Albipagrastim alfa

“天下大势，分久必合，合久必分”——摘自《 三国演义·第一回 》据药渡数据库数据，2023年中国制药企业共达成药物交易（合作、许可）项目222个，其中国内转国内118个，国内转国外104个。相比往年，交易数量逐年走高，反映着我国创新药项目交易的持续火热。随着交易项目逐渐增多，有的合作方浓情蜜意携手走到最后，共同将药物顺利推上市，也有的合作方则走到了“分手”的路口。随着外部环境的变化、企业内部战略的调整，近年来不断有BD项目合作终止的新闻传出。2023年2月，创新药企诺诚健华和美国渤健终止BTK抑制剂奥布替尼在多发性硬化症领域的全球独家权利以及除中国以外区域内的某些自身免疫性疾病领域的独家权利合作和许可协议，退还商业化权益。此外，四川科伦博泰的两项临床前ADC、基石药业的PD-L1单抗舒格利单抗及抗PD-1单抗Nofazinlimab、加科思的SHP2抑制剂、凌科药业的JAK1抑制剂，以及天境生物的来佐利单抗等多个国内创新药的海外开发及商业化权益接连被退回。01未知即是机遇创新药的交易合作，本质上是一种创新药企与Big Pharma优势互补、资源互换的双赢合作。显然，离开创新药企的Big Pharma可以更容易从这段关系中抽身，继续寻找更适合自己的“下一任”。而“分手”之后，创新药企业的前途命运则往往令人担忧。创新药企是否有资金继续推动产品开发？收回权益的药物本身是否仍具有开发价值及成功上市的可能性？是否有实力完成产品上市后的商业化运营？这些问题都是横亘在创新药企们面前的问题，也最终决定了这场“分手”是危机还是机遇。此前，百济神州和诺华友好分手，收回了替雷利珠单抗的海外权益，“对于这件事，百济神州高管的态度都是一致的‘兴奋而高兴’”——百济神州总裁、首席运营官兼中国区总经理吴晓滨表示，一方面百济已具备推动海外商业化的能力，另一方面，由于不再受限于合作方的审定程序，开发速度将大大提升。可见“失恋”不总是令人悲伤的，也有嗅到自由的空气，准备大展拳脚的创新药企们。近日，我们注意到一起国内合作终止的新闻公告。2月24日，迈威生物发布公告称，经友好协商，公司及全资子公司江苏泰康生物医药有限公司分别与扬子江药业集团有限公司全资子公司江苏海博生物制药有限公司就8MW0511和9MW1111项目签署《协商解除协议》。协议解除后，迈威生物将收回该两款产品在中国大陆地区内的开发、生产及商业化权益。迈威生物的产品权益收回，是典型的“一个人精彩”的分手故事。在公告中，迈威生物预计本次项目终止合作不会影响在研药品的研发和商业化进度，现有业务现金流充裕，将不会对公司生产经营及财务状况产生重大影响。也就是说，迈威生物有足够的能力推动产品的开发；其次，8MW0511已经在CDE递交上市申请，并得到了受理，临床开发压力远低于出海创新药的海外临床开发压力。02产品在，江山在产品开发成功率及商业化前景的预期往往会随时间发生变化。收回权益的药物本身是否仍具有开发价值及成功上市的可能性？8MW0511是注射用重组（酵母分泌型）人血清白蛋白-人粒细胞集落刺激因子（I）融合蛋白，属于全新结构的治疗用生物制品Ⅰ类，目前处于上市审评中，用于成年非髓性恶性肿瘤患者在接受容易引起发热性中性粒细胞减少症的骨髓抑制性抗癌药物治疗时，降低以发热性中性粒细胞减少症为表现的感染发生率。另一个项目9MW1111是一种重组人源化抗PD-1单克隆抗体注射液。两款产品在多种肿瘤领域的应用潜力，为其市场前景提供了想象空间。8MW0511可以应用于包括肺癌、乳腺癌、尿路上皮癌、宫颈癌等各大肿瘤领域患者的治疗；K药在美国已经获批超过40个适应症，9MW1111作为PD-1抑制剂，在广泛的肿瘤适应症中具有潜在的应用价值。据IARC的数据，2020年中国新发癌症457万，占全球23.7%，位居第一，中国癌症死亡人数300万人，占全球癌症死亡总人数的30%。随着人口老龄化加剧及创新疗法的引入和仿制药进入市场，中国肿瘤药物市场规模将持续扩容。据了解，鉴于迈威生物的PD-1项目处于临床早期，公司更加期待给未来自己的肿瘤免疫（IO）联合ADC（抗体偶联）疗法提供更多可能的选择。产品差异化设计带来的有效性、安全性及成本优势，无疑提升了8MW0511的市场竞争力。8MW0511分子为白蛋白融合的G-CSF，长期使用有效性好，安全可控，无PEG蓄积风险。8MW0511的III期临床试验结果显示，无论是化疗第1-4周期的4级中性粒细胞减少发生率、发生4级中性粒细胞减少的持续时间，还是发热性中性粒细胞减少症的发生率，8MW0511组均优于PEG-GCSF阳性对照组。总体安全性与阳性对照组相似，人体用药安全可控，耐受性较好。另一方面，相比PEG化的长效G-CSF，8MW0511采用酵母表达系统进行生产，制备过程避免了复杂的PEG化学修饰反应，生产工艺简单，具有生产成本优势。8MW0511剂型为冻干粉针，有效期长，对运输储存更加友好。8MW0511上市在望，开发成功率毋庸置疑，产品的市场潜力和竞争优势仍在。收回商业化权益后，独享成功果实，不香吗？03商业化？放着我来对于即将上市的产品，迈威生物是否有实力完成其商业化运营是尤被关切的问题。毕竟2021年3月达成两个项目合作时，迈威生物尚未建立商业化团队。今时不同往日，迈威生物目前已经拥有两款上市产品——君迈康®（阿达木单抗注射液）和迈利舒®（地舒单抗注射液，规格为60mg/支，已获批用于骨折高风险的绝经后妇女的骨质疏松症），建立了自己的医学、准入和营销团队，已经覆盖自身免疫病、代谢和肿瘤领域，组织框架完整。据悉，迈威生物正在重点加强建设肿瘤领域的销售团队，预计效率较高，成本可控，公司也需要更多可运营的商业化产品。可见，迈威生物已经摩拳擦掌，准备好迎接8MW0511的上市。不仅如此，迈威生物对这两款产品的未来规划，似乎在回应市场的担忧：迈威生物不仅能稳稳接住产品的商业化运营，甚至能独自玩出更多花来！权益收回后，为迈威生物产品布局和营销模式有了更多可能性。纵览迈威生物研发管线，会发现肿瘤药物占据相当比重，对肿瘤领域的重视程度可见一斑。根据迈威生物2月24日的公告信息，公司考虑到该两款产品均为肿瘤领域用药，未来或可与自身其他产品协同销售或开发联合疗法。同时，作为创新药，在核心医院的准入和定价方面，具备一定优势，进一步提升了可商业化空间。在产品开发策略方面，未来可配合迈威生物的抗肿瘤药物开发联合疗法。公告中显示：8MW0511可以广泛应用于包括肺癌、乳腺癌、尿路上皮癌、宫颈癌等各大肿瘤领域患者，与公司即将上市的适用于实体肿瘤骨转移领域及骨巨细胞瘤适应症的地舒单抗（规格为120mg/支）有很好的协同效应，且针对未来上市的ADC产品如9MW2821等开发联合疗法，可进一步丰富产品管线，扩展产品生命周期。在产品营销策略方面，通过8MW0511提前建立肿瘤营销网络，助力未来肿瘤领域产品推广，特别是迈威生物重点布局的ADC产品。