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.
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.
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.
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.
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.
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