Recently, Eli Lilly announced plans to invest a total of $ 3 billion over the next ten years to fully expand its supply chain capacity in China . According to the plan, the $3 billion investment will adopt a dual-track model of ” internal expansion + external cooperation “: on the one hand, it will leverage the technological and talent advantages of the Suzhou factory to strengthen the synergistic production capacity of incretin injection; on the other hand, it will add oral solid dosage form production capacity in Beijing and cooperate with multiple local production partners to release incremental production capacity. As a key move in this round of investment, Eli Lilly also announced a strategic partnership with Kanglong Chemical , a leading domestic CDMO company , on the same day. The initial investment of $200 million will support Kanglong’s technological capabilities, with plans to gradually expand the scale as ...
According to recent foreign media reports, global medical device giant Medtronic announced that it will acquire Scientia Vascular for $550 million to strengthen its stroke treatment portfolio. Image source: Fierce Biotech Scientia Vascular is a company specializing in the manufacture of specialized guidewires, microcatheters, and access products for reaching complex blood clots deep in the brain. According to data from PharmNet Medical Devices, the company has already launched 16 products in the United States. In 2021, Scientia completed a $50 million funding round, which the company reportedly used to accelerate sales, marketing, and new product development in its core neurovascular stroke market, as well as peripheral vascular and interventional oncology-related markets. Scientia’s process involves etching slots into a solid nickel-titanium alloy tube to form a closed loop and interconnected beams—allowing the guidewire to effectively transmit torque while meandering through the brain’s small, winding blood vessels. The company states that this ...
Diffuse large B-cell lymphoma ( DLBCL) is the most common type of non-Hodgkin lymphoma (NHL), accounting for 31%–34% of NHL cases globally and 45.8% in China. The incidence rate increases with age. Even after first-line treatment, 30%–40% of DLBCL patients face relapse or refractory outcomes, resulting in a poor prognosis and challenging survival.On March 13, 2026, according to the latest announcement on the official website of the National Medical Products Administration (NMPA) of China , Roche (China) Investment Co., Ltd. ‘s application for a new indication for injectable veportuzumab has been approved for marketing in China . According to Roche’s press release, the indication is: this product in combination with rituximab , gemcitabine, and oxaliplatin (Pola-R-GemOx) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not suitable for hematopoietic stem cell transplantation. Public information shows that vedotin (Urithema®, Polivy®) is an antibody-drug conjugate (ADC) targeting ...
Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a marketing authorization notice for carfilzomib issued by the National Medical Products Administration . This approval further enriches the company’s anti-tumor active pharmaceutical ingredient (API) product line. The product, manufactured using the same production line and process, has also been submitted for US approval, providing a better option for domestic and international pharmaceutical formulation customers. Carfilzomib, as a second-generation proteasome inhibitor, exerts significant anti-proliferative and pro-apoptotic effects on tumor cells by irreversibly binding to the 20S proteasome active site. Its high selectivity results in a lower risk of neurotoxicity, and it is well tolerated by patients. Clinical data confirm that it has a reliable safety advantage in the treatment of multiple myeloma and is the preferred clinical option. Established in 2017, the International Drug R&D Center adheres to an international strategy of “based in China, radiating ...
Kelun Pharmaceutical’s oral disintegrating film for sildenafil citrate (50mg/25mg), submitted as a Class 3 chemical drug, has been officially approved for marketing. This not only means that the first company in China to launch this new dosage form of the drug, but also that Kelun Pharmaceutical has become the “first generic manufacturer of sildenafil citrate oral disintegrating film in China” with this approval, and is regarded as the first company to pass the consistency evaluation. In the fiercely competitive market of andrology drugs, sildenafil, a “super product” with its own built-in traffic, has always been a battleground for companies. According to data from PharmNet, the domestic sildenafil market has maintained a high scale in recent years, with total sales reaching 6.6 billion yuan in 2023 and remaining at a massive 6.3 billion yuan in 2024. Faced with such a huge market worth tens of billions of yuan for treating erectile ...