8MW0511覆盖肿瘤适应症范围广，可在多种肿瘤中同步做好商业化体系布局，使后续产品上市后快速实现医院准入和销售增长。此外，开发的联合疗法可与单药形成互补的产品矩阵，全方位满足临床用药需求，无疑会提升临床推广的效率。可见，迈威生物不仅在团队建设上已经为产品上市做好了准备，也对未来的研发和商业化策略做好了谋篇布局，充分发挥了产品的优势。药企们的“分手”从来都不是意气用事，而是深思熟虑。小结当前看来，迈威生物两款产品仍具有乐观的商业化前景和进一步开发的潜力，权益的回收于迈威生物而言助益颇多，迈威生物正信心满满，积极备战8MW0511的商业化。总体而言，这次权益收回，对迈威生物来说既是挑战也是机遇。若应对得当，将赢得更多、更长远的收益。让我们一起期待开始独当一面的迈威生物如何完成华丽转身吧。最后，提出一点我们的思考。随着自身实力提升、自家产品临近上市，创新药企们的研发和商业化策略也在做出相应调整。由合作走向独立，迈威生物及一些近段时间发生的“分手”事件，或许能为处于转型阶段的中国创新药企们提供新的角度。尤其是在行业形势瞬息万变的当下，建立自由的研产销一体全链路体系，避免掣肘于第三方的不确定性，适当增加前期成本来换取扩大的长期收益，似乎也是一种选择。盘点：2023年CDE发布药品注册指导原则及法规全景图国内首个「十亿美元分子」诞生记：从零到一→同类最佳→年销售额破十亿美元……鼻腔药物递送全揭秘，优势与挑战知多少？

SHANGHAI, Dec. 19, 2023 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that the new drug application of its recombinant (yeast-secreted) human serum albumin-human granulocyte colony-stimulating factor (I) fusion protein for injection (R&D code: 8MW0511) has been accepted by the National Medical Products Administration (NMPA) for use in adult patients with non-myeloid malignant neoplasms to reduce the incidence of infections manifested by febrile neutropenia when receiving myelosuppressive anticancer drugs that are susceptible to febrile neutropenia. 8MW0511, a Class 1 therapeutic biological product, is a new generation of long-acting G-CSF (modified cytokine with high activity) with independent intellectual property rights owned by Mabwell. 8MW0511 is produced by fusing the N-terminus of the modified G-CSF mutant gene with the C-terminus of human serum albumin with gene fusion technology. It significantly inhibits the G-CSF receptor-mediated clearance pathway, which prolongs the half-life period, reduces the frequency of drug administration, and improves the treatment compliance in clinical use. 8MW0511 is produced by yeast expression system, which brings better homogeneity, simplifies production process, and is expected to reduce the cost of production by avoiding the PEG modification reactions. The results of the Phase III clinical study of 8MW0511 presented at the European Society for Medical Oncology (ESMO) in 2023 showed that 8MW0511 was clinically effective, non-inferior to the positive control, PEG-rhG-CSF (Jinyouli), and improved the incidence and duration of Grade 4 neutropenia, especially in cycle 2-3 where the incidence of Grade 4 neutropenia was significantly lower than that of the positive control group. The overall safety profile was similar to that of the positive control group, which indicates manageable safety profile and good tolerance in humans. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 14 pipeline products in different R&D stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 2 products have been approved and commercialized, 2 product has been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and several provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base located in Shanghai is under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell