Qiming Star | CANbridge Pharma's velaglucerase alfa for injection (brand name: Gerining), a first-in-class drug for Type I and Type III Gaucher disease, approved for market launch in China
Gorenicin is not only the third rare disease treatment drug launched by CANbridge after Hymricin and Myrbetriq, but also the first self-developed product poised for commercialization.
Qiming Venture Partners portfolio company CANbridge Pharmaceuticals (01228.HK) announced that its wholly-owned subsidiary, CANbridge (Shanghai) Biopharmaceuticals Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for its velaglucerase alfa for injection (brand name: Gerining). Gerining is China's first domestically developed and self-researched long-term enzyme replacement therapy for adolescent and adult patients aged 12 and above with Type I and Type III Gaucher disease. Classified as a Category 1 innovative drug, it can fully substitute comparable imported products and will significantly improve drug accessibility for patients in China.
This marks not only CANbridge's third rare disease treatment to reach the market, following Hunterase and Maralixibat, but also its first self-developed product poised for commercialization.
CANbridge announced positive topline data from the pivotal clinical trial of Gerining in adult and pediatric Gaucher disease patients last August. The Center for Drug Evaluation (CDE) granted it priority review status in September. That October, CANbridge successfully passed the production and quality management system audit and on-site inspection for Marketing Authorization Holder (MAH) status, obtaining a Type B Pharmaceutical Manufacturing License. In November, the New Drug Application (NDA) for Gerining was formally accepted by the National Medical Products Administration (NMPA). This March, it successfully passed the registration inspection for the segmented manufacturing pilot program and the pre-market GMP compliance inspection, making Gerining China's first innovative biologic to pass segmented manufacturing inspection for biological products.
Dr. Xue Qun, Founder, Chairman, and CEO of CANbridge, stated: "Enzyme replacement therapy represents a crucial component of CANbridge's global pipeline strategy, and Gerining's approval in China carries milestone significance. The journey from NDA submission to formal approval took only six months, reflecting not only the favorable safety, efficacy, and reliability profile of our product and our regulatory affairs expertise, but also the recognition and support from national drug regulatory authorities for the urgent medical needs of Gaucher disease patients.
The innovative technology employed in Gerining involves enzyme modification and directed evolution; going forward, combined with continuous flow manufacturing process technology, this can be extended to other comparable drugs beyond Gaucher disease, enabling scaled and batch production. In the future, Gerining's platform technology will substantially reduce development costs, ensuring patients can access and afford safe, effective domestically produced enzyme replacement therapies. The successful development and approval of Gerining embodies the entrepreneurial founding mission of everyone at CANbridge. It would not have been possible without the concerted efforts of numerous partners including WuXi Biologics, the support of national and local regulatory agencies, relevant departments, and medical institutions, and above all, the hopes of Gaucher patients nationwide for sustainable treatment access.**
Gerining is the first collaborative project between CANbridge and WuXi Biologics in the rare disease space, and we extend our gratitude to partners including WuXi Biologics who enabled the development and manufacturing of this product. Going forward, we will continue to deepen our commitment to the localized R&D, production, market launch, and accessibility of rare disease drugs, bringing innovative treatment solutions to patients in China."
Dr. Chris Chen, CEO of WuXi Biologics, stated: "We are deeply honored to have empowered CANbridge in achieving the key milestone of Gerining's approval, which also represents a significant breakthrough in China's rare disease drug innovation. The path of rare disease drug development is long and arduous — from early laboratory discoveries to ultimately benefiting patients, countless technical hurdles and challenges must be overcome. The successful realization of this product from concept to commercial manufacturing stands as testament both to CANbridge's decade-long dedication to the rare disease field and to the successful practice of WuXi Biologics' integrated technology platform and CRDMO business model. The shared resonance between both parties in addressing unmet clinical needs for rare disease patients has yielded China's first domestically developed enzyme replacement therapy for Gaucher disease. We look forward to empowering more global partners to accelerate the development of high-quality rare disease therapeutics, driving innovation in rare disease drugs, and benefiting more patients affected by rare diseases."
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Founded in 2006, Qiming Venture Partners currently manages 11 USD funds and 7 RMB funds, with total assets under management reaching $9.5 billion. Since its inception, the firm has focused on investing in outstanding early- and growth-stage companies in the Technology and Consumer (T&C) and Healthcare sectors.
To date, Qiming Venture Partners has invested in over 580 high-growth innovative companies, of which more than 210 have listed on the New York Stock Exchange, NASDAQ, Hong Kong Exchanges and Clearing, Shanghai Stock Exchange, and Shenzhen Stock Exchange, or exited through M&A and other means. Over 80 portfolio companies have become recognized unicorns or super-unicorns.
Many companies in Qiming Venture Partners' portfolio have grown into the most influential players in their respective fields, including Xiaomi (01810.HK), Meituan (03690.HK), Bilibili (NASDAQ:BILI, 09626.HK), Zhihu (NYSE:ZH, 02390.HK), Roborock (688169.SH), UBTECH (09880.HK), WeRide (NASDAQ:WRD), Gan & Lee Pharmaceuticals (603087.SH), Tigermed (300347.SZ, 03347.HK), Zai Lab (NASDAQ:ZLAB, 09688.HK), CanSinoBIO (688185.SH, 06185.HK), Schrödinger (NASDAQ:SDGR), MicroPort EP MedTech (688617.SH), Sanyou Medical (688085.SH), Amoy Diagnostics (300685.SZ), Berry Genomics (000710.SZ), Sinocelltech (688520.SH), Yuanxin Technology, ClinChoice, Belief BioMed, Biren Technology, among others.