Kexing Biopharm Facility Passes EU GMP Certification for Paclitaxel for Injection (Albumin Bound)
Kexing Biopharm Facility Passes EU GMP Certification for Paclitaxel for Injection (Albumin Bound)
SHENZHEN, China, May 10, 2024 /PRNewswire/ -- On the evening of May 5, Kexing Biopharm (stock code: 688136) announced it had obtained a "Certificate of GMP Compliance of a Manufacturer" granted by the Norwegian Medical Products Agency in accordance with the European Medicines Agency (EMA) regulations.
中國深圳，2024年5月10日 /PRNewswire/ — 5月5日晚，科興生物製藥（股票代碼：688136）宣佈已獲得挪威醫療產品管理局根據歐洲藥品管理局（EMA）的規定頒發的 “製造商GMP合規證書”。
The certification is a milestone for Kexing Biopharm, whose first drug for cancer therapy, Paclitaxel for Injection (Albumin Bound) , can now be registered in the EU as the company overcomes the primary obstacle and officially embarks on its journey into the EU pharmaceutical market.
該認證對科興生物來說是一個里程碑。隨着科興生物克服主要障礙並正式踏上進入歐盟醫藥市場的征程，科興生物的首款癌症治療藥物紫杉醇（Albumin Bound）現在可以在歐盟註冊。
Since its initial public offering, Kexing Biopharm has actualized international strategies, focusing on high clinical value, a high technical level, high international quality management and registration standards, and fast commercialization to expand its portfolio to 13 products. Paclitaxel for Injection (Albumin Bound) is Kexing Biopharm's first drug for cancer therapy. The manufacturing of the drug requires production equipment of a higher level, technical expertise of an advanced level, incredibly stringent aseptic management of the lean manufacturing process, and pharmaceutical processes of great complexity. The potential of the drug on the EU market prompted Kexing Biopharm to establish an EU cGMP-compliant brand-new production line that would enable the company to integrate research, production and marketing to capitalize more effectively on market opportunities.
自首次公開募股以來，科興生物製藥已實現了國際戰略，專注於高臨床價值、高技術水平、高國際質量管理和註冊標準以及快速商業化，將其產品組合擴展到13種產品。注射用紫杉醇（白蛋白結合型）是科興生物製藥的第一種癌症治療藥物。藥物的製造需要更高水平的生產設備、先進的技術專業知識、極其嚴格的精益製造過程無菌管理以及極其複雜的製藥工藝。該藥物在歐盟市場的潛力促使科興生物製藥建立了一條符合歐盟CGMP的全新生產線，這將使該公司能夠整合研究、生產和營銷，更有效地利用市場機會。
The characteristics of slight side effects, high efficacy and convenient injection make Paclitaxel for Injection (Albumin Bound) an ideal mainstream first-line treatment for metastatic pancreatic cancer and non-small cell lung cancer recommended by the European Society for Medical Oncology guidelines. Kexing Biopharm's decision to introduce this product was influenced by its efficacy and great market potential. Paclitaxel for Injection (Albumin Bound) is a collaborative effort between Kexing Biopharm and Haichang Biotech and has been submitted for marketing authorization simultaneously both in China and the EU. IQVIA data reveals the market penetration rate of the drug to stand at a mere 15% in the EU.
注射用紫杉醇（白蛋白結合型）具有副作用小、療效高、注射方便的特點，成爲歐洲腫瘤內科學會指南推薦的轉移性胰腺癌和非小細胞肺癌的理想主流一線治療藥物。科興生物製藥推出該產品的決定受到其功效和巨大市場潛力的影響。注射用紫杉醇（白蛋白結合劑）是科興生物製藥和海昌生物合作開發的，已同時在中國和歐盟申請上市許可。IQVIA的數據顯示，該藥物在歐盟的市場滲透率僅爲15％。
Under the GMP mutual recognition among EU members, the certification signifies the compliance with EU GMP of the Paclitaxel for Injection (Albumin Bound) production line. Once Kexing Biopharm obtains the approval of an EU Marketing Authorisation Application (MAA) for this drug, it will be a pivotal success in its entry into the EU regulatory markets, marking a major step forward in its international development strategy.
根據歐盟成員之間的GMP相互認可，該認證表明注射用紫杉醇（白蛋白結合型）生產線符合歐盟GMP。一旦科興生物製藥獲得該藥物的歐盟上市許可申請（MAA）的批准，它將是其進入歐盟監管市場的關鍵成功，標誌着其國際發展戰略向前邁出的重要一步。
SOURCE Kexing Biopharm
來源：科興生物製藥
譯文內容由第三人軟體翻譯。