Bountiful Results | January–July 2026: Kangchuanji Pharmaceutical, in collaboration with multiple pharmaceutical companies, secured approval or passed the evaluation for 15 product specifications.
2026-08-04
From January to July 2026, Nanjing Kangchuanji Pharmaceutical Technology Co., Ltd., leveraging its deep-rooted expertise in pharmaceutical R&D and a mature one-stop… CDMO With end-to-end service capabilities, we deeply empower our partner pharmaceutical companies in innovative R&D and the translation of research outcomes, and have once again achieved outstanding regulatory review results in collaboration with numerous partners. According to the NMPA’s public announcements of drug approval documents, a total of 12 products (covering 15 specifications) have been successfully approved or passed consistency evaluation, demonstrating significant progress in translating innovative scientific advances into tangible results.
Among the many successful implementations, several flagship benchmark products have broken through industry‑wide technological barriers, underscoring Kangchuanji Pharmaceutical’s robust R&D and technical consulting capabilities as well as its strong industrialization expertise.
✨ The world’s first Class 1 innovative drug: Loblutinib Tablets
Lobutinib Tablets It is the world’s first Class 1 innovative drug of the fourth-generation BTK inhibitor. It has received NMPA priority review and conditional approval for dual‑channel market access, with上市 technical consulting services provided by Kangchuanji Pharmaceutical. Leveraging an innovative “covalent + non‑covalent” dual‑mechanism safeguard, it specifically addresses the C481S resistance bottleneck, offering a solution for relapsed or refractory patients who have failed prior BTK inhibitor therapy. MCL Patients, offering a new and highly effective second-line treatment option.
✨ Class 1 Innovative Drug: Isotretinoin Hydrochloride Tablets
This product has received conditional approval from the NMPA for market launch and is an oral small-molecule drug for the treatment of COVID‑19. As a significant innovative achievement in domestically developed oral COVID‑19 therapeutics, it further expands China’s portfolio of COVID‑19 treatment options.
✨ China’s first evaluated–approved isosorbide dinitrate tablet
Supporting Partner Companies Tianjin Pacific Pharmaceutical Co., Ltd. This variety has achieved The nation’s first to pass the consistency evaluation. Through rigorous R&D and quality‑control processes, we have demonstrated the bioequivalence of our generic products to the originator drugs, providing high‑quality, cost‑effective alternatives for clinical use in the cardiovascular field.
✨ Self-developed and self-owned product: Sildenafil Citrate Orally Disintegrating Tablets
The company’s proprietary varieties are characterized by Class 4 generic chemical drugs Having successfully obtained marketing approval, it is deemed to have passed the consistency evaluation, thereby expanding the company’s portfolio of proprietary products.
✨ A batch of essential generic drugs has received approval in a concentrated rollout, covering multiple therapeutic areas and advancing equitable access to care.
In addition to its flagship blockbuster products, the company has achieved a broad array of generic‑drug successes this year, spanning key therapeutic areas such as gastroenterology, endocrinology, cardiovascular health, pediatrics, and psychiatry, and encompassing a diverse range of dosage forms—including injectables, oral tablets, sustained‑release combination formulations, and granules. All products meet or exceed the quality and efficacy standards of their originator counterparts, precisely addressing clinical needs in primary care, chronic disease management, pediatric specialties, and niche therapeutic fields. Leveraging its robust R&D capabilities across multiple therapeutic domains, with a full spectrum of dosage forms and uncompromising quality, the company is effectively closing critical gaps in domestic clinical drug availability, accelerating the localization of generic medicines, and driving inclusive, high‑quality upgrades to grassroots healthcare.
From pioneering innovative drug R&D to the commercialization of high‑end generic medicines, and from tackling technical challenges to navigating regulatory review and approval, Kangchuanji Pharmaceutical consistently delivers professional, efficient, one‑stop CDMO services, providing end‑to‑end support to ensure the smooth and rapid advancement of each product through the review and approval process. Looking ahead, the company will continue to deepen its expertise in pharmaceutical R&D and industrialization, leveraging technological innovation as its core driver to help more pharmaceutical companies accelerate the launch of their products and contribute to the high‑quality, innovative development of China’s pharmaceutical industry.
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