Liporaxel (paclitaxel oral) / Dae Hwa, HaiHe Biopharma - LARVOL DELTA

Paclitaxel oral solution versus paclitaxel injection as a second-line therapy in advanced gastric cancer: A randomized, open-label, non-inferiority phase 3 trial. (ASCO-GI 2025) - P3 | "Paclitaxel oral solution (Liporaxel), the world's first successfully developed oral formulation, is an alternative. Paclitaxel oral solution demonstrated non-inferiority in PFS and superiority in OS compared to paclitaxel IV, with clinically manageable and favorable safety profile, supporting paclitaxel oral solution as a second-line treatment option for gastric cancer"

Clinical • Head-to-Head • Metastases • P3 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Phase III of oral paclitaxel (DHP107) vs intravenous paclitaxel in HER2-negative recurrent or metastatic breast cancer (mBC): Primary analysis of a multinational optimal trial (NCT03315364). (ASCO 2025) - P2/3 | "DHP107 demonstrated comparable efficacy to IV paclitaxel with tolerable and manageable toxicity. These results establish DHP107 as an effective, convenient alternative to IV paclitaxel for patients with HER2-negative mBC, supporting its potential role in routine clinical practice."

Metastases • P3 data • Breast Cancer • Febrile Neutropenia • Gastric Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Immunology • Musculoskeletal Diseases • Neutropenia • Oncology • Pain • Rheumatology • Solid Tumor • Triple Negative Breast Cancer • HER-2

OPERA: a phase II study of DHP107 (oral paclitaxel) versus intravenous paclitaxel in patients with HER2-negative recurrent or metastatic breast cancer. (PubMed, Breast Cancer Res Treat) - P2 | "DHP107 is a tolerable and feasible treatment for patients with recurrent or metastatic HER2-negative breast cancer, with similar efficacy and safety to IV paclitaxel."

Clinical • Journal • P2 data • Alopecia • Breast Cancer • Fatigue • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Immunology • Oncology • Pain • Solid Tumor • HER-2

Paclitaxel oral solution versus paclitaxel injection as second-line therapy for advanced gastric cancer: a multicenter, open-label, randomized phase III trial. (PubMed, ESMO Open) - "These findings support the use of paclitaxel oral solution as a viable alternative second-line option for gastric cancer."

Journal • P3 data • Alopecia • Gastric Cancer • Immunology • Musculoskeletal Diseases • Oncology • Pain • Rheumatology • Solid Tumor

Metronomic Oral Paclitaxel Plus PD-1/ PD-L1 Inhibitor Maintenance in Advanced Lung Cancer (PULSE Study) (clinicaltrials.gov) - P4 | N=107 | Recruiting | Sponsor: Anhui Provincial Cancer Hospital

Checkpoint inhibition • New P4 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-L1

Oral Paclitaxel Solution With Immunotherapy and Concurrent SBRT as Neoadjuvant Treatment for Older Adults With NSCLC (clinicaltrials.gov) - P4 | N=78 | Recruiting | Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Checkpoint inhibition • IO biomarker • New P4 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1

A randomized, open-label, two-way crossover clinical trial to evaluate the food effect on pharmacokinetics and safety of DHP107 in patients with advanced solid tumors: the FEEL study. (PubMed, Cancer Chemother Pharmacol) - P1 | "This study suggests that the pharmacokinetics of DHP107 are unaffected by food and DHP107 can be taken with or without food."

Clinical • Journal • PK/PD data • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Dae Hwa Pharmaceutical announced on May 13 that the Ministry of Food and Drug Safety approved the additional indication for Liporaxel Solution as a 'first-line treatment for recurrent or metastatic HER2-negative breast cancer' (HIT News) - "According to the company, the approval was based on the multinational, multicenter, randomized, open-label Phase 3 OPTIMAL study, which enrolled 549 patients across 51 institutions in Korea, China, and Europe. In the study, Liporaxel Solution demonstrated non-inferiority to IV paclitaxel, recording a median progression-free survival of 10.0 months, overall survival of 32.6 months, and an objective response rate of 43.3%."

