Innovation Accelerates in Pudong's Biopharma Sector with Multiple Breakthrough Products Gaining Approvals

(Source: Shangguan News)

Recently, the pace of innovation in Pudong’s biopharmaceutical industry has accelerated further. ShineyoMedical’s innovative product, the “Adjustable-Curve Pulmonary Artery Embolectomy Stent System,” has received approval for its registration application, adding another Class III medical device to Pudong’s portfolio.Innovative Medical Care(Rights Protection)Medical Devices: Pertuzumab, independently developed by Henlius, has been approved for market launch in China, establishing the first domestically produced “trastuzumab-pertuzumab dual-target” combination therapy approved in China, the United States, and Europe. MicroPort NeuroTech’s NUMEN™ Helia Coil Embolization System has received FDA marketing authorization, further deepening its international expansion. An increasing number of innovative pharmaceutical companies are achieving continuous breakthroughs on the fertile innovation ground of Pudong, with a dense rollout of innovative outcomes that accelerate Pudong’s rise as a new global hub for the biopharmaceutical industry.

Pudong Adds Another Class III Innovative Medical Device: Adjustable-Curved Pulmonary Artery Embolectomy Stent System Approved for Market Launch

According to the official WeChat account of the Shanghai Medical Products Administration, the National Medical Products Administration has recently approved the innovative product registration application for the "Adjustable Curved Pulmonary Artery Embolectomy Stent System" submitted by the Pudong-based biopharmaceutical enterprise Shanghai ShineyoMedical Co., Ltd.

It is reported that the product is available in steerable and coated versions, and consists of a thrombectomy stent catheter, an aspiration catheter, and accessories. It is indicated for catheter-based thrombus removal treatment in patients with acute high-risk pulmonary embolism or intermediate-risk pulmonary embolism accompanied by clinical deterioration, who have thrombi in the main pulmonary artery or its major branches and are at high risk of bleeding or have contraindications to thrombolysis, or who have failed thrombolysis or aggressive medical therapy.

As one of the regions in China with the most complete biomedical industry chain, the finest ecosystem, the greatest concentration of talent, the most efficient R&D, and the most vibrant innovation, Pudong focuses on Zhangjiang Pharma Valley and is committed to building a global source of biomedical innovation. Since the beginning of this year, a total of 13 Class III innovative medical devices have been approved for market launch in Shanghai, 10 of which originated from Pudong.

Pertuzumab Approved in China; Henlius Builds First Chinese-Made “Trastuzumab-Pertuzumab Dual-Target” Combination Approved in the US, China, and Europe

Recently, Henlius, a biopharmaceutical company based in Pudong, announced that the National Medical Products Administration (NMPA) has approved its New Drug Application (NDA) for pertuzumab (brand name: Hanbeiyou®; brand name in the US and Europe: POHERDY®), independently developed by the company. The approval is for neoadjuvant and adjuvant treatment of HER2-positive early breast cancer, as well as for the treatment of metastatic breast cancer, covering all indications already approved in China for the originator pertuzumab injection.

This approval signifies that the product has now received regulatory clearance in the three major markets of China, the European Union, and the United States. Together with the independently developed Hanquyou® (trastuzumab; marketed as HERCESSI™ in the US and Zercepac® in Europe), it forms the first Chinese-made “dual-target trastuzumab-pertuzumab” regimen approved in China, the US, and Europe, further solidifying its leading global footprint across the entire spectrum of breast cancer treatment.

Breast cancer is the second most common malignancy worldwide and the most prevalent cancer among women globally. The dual-targeted regimen combining pertuzumab and trastuzumab has become the cornerstone of standard treatment for HER2-positive breast cancer. The recent approval in China was primarily based on a review of a series of studies comparing the biosimilar with the reference pertuzumab, including analytical similarity studies, pharmacokinetic similarity studies, and clinical comparative studies, which demonstrated high similarity to the reference product in terms of quality, safety, and efficacy.

Enhancing the Product Portfolio: Minimally Invasive NeuroScience’s NUMEN™ Helia Coils Receive FDA Marketing Authorization

Recently, the NUMEN™ Helia Coil Embolization System, developed by MicroPort NeuroTech, a subsidiary of MicroPort NeuroScience, a Pudong-based biopharmaceutical enterprise, has received marketing authorization from the U.S. Food and Drug Administration (FDA).

This approval marks the third coil product launched by MicroPort NeuroTech in the U.S. market, following the NUMEN™ Detachable Coils and the NUMEN™ Silk 3D Electrolytic Detachable Coils, demonstrating its continuous breakthroughs in the R&D of innovative neurointerventional products and international regulatory registrations, while also helping to meet broader clinical needs for neurovascular embolization therapy.

NUMEN™ Helia is indicated for endovascular occlusion or embolization of neurovascular abnormalities to interrupt blood flow. Compared with other marketed coil products in the same series, NUMEN™ Helia features a “longer, thinner, and softer” design, is compatible with 0.013-inch microcatheters, and meets the delivery and embolization needs in small, tortuous, or access-limited vessels, providing a more refined solution for the treatment of complex vascular lesions.

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