Recently, Kanghong Pharmaceutical released its 2025 annual report, showing annual revenue of 4.585 billion yuan, a year-on-year increase of 2.98%, and net cash flow from operating activities of 1.504 billion yuan, a year-on-year increase of 6.50%. This marks the fifth consecutive year of steady growth. In an industry context where innovative drugs face a high risk of failure and centralized procurement has become the norm, where does Kanghong Pharmaceutical’s growth resilience come from? The answer lies not only in its impressive surge in biopharmaceuticals, but also in its long-term, meticulous cultivation of traditional Chinese medicine. Data shows that the company’s traditional Chinese medicine segment achieved revenue of 1.496 billion yuan, a year-on-year increase of 5.80% , leading the overall growth rate. While the market chases one hot biopharmaceutical trend after another, it has quietly built an insurmountable moat in the field of traditional Chinese medicine. Focusing on the golden track ...
Drugdu.com expert’s response: CE Certification: Mandatory Safety Certification for Products Entering the EU Market CE certification serves as a mandatory safety certification for products to enter the European Union market, and the preparation of relevant documentation must strictly adhere to EU directives, such as the Low Voltage Directive (LVD), Electromagnetic Compatibility Directive (EMC), Medical Device Directive (MDD), etc. I. Core Documents (General Requirements) Technical File Product Description: Include the name, model number, specifications, intended use, and functional descriptions (covering all variant models). Design Drawings: General assembly drawings, component drawings, circuit diagrams (including electrical schematic diagrams and wiring diagrams), and mechanical drawings (if applicable). Risk Assessment Report: Identify risks throughout the product’s lifecycle (e.g., electrical safety, mechanical hazards, biocompatibility) in accordance with ISO 14971 and describe risk control measures. List of Conformity Standards: Clearly specify applicable EU directives (e.g., LVD 2014/35/EU, EMC 2014/30/EU) and harmonized standards (e.g., EN 60601-1, the general ...
On April 20, 2026 , GlaxoSmithKline (GSK) announced that its drug Blenrep (generic name: belantamab mafodotin) had been approved by the National Medical Products Administration (NMPA) of China. The approved indication is for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) in combination with bortezomib and dexamethasone (BVd regimen) who have received at least one prior line of therapy . This approval was based on the priority review process, and the combination therapy had previously been granted Breakthrough Therapy designation in China, both because it is expected to provide significant improvements over existing therapies. Core approval information and key data Approved regimen : Blenrep + bortezomib + dexamethasone (BVd). Target patients : Adult patients with relapsed or refractory multiple myeloma who have previously received at least one first-line treatment. Key advantages : 1) It is the first and only approved anti-BCMA (B-cell maturation antigen) therapy in ...
On April 20, Eli Lilly announced a major acquisition: it will acquire biotechnology company Kelonia Therapeutics for a total price of up to $7 billion (approximately RMB 47.7 billion) . At the heart of this acquisition is Kelonia’s disruptive in vivo CAR-T technology platform, iGPS . Traditional CAR-T therapy, hailed as a revolution in cancer treatment, is extremely complex and expensive: it requires extracting T cells from the patient, genetically modifying and expanding them in an external factory, and finally reinfusing them into the patient. This process takes weeks and is costly, severely limiting its accessibility. Kelonia’s technology bypasses this cumbersome process. At its core is a specially modified lentiviral vector that, through intravenous infusion, directly transforms ordinary T cells into CAR-T cells within the patient’s body, enabling them to precisely identify and attack cancer cells. This in vivo manufacturing model theoretically transforms CAR-T therapy from a highly personalized, custom-made ...
On April 21, Hualan Vaccine issued a major announcement: Ms. An Wenjue, aged 37, was formally elected Chairwoman of the company’s third board of directors and appointed its legal representative. This personnel change is far more than a simple generational shift. It marks the official entry of this billion-market-cap vaccine industry leader into a new development phase helmed by a post 85s leader. As the daughter of An Kang, founder of the Hualan Group, An Wenjue’s succession represents both the natural continuation of family business inheritance and a critical step for Hualan Vaccine to pursue high-quality development and breakthroughs amid profound restructuring in the vaccine industry. This transition not only shapes the future of a leading enterprise but also reflects the broader trend and thinking around “second-generation succession” in the pharmaceutical sector. From Finance to Overall Leadership An Wenjue’s path to the top has been built on more than a ...
