Shaanxi Aoxing Pharmaceutical Co., Ltd.

SAN FRANCISCO, June 15, 2023 /PRNewswire/ -- Biostar Pharma, Inc. (hereinafter referred to as "Biostar"), 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, after having in-depth discussions with the FDA through pre-IND meetings, the FDA has approved the IND of a phase 2/3 clinical trial with seamless protocol design for the company's core product utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Designated as BG01-2202, this trial is a multi-national, phase 2/3, open-label, randomized, controlled clinical study of utidelone injectable (UTD1) versus docetaxel. The study is going to be conducted at about 50 sites in about 10 countries and regions across US, Europe and Asia -Pacific. About 760 patients are planned to be enrolled, 90 for phase 2 with ORR (objective response rate) as the primary endpoint and 670 for phase 3 with OS (overall survival) as the primary endpoint and PFS (progression free survival), ORR, etc. as the secondary endpoints. Dr. Li Tang, Chairman of Biostar Pharma commented: "This is an important milestone for global development of utidelone injectable -- an innovative anti-cancer drug and new generation epothilone analogue. We are fully committed to advancing this pivotal multi-national study and also willing to partner with global pharmaceutical companies to bring this product to market around the world to benefit more patients". This study was warranted by a previous open-label, multi-center phase 2 trial conducted in China (NCT03693547) of utidelone as single-agent to treat patients with advanced NSCLC who had received at least two prior systemic regimens including platinum-containing chemotherapy or targeted therapy, which demonstrated promising clinical efficacy and manageable safety profile with outcomes of 19.0% ORR, 81.0% DCR (disease control rate), 4.37 months of median PFS and 71% of 12-month OS rate. The median OS was not reached by the cut-off date. The results were selected by 2022 ELCC (European Lung Cancer Congress) as poster presentation. A phase 3 study to evaluate utidelone versus docetaxel in locally advanced or metastatic NSCLC patients that have failed chemotherapy with a platinum-containing regimen has also been initiated and being in progress now in China. Unmet Medical Need Lung cancer remains the leading cause of cancer death worldwide [1]. NSCLC accounts for about 85% of lung cancer cases [2,3] and more than 75% of patients with lung cancer are diagnosed with locally advanced or stage IV disease [4]. Although currently targeted therapies and/or immunotherapies are commonly used for advanced NSCLC, limitations are obvious. Many patients either do not have a targetable driver gene alteration or are not suitable for immunotherapy [5,6]. Besides, acquired resistance to targeted- and immune-therapy is a substantial problem. In this case, chemotherapy, such as platinum- and taxane-based regimens, remains the fundamental treatment. However, acquired resistance to standard chemotherapies still presents challenges, which may limit their efficacy [7,8]. There is a huge unmet clinical need for alternative chemotherapeutic agents that can overcome, or are less susceptible to, drug resistance and have clinical efficacy in heavily pretreated patients. About Utidelone Being derived from Biostar's synthetic biology technology platform, utidelone is a genetically engineered best-in-class epothilone analog, which is a class of microtubule-targeting agent that has differential mechanisms of action from taxanes and is developed to overcome drug resistance. Utidelone injectable 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. Relevant study results were twice selected for oral presentations at ASCO annual meetings and invited to publish in Lancet Oncology and Annals of Oncology. 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 [email protected] on partnering with us. References [1] Sung H, Ferlay J, Siegal RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-249. . [2] Howlader N, Forjaz G, Mooradian MJ, Meza R, Kong CY, Cronin KA, et al. The effect of advances in lung-cancer treatment on population mortality. N Engl J Med. 2020;383:640-649. . [3] American Cancer Society. About lung cancer. 2022. Available at: . Accessed March 2023. [4] Surveillance, Epidemiology, and End Results. SEER registry data, 2011 to 2017. Available at: . Accessed March 2023. [5] NCCN. Clinical practice guidelines in oncology. Non-small cell lung cancer. V2.2023. Available at: . Accessed March 2023. [6] Chinese Association for Clinical Oncologists, Medical Oncology Branch of Chinese International Exchange and Promotion Association for Medical and Healthcare. Clinical practice guideline for stage IV primary lung cancer in China (2023 edition) [In Chinese]. Chin J Oncol. 2023 Jan;45(1):1-30. . [7] Hardin E, Shum E, Singh AP, Perez-Soler R and Cheng H. Emerging treatment using tubulin inhibitors in advanced non-small cell lung cancer. Expert Opin Pharmacother. 2017 May;18(7):701-716. . [8] Sève P and Dumontet C. Chemoresistance in non-small cell lung cancer. Curr Med Chem Anticancer Agents. 2005 Jan;5(1):73-88. SOURCE Biostar Pharma, Inc.

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.

