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Johnson & Johnson celebrates the launch of Rybrevant FASPRO (amivantamab subcutaneous injection) in China

As China’s first and currently only approved subcutaneous injection formulation for the treatment of EGFR-mutant advanced non-small cell lung cancer, Rybrevant FASPRO reduces the administration time from several hours with traditional intravenous infusion to just minutes, and significantly reduces the risk of infusion-related adverse reactions. Johnson & Johnson today announced the official launch of Rybrevant FASPRO (amivantamab injection, subcutaneous) in China, in combination with LECLIZE (lazertinib mesylate tablets) for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion or exon 21 L858R substitution mutation. Rybrevant FASPRO is the first and currently only subcutaneous injection formulation approved in China for the treatment of patients with EGFR-mutant advanced NSCLC. Combined with lazertinib, it demonstrates significant ease of administration in first-line combination therapy, reducing administration time from several hours to just minutes. In terms of safety, compared with the intravenous formulation, Rybrevant ...
- Source: drugdu
- 77
- September 17, 2026
First! Novartis’ blockbuster generic radiopharmaceutical receives approval

On September 14, Curium announced that Bexlutry ([177lu]oxooctreotide, development code: PNT2003) had received FDA approval. This drug is Lutathera ([177lu]oxooctreotide), i.e., a generic version. This is the world’s first approved generic radiopharmaceutical. The original drug, Lutathera, is a radioligand therapy (RLT) targeting the somatostatin receptor type 2 (SSTR2), acquired by Novartis through its acquisition of Advanced Accelerator Applications. It was first approved for marketing in the European Union in 2017. Currently, the drug is indicated for adult patients and children aged 12 years and older with unresectable or metastatic, progressive, well-differentiated (G1 and G2) SSTR-positive gastroenteropancreatic neuroendocrine tumors (GEP-NET). According to Novartis’ financial report, Lutathera’s global sales were $816 million in 2025. In November 2022, Lantheus acquired exclusive global rights to PNT2003 from POINT Biopharma, excluding China, Japan, South Korea, Indonesia, and Singapore. In October 2023, Eli Lilly acquired POINT Biopharma for $1.4 billion, gaining the remaining rights to the ...
- Source: drugdu
- 73
- September 17, 2026
the Uzbekistan Medical Devices Exhibition

Organiser：IEG Exhibition Company Time：September 15th – 17th, 2026 Address：Amir Temur Street, Tashkent, 700084107, Uzbekistan Exhibition hall：Uzekspocentre Exhibition Centre Product range: Medical Equipment: Medical electronic instruments, ultrasound instruments, X-ray equipment, medical optical instruments, clinical laboratory analytical instruments, dental equipment and materials, hemodialysis equipment, anesthesia and respiratory equipment, disposable medical supplies, dressings and hygiene materials, surgical instruments, hospital beds, operating tables, operating table spotlights, examination beds, dental chairs, in-hospital furniture Medical Supplies: Medical electronic instruments, medical ultrasound instruments, medical X-ray equipment, medical optical instruments, clinical laboratory analytical instruments, dental equipment and materials, operating room equipment and appliances, emergency room equipment and appliances, diagnosis room equipment and appliances, diagnostic equipment and supplies, medical health care equipment and supplies, traditional Chinese medical instruments and rehabilitation devices, home health care products, small household diagnostic instruments, home monitoring instruments, home therapeutic instruments, rehabilitation instruments and supplies, physiotherapy instruments and supplies, electronic medical instruments, dental tools, ...
- Source: drugdu
- 76
- September 17, 2026
【EXPERT Q&A】How are in vitro diagnostic kits developed?

Drugdu.com expert’s response: The R&D of in vitro diagnostic kits is a rigorous and standardized full-process system, with 5 core key stages that ultimately produce safe and effective products complying with regulatory requirements. Stage 1: Project Initiation and Preparation Clarify the target analyte to be tested, intended use and application scenarios, and complete research on market capacity, competing products and clinical demands. Confirm technical feasibility through literature review, form the project team, and prepare the project initiation assessment document for review and approval. Define core indicators such as product performance parameters and intended use, complete design input, and form the product summary materials required for registration. Stage 2: Product Development Raw material screening: Select no less than 3 qualified suppliers to ensure the quality of core raw materials (antigens, antibodies, primers, probes, etc.) is stable and traceable. Process and system optimization: Determine key parameters such as reagent formulation ratio, reaction ...
- Source: drugdu
- 71
- September 16, 2026
the German Pharmaceutical and Pharma Exhibition

Organiser：AVOXA Time：September 15th – 17th, 2026 Address：ostfach 10 10 06, D-40001 Dusseldorf Stockum Church Street 61, D-40474, Dusseldorf, Germany – D-40001 Exhibition hall：Dusseldorf Exhibition Center Product range: Pharmaceuticals, home care products, diagnostic instruments, dietary products, hygiene products, cosmetics, pharmaceutical accessories and displays, pharmacy DP, pharmacy supplies About Expopharm： Expopharm, the German Pharmaceutical and Pharma Exhibition, is an international pharmaceutical trade fair that has established itself as a leading trade show for the European pharmaceutical industry. It alternates between Düsseldorf and Munich. Founded in 1949, Expopharm started as a pharmaceutical exhibition covering all sectors of the pharmaceutical world, including pharmaceuticals, toiletries, food supplements, naturopathy, as well as pharmaceutical equipment and technical literature. At Expopharm, you will not find key decision-makers from all other sectors of the industry gathered anywhere else like this. Leading current manufacturers will present their latest innovations in the industry, top software companies will showcase the ...
- Source: drugdu
- 69
- September 15, 2026
【EXPERT Q&A】What is the process for applying for a medical device registration certificate?

