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博志研新抗肿瘤新药BCM323口服溶液IND申请获CDE受理!

2022/02/15

2022年2月10日,上海博志研新药物技术有限公司(以下简称“博志研新”)新药项目BCM323口服溶液IND申请获得国家药品审评中心的受理(受理号:CXHL2200086),该品种主要用于多种实体瘤的治疗。

BCM323口服液项目介绍

BCM323口服溶液是一款全新的me-better抗肿瘤药物,注册分类2.2。其活性成分已在多个国家和地区上市,并被多个临床指南推荐为其适应症领域一线治疗的标准方案,同时国内临床权威专家在2021年发表了其用于治疗多种肿瘤的超说明书用药专家共识。该药的活性物质属于BCS Ⅱ类且具有pH依赖性,变异系数高、生物利用度低、给药剂量大,在临床中观察到严重和致命的副作用因此被FDA给予了黑框警告。

BCM323口服溶液采用了聚合物胶束增溶技术改善活性物质在胃肠道中的溶解性和渗透性,同时合理选择辅料,抑制P-糖蛋白的外排。比格犬体内数据表明,BCM323口服溶液的生物利用度提高近30倍。在摄入较低活性物质时,BCM323口服溶液既维持有效治疗效果,同时副作用降低,有望为肿瘤患者提供一个更加安全有效的治疗选择。

SOL ENHANCEDTM

聚合物胶束是当两亲性聚合物的浓度超过临界胶束浓度(critical micelle concentration, CMC)后自发形成的一种热力学稳定体系。

聚合物胶束具有独特的优势:

① 增大疏水性药物溶解度;

② 物理化学性质稳定;

③ 被动靶向作用,改善药物的生物分布,提高生物利用度、降低毒副作用;

④ 物理包封和化学连接药物,提高载药量,增强治疗效果;

⑤ 结构灵活,多功能化修饰实现药物的高效递送。

博志研新拥有国内领先的增溶递送技术平台(SOL ENHANCEDTM),掌握包括微粉化、复合物、包合物、固体分散体、脂质系统、微乳/自微乳、表面活性剂和聚合物胶束等增强药物溶解性,提高难溶性药物的生物利用度的技术。

The IND application of BociMed anti-tumor drug BCM323 oral solution was accepted by CDE!

10 February 2022, the IND application of the new drug project BCM323 oral solution of BociMed was accepted by the National Center for Drug Evaluation (acceptance number: CXHL2200086), mainly used for the treatment of various solid tumors.

BCM323 Oral Liquid

BCM323 oral solution is a new me-better anti-tumor drug, which is classified as 2.2. Its active pharmaceutical ingredients have been marketed in many countries and have been recommended by multiple clinical guidelines as the standard regimen for first-line treatment in the field of indications At the same time, domestic clinical authoritative experts published in 2021 that it is used for the treatment of many Expert consensus on off-label drug use in various tumors. The active pharmaceutical ingredient belongs to BCS II,which is pH-dependent. It has a high coefficient of variation, low bioavailability and large doses. Serious and fatal side effects were observed in clinical trials, so it was given a boxed warning by the FDA.

BCM323 oral solution adopts polymer micelle solubilization technology to improve the solubility and permeability of active pharmaceutical ingredient in the gastrointestinal tract, selects excipients reasonably to inhibit the efflux of P-glycoprotein. In vivo data in beagle dogs demonstrated a nearly 30-fold increase in the bioavailability of BCM323 oral solution. When ingesting lower active substances, BCM323 oral solution not only maintains effective therapeutic effect, but also reduces side effects, which is expected to provide a safer and more effective treatment option for tumor patients!

SOL ENHANCEDTM

Polymeric micelles are thermodynamically stable systems that spontaneously form when the concentration of amphiphilic polymers exceeds the critical micelle concentration .

Polymeric micelles have unique advantages:

① Increase the solubility of hydrophobic drugs;

② Stable physical and chemical properties;

③ Passive targeting, improve the biodistribution of drugs, improve bioavailability, and reduce toxic and side effects;

④ Physical encapsulation and chemical connection of drugs to increase drug loading and enhance therapeutic effect;

⑤ Flexible structure and multifunctional modification to achieve efficient drug delivery.

BociMed owns the leading solubilization and delivery technology platform(SOL ENHANCEDTM) in China, mastering the fields of micronization, complexes, inclusions, solid dispersions, lipid systems, microemulsions/self-emulsions, surfactants and polymer micelles, etc. The technology used to enhance the solubility of drugs and improve the bioavailability of poorly soluble drugs.

关于博志研新

博志研新是一家领先的药物递送技术平台型企业,专长复杂药物制剂(缓控释制剂、双层多层制剂、长效注射剂)、特殊药物制剂(口腔速溶制剂、贴剂、鼻喷剂、儿科制剂)、增溶药物制剂(喷雾干燥、纳米晶、自微乳、包合、胶束增溶)、高活药物制剂(HP DP)、生物递送技术(外泌体、脂质体)等。发展至今,博志研新拥有上海张江、上海临港2大中心及成都临床子公司,3大业务研发中心,助力客户完成高难度药物的全合成、工艺优化、处方前研究,及复杂制剂、特殊制剂、创新药制剂的研发与生产服务。

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