Recently, Dizal Medicine announced that it will present multiple latest research achievements in non-small cell lung cancer (NSCLC) at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from May 29 to June 2, 2026. Among them, the results of the international multicenter Phase III clinical study “WU-KONG28” of sunvozertinib (Sunvozhe®) were selected for the Latest Breakthrough Abstract (LBA) oral presentation, becoming the first and currently only study in the EGFR exon 20 insertion mutation (ex20ins) NSCLC treatment field to receive the highest honor of LBA at the ASCO conference. “WU-KONG28” is an international multicenter Phase III, open-label, randomized controlled clinical study conducted in 16 countries and regions worldwide, covering major countries including China, the United States, and Europe. Dizal previously announced that the “WU-KONG28” study met its primary endpoint and achieved positive top-line results. The results showed that compared to platinum-based doublet chemotherapy, sunvozertinib demonstrated statistically ...
On April 13, 2026, Fosun Kairen’s autologous dual-target (targeting BCMA and CD19) CAR-T product FKC289 injection officially received clinical trial approval from the National Medical Products Administration (NMPA). The product is planned to undergo Phase I/II clinical studies in China for recurrent/refractory membranous nephropathy (R/R MN) and recurrent/refractory primary light chain amyloidosis (R/R ALA), with the application for recurrent/refractory membranous nephropathy being first-in-class. This approval marks the acceleration of FKC289’s development process, potentially benefiting patients soon. ExCell Bio extends warm congratulations to Fosun Kairen on the clinical approval of FKC289 injection! This achievement not only represents a breakthrough in autologous dual-target CAR-T applications in autoimmune diseases but also marks China’s CGT innovation moving toward higher quality development. ExCell’s domestically first OptiVitro® T cell serum-free medium bag (TE000-N072), with its core domestic quality, deeply empowers project development, working alongside excellent industry partners to accelerate the implementation of cutting-edge therapies. Chen Xu, ...
Organiser:Sinopharm Holdings Reed Exhibition Time: May 13 – May 15, 2026 Address:No. 333 Songze Avenue, Xujing Town, Qingpu District, Shanghai Exhibition hall:National Exhibition and Convention Center (Shanghai) Product range: Pharmaceutical active pharmaceutical ingredients (APIs), pharmaceutical excipients, natural extracts, chemical reagents, intermediates, fine chemical raw materials, Chinese medicinal raw materials, food raw materials and additives, veterinary drug raw materials, feed raw materials and additives, health supplement raw materials and additives, biotechnology, pharmaceutical research and development services, contract custom manufacturing services, registration and pharmaceutical affairs services, training services About API China: China International Pharmaceutical API Expo (API China), as the longest-established exhibition in China’s pharmaceutical sector, was initiated in 1968. The exhibits not only encompass over 24 major categories with more than 50,000 types of APIs but also include all excipients, functional ingredients, internal and external packaging materials, as well as production and testing equipment required for the manufacturing of pharmaceuticals ...
Just now, the National Medical Products Administration released information on drug notification documents delivered on April 21, 2026. A total of 9 application numbers received notification documents in this batch , all of which were marketing authorization applications. Among them: Simcere Pharmaceutical received a notification for its application for Ledeqibaimab injection , the reason for which is unknown. The application for its indication is: treatment of atopic dermatitis in adults and adolescents . Ledecibaimab is a highly potent anti -IL-4Rα monoclonal antibody that blocks IL-4Rα signaling induced by IL-4 and IL-13 , and inhibits TF-1 cell proliferation induced by IL-4 and IL-13 . It has the potential clinical significance of faster onset of action, lower dosing frequency, and higher clinical response rate. Ledikuma is developed by Connect Biopharmaceuticals Limited in Hong Kong. In November 2023 , Simcere Pharmaceutical acquired the Greater China rights to Ledikuma with an initial payment of ...
On April 21, according to the website of the National Medical Products Administration (NMPA), the NMPA has conditionally approved the marketing of the Class 1 innovative drug celvaartinib tablets (trade name: Herxinno) submitted by Bayer HealthCare Pharmaceuticals Inc. through the priority review procedure.This drug is indicated as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one systemic therapy. https://mp.weixin.qq.com/s/g4lHuTRty7BHotg4Y7M6hA
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