Paclitaxel/Encequidar mesylate

SAN FRANCISCO, March 21, 2024 /PRNewswire/ -- Biostar Pharma, Inc., the U.S. subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the development and commercialization of innovative oncology drugs, announced today that their key pipeline product UTD2 (utidelone capsule) had been granted an Orphan Drug Designation (ODD) by the FDA for the treatment of gastric cancer. An orphan drug is used to treat a rare disease that affects fewer than 200,000 patients in the US. Orphan drug development presents several major challenges including difficulties in patient recruitment, small market size and low return for the pharmaceutical companies. To encourage drug development for the benefit of rare disease patients, an ODD granted by the FDA provides many incentives such as tax relief on clinical trial costs, opportunity to apply for grants to support clinical trials, waiver of new drug application fee, acceleration for regulatory pathway, and the potential to receive 7 years of marketing exclusivity in the US market upon product approval. Utidelone is the only approved innovative microtubule inhibitor developed using synthetic biology technology. It has similar mechanism of action with that of taxanes while demonstrating multiple advantages, including better anti-tumor activity, broader anti-tumor spectrum, high oral bioavailability, better safety pro very low hematologic toxicity, not susceptible to P-glycoprotein and effective against multidrug-resistant tumors, and capability of crossing the blood-brain barrier for brain tumor treatment. In addition, its environmental-friendly fermentation production process also contrasts with paclitaxel. Development of oral formulation of microtubule inhibitors has been challenging due to susceptibility to P-glycoprotein-mediated efflux and low bioavailability. Oral taxanes such as Tesetaxel® and Oraxol® all failed in clinical trials because of safety problems, suggesting a huge unmet medical need. So far there is no approved oral microtubule inhibitors in the US and Europe. Biostar successfully developed utidelone capsule leveraging on its proprietary technology platform. Utidelone capsule has many advantages including improved administration convenience, enhanced patient compliance, reduced treatment cost, facilitation of long-term therapy and promotion of combination therapy. Gastric cancer, despite its low prevalence in the US, is an extremely serious global health problem due to its highly invasive and heterogeneous nature. In 2022, about 810,000 gastric cancer patients died worldwide, ranking fourth in the global mortality rate of malignant tumors [1]. In the U.S., according to the American Cancer Center, 26,890 new cases and 10,880 deaths of gastric cancer are expected in 2024. In addition, the five-year survival rate of gastric cancer in the U.S. is only 31.1%, indicating poor prognosis. Chemotherapy is the cornerstone therapy for gastric cancer and is widely used for major subtypes and various treatment lines. Chemotherapy combined with PD-1 has gradually become the first choice for the first-line treatment of advanced gastric cancer. The FDA granted ODD to UTD2 based on the promising data of a two-stage, multi-center phase 2 clinical study. For the first stage which has been completed, 15 advanced gastric cancer patients who received utidelone capsule monotherapy were evaluated for efficacy with an outcome of 3 PR (partial response) and 5 SD (stable disease). For the second stage, 11 patients with metastatic and/or unresectable HER2 negative gastric cancer who received the first-line treatment of utidelone plus sintilimab and oxaliplatin completed tumor assessment with an outcome of 8 PR and 3 SD, showing 100% clinical benefit rate (CBR)! Currently utidelone capsule's clinical studies are underway both in the U.S. and China. The preliminary data showed high bioavailability of 57% with low effective dose, wide therapeutic window, and a good safety profile. Biostar Pharma believes that utidelone capsule will show huge application potential and market space with its promising clinical performance and other advantages. [1] Source: Frost & Sullivan Analysis About Beijing Biostar Pharmaceuticals Co., Ltd. Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated biopharma company focusing on the development of first- and best-in-class innovative anti-cancer drugs with independent intellectual property through state-of-the-art technology platforms of combinatorial biosynthesis, microbial fermentation production and microbial drug formulation development. With an insight-driven strategy, experienced R&D teams, cGMP-compliant manufacturing facility and domestic commercialization capability, the company have built a balanced product pipeline, covering both lead product life-cycle expansion and early-stage projects development. Further information can be found on the company's website or by contacting our business development team at bd@biostar-pharma.com on partnering with us.