Korea approval • HER2 Negative Breast Cancer

GIST Oral Paclitaxel(Liporaxel) (clinicaltrials.gov) - P2 | N=28 | Recruiting | Sponsor: Asan Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Stromal Tumor • Oncology • Sarcoma • ANO1 • KIT • PDGFRA

OPTIMAL: Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy (clinicaltrials.gov) - P2/3 | N=549 | Active, not recruiting | Sponsor: Daehwa Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Nov 2028

Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

OPTIMAL: A Multinational Phase III Study of Oral Paclitaxel (DHP107) versus Intravenous Weekly Paclitaxel in HER2-Negative Recurrent or Metastatic Breast Cancer. (PubMed, Ann Oncol) - "DHP107 demonstrated non-inferior efficacy compared to IV paclitaxel, with a manageable safety profile, supporting its use as an effective and convenient alternative in HER2-negative breast cancer."

Journal • P3 data • Breast Cancer • Febrile Neutropenia • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Immunology • Neutropenia • Oncology • Pain • Solid Tumor • HER-2

Daehwa Pharmaceutical has secured the inclusion of its proprietary oral anticancer drug, Liporaxel Solution (active ingredient: Paclitaxel), on China's National Reimbursement Drug List (NRDL), paving the way for its expansion into the Chinese anticancer market. [Google translation] (BioTimes) - "Until now, the relatively high price of non-covered sales has been an obstacle to expanding prescriptions. However, with this NRDL listing, Liporaxel liquid will be subject to the same insurance standards in all medical institutions across China starting January 1, 2026, and the reimbursement price has been confirmed at 1,208 yuan for 300 mg/30 ml. The target for reimbursement is advanced gastric cancer patients who are receiving first-line 5-FU series chemotherapy or whose disease has progressed afterward."

Reimbursement • Gastric Cancer

OPTIMAL-BC: Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer (clinicaltrials.gov) - P=N/A | N=112 | Recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

OPTIMAL-BC: Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer (clinicaltrials.gov) - P=N/A | N=112 | Not yet recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

New trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Oral Paclitaxel Non-Inferior to IV Paclitaxel in HER2-Negative mBC (DocWire) - P2/3 | N=549 | OPTIMAL (NCT03315364) | Sponsor: Daehwa Pharmaceutical Co., Ltd. | "The investigators found that DHP107 was non-inferior to IV paclitaxel for the primary endpoint of investigator-assessed PFS (median PFS, 10.02 vs 8.54 months; hazard ratio [HR] 0.869, 95% confidence interval [CI], 0.707-1.068). They also observed comparable OS between the oral and IV paclitaxel arms (median OS, 32.95 vs 32.46 months; HR, 0.979; 95% CI, 0.769-1.246). Patients in the DHP107 arm had higher ORR (45.8% vs 39.7%) and DCR (93.5% vs 86.4%) than those in the IV paclitaxel arm. The authors noted no significant differences in QOL outcomes. Median PFS findings for patients with HR-positive disease were similar to those of the overall population (10.74 vs 9.07 months; HR, 0.869; 95% CI, 0.700-1.080)."

P2 data • HER2 Negative Breast Cancer

Dizal to Highlight its Portfolio Advances in Hematologic Malignancies and Lung Cancer at ASCO 2025 (Korea Biomedical Review) - "Daehwa Pharm will present phase 3 results of Liporaxel Sol. in breast cancer at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO)....The presentation will focus on results from a multinational, multicenter, phase 3 trial in patients with recurrent or metastatic HER2-negative breast cancer."

P3 data • HER2 Negative Breast Cancer

Daehwa Pharm eyes China, Europe as oral chemo matches IV paclitaxel in phase 2/3 breast cancer trial (Korea Biomedical Review) - P2/3 | N=549 | OPTIMAL (NCT03315364) | Sponsor: Daehwa Pharmaceutical Co., Ltd | "Results from a phase 2/3 study, released Wednesday, showed that Liporaxel matched the efficacy of injectable paclitaxel as a first-line treatment for recurrent or metastatic HER2-negative breast cancer...The 582-patient, multi-country trial met its primary endpoint, demonstrating non-inferiority in progression-free survival (PFS) in the per-protocol set (PPS) population. Median PFS was 10.02 months with Liporaxel versus 8.54 months for the IV formulation. Secondary endpoints—including overall survival (OS), objective response rate (ORR), disease control rate (DCR), time to treatment failure (TTF), and quality of life (EQ-5D-3L)—also showed a non-inferior trend. The company plans to submit label expansion applications in Korea and China within the first half of the year, with Haihe Biopharma leading the process in China."