According to recent foreign media reports, GE Healthcare announced that it has completed the previously announced acquisition of Inteleraad for $2.3 billion (approximately RMB 15.87 billion). GE Healthcare officially announced last November that it would acquire Inteleraad for $2.3 billion. Inteleraad, founded in 1999, reportedly possesses imaging software and digital enterprise workflow solutions, and has a significant presence in the outpatient healthcare field. According to data from Yaozhi Medical Devices, Inteleraad currently has several marketed products in the United States. Of particular note is Inteleraad’s ability to provide cloud-first products designed specifically for radiology and cardiology, covering both inpatient and outpatient medical environments. This is a major reason why GE Healthcare was willing to acquire Inteleraad for a hefty sum. With the completion of the transaction, Intelerad will operate as part of GE Healthcare’s medical imaging business, and GE Healthcare expects Intelerad to continue serving enterprise imaging solutions customers in ...
Recently, Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Hengrui Medicine, received an “Acceptance Notice” from the National Medical Products Administration. The drug application for marketing authorization of the company’s independently developed Class 1 new drug, Likang Kepan Capsules of Fumarate, has been accepted. The indication is: treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who still have anemia after previous treatment with C5 complement inhibitors. This is expected to bring new options for the treatment of this rare disease. Research on HRS-5965-302 This application for market approval is based on a multicenter, single-arm, open-label phase III clinical trial evaluating the efficacy and safety of Likang Kepan fumarate capsules (development code: HRS-5965) in PNH patients who still have anemia after 6 months of stable treatment with C5 complement inhibitors. The study was jointly led by Professor Shi Jun of the Institute of Hematology and Blood Diseases Hospital of Chinese ...
IN026 is a potential first-in-class mRNA therapy for refractory gout, marking the official entry of DeepBio’s independently developed mRNA-LNP platform into a new treatment category. Hong Kong, Shenzhen, and Boston, USA – March 18, 2026 – Sangfor Biotech, a clinical-stage biotechnology company focused on RNA drug development, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its mRNA drug candidate, IN026, an investigational mRNA therapy for refractory gout. Following this IND approval, the company will systematically evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IN026 in a Phase 1 clinical trial in this unmet medical need patient population. IN026 achieves systemic degradation of uric acid in vivo by delivering mRNA encoding uricase (UOX) to the liver. “Refractory gout is a disease that can severely impact patients’ mobility and quality of life. Existing treatments are often limited in their effectiveness due ...
Drugdu.com expert’s response: I. Application Requirements 1. Basic Requirements Possess production facilities, environmental conditions, manufacturing equipment, and qualified technical personnel suitable for the medical devices to be produced. Establish a quality inspection department staffed with full-time inspectors and equipped with necessary testing instruments. Develop and implement a quality management system covering production, quality control, and technical documentation to ensure medical device quality. Demonstrate after-sales service capabilities appropriate for the medical devices produced. 2. Personnel Requirements Production, quality, and technical managers must possess professional expertise relevant to the medical devices produced and be familiar with applicable regulations and technical standards. The quality manager shall not concurrently serve as the production manager. The proportion of technical personnel with junior professional titles (or above) or secondary vocational education (or higher) within the enterprise must meet product-specific requirements. For Class III medical device manufacturers, at least two internal auditors compliant with quality management system ...
On March 19, Baiyang Pharmaceutical (301015.SZ) announced that it plans to sign an investment agreement with Sihe Gene (Beijing) Biotechnology Co., Ltd. (hereinafter referred to as “Sihe Gene”), agreeing to invest RMB 27 million in cash in Sihe Gene. After the investment, Baiyang Pharmaceutical will hold a 10% stake in Sihe Gene. Through this cooperation, Baiyang Pharmaceutical strategically secures the global priority right to acquire and commercialize all of Sihe Gene’s pipeline projects. This marks Baiyang Pharmaceutical’s official entry into the golden track of small nucleic acid therapy, opening a new chapter in its next-generation innovative therapy layout. Small nucleic acid drugs are hailed as the “third wave of pharmaceutical development” following small molecule drugs and antibody drugs. In recent years, with continuous breakthroughs in core technologies such as delivery systems and chemical modification, China’s nucleic acid drug sector is gradually emerging, becoming another golden track for innovative drugs after ...
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