SAN FRANCISCO, June 12, 2023 /PRNewswire/ -- Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, is pleased to announce that the first patient has been enrolled today for a Phase 1 clinical study (BG02-2201; NCT05681000) of its proprietary oral formulation product of utidelone, UTD2 (utidelone capsule) in advanced solid tumor patients in the US. This study will be conducted at multiple clinical research centers including Sarah Cannon Research Institute (Florida Cancer Specialists & Research Institute), University of Southern California, Washington University School of Medicine in St. Louis, et al. Unmet Medical Need With the improvement of treatment regimen, the overall survival of cancer patients has increased significantly in the past years. Therefore, good patient compliance is an important factor for clinical efficacy in the long-term care of cancer patients. Chemotherapy, represented by microtubule inhibitors, remains the most common systemic treatment for cancer, However, most microtubule inhibitors are through I.V. administration, which may potentially cause allergic reactions and inconvenience. So far there have been barely oral dosage forms of microtubule inhibitors successfully developed due to low solubility and being a substrate of drug-resistant P-glycoprotein. Liporaxel is an oral taxane that has only been approved for marketing in South Korea, and its oral bioavailability was still quite low. Other oral dosage forms such as Tesetaxel and Oraxol have failed in clinical trials due to safety and other problems, suggesting a huge unmet medical need. Advantage for Oral Administration UTD2 is the world's first oral epothilone microtubule inhibitor. Utidelone has the advantage for oral formulation since it's not the substrate of P-glycoprotein. Pre-clinical studies of UTD2 demonstrated good PK and safety profiles and relatively high bioavailability. Compared with injections, utidelone capsules do not require the addition of organic solvents and surfactants. Thus, they may reduce the adverse events caused by intravenous administration, shorten the hospital stay of patients, improve administration convenience, enhance patient compliance and broaden the potential for combination therapy with other anti-cancer drugs. Dr. Li Tang, Chairman of Biostar Pharma said: "The first patient enrollment of UTD2 in the US clinical trial is an important step for our international development strategy. We are honored to have a number of well-known research institutions and investigators in the US to carry out the study. We are confident that this breakthrough product will provide more benefits for numerous cancer patients and bring about a substantial change to microtubule inhibitors administration. The company is fully committed to advancing this study in order to meet substantial clinical needs around the world." About UTD2 and Utidelone UTD2 is the oral formulation of utidelone (utidelone capsule), which is developed through the proprietary microbial drug formulation platform of Beijing Biostar Pharmaceuticals Co., Ltd. Utidelone is a genetically engineered microtubule inhibitor and its injectable dosage has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC). It is the only approved new molecular of microtubule inhibitor in the past 10 years around the world. Among all single agent or combination regimen of non-taxane chemotherapies, utidelone injectable is the only one to achieve both PFS and OS benefits for heavily pretreated MBC patients. It demonstrated several advantageous features, such as overcoming taxane-resistant, low hematological toxicity suitable for longer term exposure, ability to cross the blood-brain barrier that is able to prevent and treat tumor brain metastasis. The phase 3 study results of utidelone injectable were twice selected for oral presentations at ASCO annual meetings and invited to publish in Lancet Oncology and Annals of Oncology. It is also recommended by "2023 CSCO Guidelines for Diagnosis and Treatment of Breast Cancer" as Class I (category IA). Clinical studies for multiple indication expansion are in progress, including phase 3 trials for non-small-cell lung cancer and breast cancer neoadjuvant, respectively, as well as phase 2 trial for the first line treatment of advanced esophageal cancer and gastric cancer. About BG02-2201 Study BG02-2201 represents the "Phase I Clinical Study on the Tolerability of Utidelone Capsule in Patients with Advanced Solid Tumors" (NCT05681000), which is an open-label phase I dose escalation study and will be conducted at several clinical research centers in the United States. 16-28 patients with advanced solid tumors are expected to be enrolled. The primary objective is to evaluate the safety and tolerability of UTD2 to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). The secondary objectives are to evaluate the pharmacokinetic profile of UTD2 and to preliminarily assess the anti-tumor efficacy of UTD2 in advanced solid tumor patients. About Beijing Biostar Pharmaceuticals Co., Ltd. Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated biopharma company focusing on the developing of first- and best-in-class innovative anti-cancer drugs with independent intellectual property through state-of-the-art technology platforms of combinatorial biosynthesis, microbial fermentation production and microbial drug formulation development. With an insight-driven strategy, experienced R&D teams, cGMP-compliant manufacturing facility and domestic commercialization capability, the company have built a balanced product pipeline, covering both lead product life-cycle expansion and early-stage projects development. Further information can be found on the company's website or by contacting our business development team at [email protected] on partnering with us. SOURCE Biostar Pharma, Inc.