China filing • Korea filing • P2/3 data • Breast Cancer • HER2 Negative Breast Cancer

An open-label, multicenter, randomized, non-inferior Phase III trial comparing the efficacy and safety of paclitaxel oral solution (RMX3001DHP107) versus paclitaxel injection (Taxol) in second-line treatment of patients with advanced gastric cancer (Haihe Biopharma Press Release) - P3 | N=400 | CTR20190050 | Sponsor: Daehwa Pharmaceutical Co., Ltd. | "Median progression-free survival assessed by BIRC was 3.02 months (95% confidence interval [CI]: 2.69, 3.71) in the oral group and 2.89 months (95% CI: 2.53, 3.48) in the injection group, demonstrating non-inferiority conclusion (HR 0.894, 95% CI: 0.719, 1.112, p=0.311). Median overall survival (as of February 15, 2023) was 9.13 months (95% CI: 7.72, 10.97) in the oral group and 6.54 months (95% CI: 5.75, 7.26) in the injection group, showing superiority with an absolute 2.59-month survival improvement (HR 0.770, 95.5% CI: 0.635, 0.934, p=0.006). Paclitaxel oral solution was clinically manageable."

P3 data • Gastric Cancer

Daehwa Pharm’s Liporaxel wins Chinese approval to treat gastric cancer (Korea Biomedical Review) - "Daehwa Pharm...announced on Thursday that it has received marketing authorization from China's National Medical Products Administration (NMPA) for Liporaxel Sol. (Liporaxel), an oral paclitaxel for the treatment of gastric cancer....Liporaxel eliminates the need for pre-treatment and the three-hour dosing time associated with conventional paclitaxel intravenous (IV) therapy. Clinical trials have demonstrated improved outcomes for gastric cancer patients using Liporaxel compared to IV therapy, particularly regarding hair loss and peripheral neuropathy....The company said its ongoing phase 3 breast cancer MRCT study in Korea, China, and three countries in Eastern Europe is expected to be completed by the end of 2024. Then, the company will be able to submit additional indication applications in Korea and China in 2025."

China approval • China filing • Korea filing • Trial completion date • Breast Cancer • Gastric Cancer

Food Effect on Pharmacokinetics and Safety of DHP107 (Liporaxel®) FEEL Study (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: Daehwa Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed

Metastases • Trial completion • Breast Cancer • Head and Neck Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

OPTIMAL: Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy (clinicaltrials.gov) - P2/3 | N=549 | Active, not recruiting | Sponsor: Daehwa Pharmaceutical Co., Ltd. | Trial completion date: Mar 2024 ➔ Dec 2025

Metastases • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

Paclitaxel oral solution versus paclitaxel injection as second-line therapy in advanced gastric cancer: A randomized, open-label, non-inferiority phase 3 trial. (ASCO 2024) - "Safer and more convenient paclitaxel oral solution (Liporaxel), the world's first oral formulation, has been initially approved in Korea for treatment of gastric cancer. The study showed statistical non-inferiority of paclitaxel oral solution in PFS and statistically significant and clinically meaningful improvement in OS as compared to paclitaxel IV, with clinically manageable safety profile, supporting paclitaxel oral solution as second-line treatment option for patients with gastric cancer."

Clinical • Head-to-Head • Metastases • P3 data • Anemia • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • Immunology • Oncology • Pain • Solid Tumor

GIST Oral Paclitaxel(Liporaxel) (clinicaltrials.gov) - P2 | N=28 | Not yet recruiting | Sponsor: Asan Medical Center

New P2 trial • Gastrointestinal Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Oncology • Sarcoma

Daehwa Pharm's Liporaxel Sol. wins orphan drug designation in Europe (Korea Biomedical Review) - "Daehwa Pharm, a Kosdaq-listed drugmaker, said Friday it received orphan drug designation (ODD) from the European Medicines Agency (EMA) for Liporaxel Solution, an oral paclitaxel, for the second-line treatment of gastric cancer on Feb. 26. Daehwa explained that the orphan drug designation for Liporaxel Solution will allow the company to receive benefits, such as a shorter review period for new drug applications in Europe, reduced fees and taxes for marketing authorization applications, and exclusivity for 10 years after approval."

Orphan drug • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

OPERA: Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=72 | Completed | Sponsor: Daehwa Pharmaceutical Co., Ltd. | Unknown status ➔ Completed

Metastases • Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • HER-2