Drugdu.com expert’s response: The application for a Medical Device Registration Certificate generally does not start with “preparing documents”. Instead, the first step is to confirm exactly which risk class the product belongs to. In China, medical devices are categorized into Class I, Class II and Class III based on their risk levels. Class I devices are subject to record-filing management, while the registration certificate application process is usually required only for Class II and Class III devices. Therefore, before formally launching the application, enterprises must first complete product classification judgment, confirming the product name, structural composition, intended use, working principle and risk level, to avoid taking a wrong path in subsequent tests, clinical evaluation and declaration. After the classification is confirmed, the enterprise needs to clarify the registration applicant and the production arrangement. That is to confirm who acts as the registration applicant, who is responsible for production, whether entrusted ...
- Source: drugdu
- 75
- September 14, 2026
Five innovative drugs approved for marketing

Recently, the National Medical Products Administration (NMPA) approved the marketing of five innovative drugs: Deuterated Aitinib Mesylate Tablets, Icosine Hydrochloride Tablets, Varigratetinib Tartrate Tablets, Veritumab Injection, and Lyconchitatumab Injection (subcutaneous). All five drugs were approved through the priority review and approval process. The NMPA conditionally approved the marketing of Deuterated Aitinib Mesylate Tablets submitted by Zhejiang Tongyuankang Pharmaceutical, indicated for adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletion or exon 21 substitution mutation, accompanied by central nervous system metastasis. The NMPA approved the marketing of Icosine Hydrochloride Tablets submitted by Janssen-Cilag, indicated for adult patients and children aged 12 years and above with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The NMPA conditionally approved the marketing of Varigratetinib Tartrate Tablets submitted by Hutchmed, indicated for adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma with FGFR2 fusion or ...
- Source: drugdu
- 91
- September 11, 2026
Subsidiary’s novel coronavirus mRNA vaccine receives drug registration certificate

On September 10, Walvax Bio (300142) announced that its wholly-owned subsidiary, Yuxi Walvax, recently received the “Drug Registration Certificate” for the novel coronavirus mRNA vaccine issued by the National Medical Products Administration (NMPA). This vaccine is the company’s third-generation COVID-19 mRNA vaccine, developed iteratively based on its mRNA platform technology strategy. The marketing authorization application was submitted and accepted earlier this year. The vaccine is designed based on the JN.1 strain and is indicated for individuals aged 18 years and above for the prevention of diseases caused by novel coronavirus infection. In the first half of 2026, Walvax Bio achieved revenue of 834 million yuan and net profit attributable to the parent company of 54.19 million yuan. Source: Eastmoney | https://finance.eastmoney.com/a/202609103870738792.html
- Source: drugdu
- 92
- September 11, 2026
Lincomycin Hydrochloride Injection passes generic drug consistency evaluation

On September 10, Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Hefeng Pharmaceutical Co., Ltd., recently received the “Drug Supplementary Application Approval Notice” for Lincomycin Hydrochloride Injection issued by the National Medical Products Administration (NMPA). The drug has passed the generic drug quality and efficacy consistency evaluation. This drug is indicated for respiratory tract infections, skin and soft tissue infections, etc., caused by susceptible bacteria such as Streptococcus, Pneumococcus, and Staphylococcus aureus. Source: Eastmoney | https://finance.eastmoney.com/a/202609103870825889.html
- Source: drugdu
- 81
- September 11, 2026
CSPC Pharmaceutical Group’s innovative chemical drug SYH2083 eye drops approved for clinical trials in China

On September 8, CSPC Pharmaceutical Group (1093.HK) announced that its Class 1 innovative chemical drug, SYH2083 eye drops, has been approved by the National Medical Products Administration (NMPA) of the People’s Republic of China to conduct clinical trials in China. This product is a small-molecule ophthalmic formulation with a novel mechanism of action. It treats ocular surface inflammation-related diseases by reducing T lymphocyte adhesion and activation, thereby lowering pro-inflammatory signals. Preclinical studies have shown that this product demonstrates significant pharmacodynamic activity in a mouse dry eye model, with a clear mechanism of action, indicating good clinical development potential. The approved clinical trial indication is dry eye syndrome, and the product also has the potential to be extended to other inflammatory ocular surface diseases such as allergic conjunctivitis. The approval of this product’s clinical trial will further enrich the Group’s innovative drug pipeline in the ophthalmology field. Source: WeChat Official Account ...
- Source: drugdu
- 80
- September 11, 2026

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