Congratulations! FAB Supports Approval of the World’s First Paclitaxel Oral Solution in China!

On September 25, 2024, the official website of China's National Medical Products Administration (NMPA) announced that the New Drug Application for an paclitaxel oral solution, collaboratively developed by Haihe Biopharma Co., Ltd. and Dae hwa Pharmaceutical Co., Ltd, has been approved. It is indicated for the treatment of advanced gastric cancer in patients who have experienced disease progression during or after first-line fluoropyrimidine-containing chemotherapy. FAB, as a leading domestic imaging CRO, provided comprehensive third-party Independent Review Committee (IRC) services for the Phase III clinical study of this drug.

Source: NMPA

As the world's first successfully developed oral formulation of paclitaxel, the efficacy of RMX3001 was confirmed in the Korean Phase III DREAM study and it was approved in South Korea for second-line treatment of gastric cancer.

The approval in China is primarily based on a randomized, open-label, parallel-controlled, non-inferiority, multicenter Phase III clinical trial conducted in China. This study once again confirmed that the oral paclitaxel solution offers clear efficacy and a manageable safety profile in patients with inoperable, recurrent, or metastatic advanced gastric cancer after first-line therapy.

From April 22, 2019, to January 31, 2022 (data cut-off date), the study enrolled 536 patients from 53 centers. Patients were randomized to the oral paclitaxel solution group (n=268) or the intravenous paclitaxel injection group (n=268), with median follow-up times of 13.4 months and 12.6 months, respectively. The median Progression-Free Survival (mPFS) assessed by the Blinded Independent Review Committee (BIRC) was 3.02 months in the oral paclitaxel group compared to 2.89 months in the intravenous paclitaxel group, demonstrating non-inferiority of the oral solution (HR 0.894, 95% CI: 0.719, 1.112, p=0.311). As of February 15, 2023, the median Overall Survival (mOS) was 9.13 months in the oral paclitaxel group compared to 6.54 months in the intravenous paclitaxel group, indicating superiority of the oral solution with a median OS extension of 2.59 months (HR 0.770, 95.5% CI: 0.635, 0.934, p=0.006). Regarding safety, the overall profile was tolerable. Common Grade ≥3 adverse events were hematologic toxicities such as decreased neutrophil count and decreased white blood cell count. The oral paclitaxel solution demonstrated advantages in reducing the incidence of side effects including alopecia, peripheral neuropathy, fatigue, various musculoskeletal and connective tissue disorders, and allergic reactions.

Since 2019, as the service provider, FAB was responsible for the third-party independent image evaluation for the pivotal clinical study supporting this product's approval in China. Leveraging deep industry expertise, extensive practical experience, a seasoned expert team, an efficient project management system, and strong medical support capabilities, FAB ensured the timely and high-quality delivery of project outcomes, providing robust support for the successful approval of the product.

An electronic gastric cancer evaluation system was developed according to the efficacy endpoint assessment requirements. This system achieved fully electronic and integrated management from evaluation to oversight, significantly improving the efficiency and accuracy of efficacy assessments, ensuring the integrity of database records and storage, and safeguarding the authenticity and reliability of the clinical study endpoint data.

Throughout the project, FAB maintained close and efficient communication with all parties. Whether it involved protocol review, data collection, or consulting on and resolving specialized imaging issues, FAB strived for rapid response and precise implementation. Guided by client needs, FAB strictly adhered to all timelines and Standard Operating Procedures (SOPs), ensuring the on-time achievement of every key milestone. This demonstrated FAB's high sense of responsibility and execution capability, earning the trust and praise of all involved parties.

FAB has undertaken IRC work for several clinical studies in the field of gastric cancer, all of which are progressing steadily. Founder Dr. Luxia Liang previously served as Medical Director for a large-scale global late-stage gastric cancer clinical trial – the Japanese Taiho S-1 project, which enrolled over 1,000 subjects. Dr. Liang personally managed and supervised the IRC image review work for that project. The drug involved was successfully launched in Japan, the US, Europe, and China. This experience not only reflects the profound expertise of the FAB team but also instills greater confidence in our partners.

It is worth mentioning that this oral paclitaxel solution is the second product from HaiHe Biopharma that FAB has supported. Previously, the MET inhibitor glumetinib was approved in China on March 7, 2023, and in Japan on June 24, 2024. Here, FAB extends its most sincere congratulations to our partner, HaiHe Biopharma, on this significant breakthrough in pharmaceutical innovation! The successful approval of this product is not only a high recognition of our collaborative achievements but also a powerful motivation for us to embark on new journeys together.

FAB looks forward to collaborating with more like-minded partners to advance the new drug development process and jointly contribute to the great cause of human health.