DUBLIN--( BUSINESS WIRE )--The "Global Respiratory Partnering 2010-2022: Deal Trends, Players and Financials" report has been added to ResearchAndMarkets.com's offering. The Global Respiratory Partnering 2010 to 2022 report provides comprehensive access to available deals and contract documents for over 1000 respiratory deals. Most of the deals included within the report occur when a licensee obtains a right or an option right to license a licensor's product or technology. More often these days these deals tend to be multi-component including both a collaborative R&D and a commercialization of outcomes element. The report takes readers through the comprehensive Respiratory disease deal trends, key players and top deal values allowing the understanding of how, why and under what terms companies are currently entering Respiratory deals. The report presents financial deal terms values for Respiratory deals, where available listing by overall headline values, upfront payments, milestones and royalties enabling readers to analyse and benchmark the value of current deals. The initial chapters of this report provide an orientation of Respiratory dealmaking trends. Chapter 1 provides an introduction to the report. Chapter 2 provides an overview of the trends in Respiratory dealmaking since 2010 covering trends by year, deal type, stage of development, technology type and therapeutic indication. Chapter 3 includes an analysis of financial deal terms covering headline value, upfront payment, milestone payments and royalty rates. Chapter 4 provides a review of the leading Respiratory deals since 2010. Deals are listed by headline value. The chapter includes the top 25 most active Respiratory dealmakers, together with a full listing of deals to which they are a party. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 5 provides comprehensive access to Respiratory deals since 2010 where a deal contract is available, providing the user with direct access to contracts as filed with the SEC regulatory authorities. Each deal title links via Weblink to an online version of the deal record contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive directory of all Respiratory partnering deals by specific Respiratory target announced since 2010. The chapter is organized by specific Respiratory therapeutic target. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. In addition, a comprehensive appendix is provided with each report of all Respiratory partnering deals signed and announced since 2010. The appendices are organized by company A-Z, stage of development at signing, deal type (collaborative R&D, co-promotion, licensing etc) and technology type. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. The report also includes numerous tables and figures that illustrate the trends and activities in Respiratory partnering and dealmaking since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of Respiratory technologies and products. Report scope Global Respiratory Partnering 2010 to 2022 includes: Trends in Respiratory dealmaking in the biopharma industry since 2010 Access to headline, upfront, milestone and royalty data Access to hundreds of Respiratory deal contract documents Comprehensive access to over 1000 Respiratory deal records The leading Respiratory deals by value since 2010 Most active Respiratory dealmakers since 2010 Analyzing actual contract agreements allows assessment of the following: What are the precise rights granted or optioned? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are the sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Key Topics Covered: Executive Summary Chapter 1 - Introduction Chapter 2 - Trends in Respiratory dealmaking 2.1. Introduction 2.2. Respiratory partnering over the years 2.3. Respiratory partnering by deal type 2.4. Respiratory partnering by industry sector 2.5. Respiratory partnering by stage of development 2.6. Respiratory partnering by technology type 2.7. Respiratory partnering by therapeutic indication Chapter 3 -Financial deal terms for Respiratory partnering 3.1. Introduction 3.2. Disclosed financials terms for Respiratory partnering 3.3. Respiratory partnering headline values 3.4. Respiratory deal upfront payments 3.5. Respiratory deal milestone payments 3.6. Respiratory royalty rates Chapter 4 - Leading Respiratory deals and dealmakers 4.1. Introduction 4.2. Most active in Respiratory partnering 4.3. List of most active dealmakers in Respiratory 4.4. Top Respiratory deals by value Chapter 5 - Respiratory contract document directory 5.1. Introduction 5.2. Respiratory partnering deals where contract document available Chapter 6 - Respiratory dealmaking by therapeutic target 6.1. Introduction 6.2. Deals by Respiratory therapeutic target Appendices Appendix 1 - Directory of Respiratory deals by company A-Z 2010 to 2022 Appendix 2 - Directory of Respiratory deals by deal type 2010 to 2022 Appendix 3 - Directory of Respiratory deals by stage of development 2010 to 2022 Appendix 4 - Directory of Respiratory deals by technology type 2010 to 2022 Companies Mentioned Alnylam Pharmaceuticals Vortran Medical Sichuan University Lung and Blood Institute Food and Drug Administration (FDA) Bill and Melinda Gates Foundation Zhejiang Medicine Jubilant DraxImage Enzyvant Science Altavant Sciences Biostar Pharmaceuticals Scholar Rock Monopar Therapeutics Wockhardt Innovare Celularity Highmark Blue Shield Highmark Health Glenmark Pharmaceuticals 4D Pharma BESPharma IR Pharma SI Pharmaceuticals Wal-Mart Sanovas Amyndas Pharmaceuticals Tunitas Therapeutics Innovata HK Medidata Solutions Advocate Health Care Innovate UK Foundation for Sarcoidosis Research Simulations Plus Innovative Genomics Initiative (IGI) Innovative Medicines Initiative (IMI) Laboratory Corporation of America Novavax Dynavax Technologies Pharmaxis Scarab Genomics Punjab Province For more information about this report visit https://www.researchandmarkets.com/r/tub168