenic proteins; while the guest strand (sense strand) ...
- Source: drugdu
- 195
- July 10, 2025
Baili Tianheng BL-B01D1 Update Progress

Recently, the world’s first dual-antibody ADC drug BL-B01D1 independently developed by Baili Tianheng has made significant progress in the Phase III clinical trial for the treatment of locally advanced or metastatic nasopharyngeal carcinoma. The analysis results show that the drug has successfully reached the primary endpoint and may bring new treatment options for nasopharyngeal carcinoma patients. Nasopharyngeal carcinoma is a highly invasive and recurrent head and neck malignant tumor. Although immunotherapy and targeted therapy have made some progress in recent years, treatment options are still limited for patients with recurrent or metastatic nasopharyngeal carcinoma, especially those who have failed multiple lines of treatment. Baili Tianheng’s BL-B01D1 came into being in this context. With its unique innovative drug mechanism, it brings new ideas to the treatment of nasopharyngeal carcinoma. BL-B01D1 is an EGFR×HER3 dual-antibody ADC drug. Its design principle is to simultaneously target two key targets, epidermal growth factor receptor (EGFR) ...
- Source: drugdu
- 556
- July 10, 2025
FDA Approves KalVista Pharmaceuticals’ Ekterly for Hereditary Angioedema

The FDA has approved KalVista Pharmaceuticals’ Ekterly (sebetralstat) as the first and only oral on-demand treatment for hereditary angioedema (HAE) attacks in patients aged 12 years and older. According to the company, approval was based on results from the Phase III KONFIDENT trial (NCT05259917), which was the largest clinical study ever conducted in HAE. Results from the trial showed faster symptom relief and attack resolution among patients administered Ekterly compared to placebo, along with strong efficacy and a favorable safety profile.1 How does Ekterly Change the Treatment Landscape for HAE? “The FDA approval of Ekterly is a defining moment for people living with HAE,” said Ben Palleiko, CEO, KalVista, in a press release. “Ekterly enables people to treat attacks the moment symptoms begin, wherever they are. This approval affirms the strength of our science and deep commitment to the HAE community. I am profoundly grateful to the KalVista team for ...
- Source: drugdu
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- July 10, 2025
The First Drug to Treat Infants Sick With Malaria Is Approved by Swiss Authority

GENEVA (AP) — Switzerland’s medical products authority has granted the first approval for a malaria medicine designed for small infants, touted as an advance against a disease that takes hundreds of thousands of lives — nearly all in Africa — each year. Swissmedic gave a green light Tuesday for the medicine from Basel-based pharmaceutical company Novartis for treatment of babies with body weights between 2 and 5 kilograms (nearly 4½ to 11 pounds), which could pave the way for hard-hit African nations to follow suit in coming months. The agency said that the decision is significant in part because it’s only the third time it has approved a treatment under a fast-track authorization process, in coordination with the World Health Organization, to help developing countries access needed treatment. The newly approved medication, Coartem Baby, is a combination of two antimalarials. It is a lower dose version of a tablet ...
- Source: drugdu
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- July 10, 2025
Medical Japan Osaka

Organiser: RX Japan Ltd. Time：March 10-12, 2026 address：1-5-102 Nanko-Kita, Suminoe-ku, Osaka, 559-0034 Japan Exhibition hall：Intex Osaka Product range: Medical Equipment: Medical electronic instruments, ultrasonic instruments, X-ray equipment, medical optical instruments, clinical laboratory analytical instruments, dental equipment and materials, hemodialysis equipment, anesthesia and respiratory equipment, etc.; disposable medical supplies, dressings, and hygienic materials, various surgical instruments. Medical Supplies: Medical electronic instruments, medical ultrasonic instruments, medical X-ray equipment, medical optical instruments, clinical laboratory analytical instruments, dental equipment and materials, operating room, emergency room, and consultation room equipment and appliances, diagnostic equipment and supplies, disposable medical supplies, medical dressings, and hygienic materials, various surgical instruments, medical health care equipment and supplies, traditional Chinese medical instruments and rehabilitation devices, hemodialysis equipment, anesthesia and respiratory equipment, etc.; home health care products, small home diagnostic, monitoring, and treatment instruments, rehabilitation and physiotherapy instruments and supplies, electronic medical instruments, dental tools, hospital office supplies, sports medicine supplies. ...
- Source: drugdu
- 239
- July 10, 2025

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