Multicenter randomized double blind phase III clinical trial comparing safety and efficacy of BCD-022 (CJSC BIOCAD, Russia) used with paclitaxel to HerceptinÂ® (F. Hoffmann-La Roche Ltd, Switzerland) used with paclitaxel in the first-line treatment of HER2-positive metastatic breast cancer patients.

开始日期2014-07-02

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项与曲妥珠单抗生物类似药(Biocad Medical, Inc.) 相关的文献（医药）

2022-12-01·BMC cancer2区 · 医学

Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-021 with reference bevacizumab

2区 · 医学

ArticleOA

作者: Matrosova, Marina P ; Kryukov, Fedor ; Shustova, Mariya S ; Adamchuk, Grigoriy A ; Shelepen, Konstantin G ; Kalloli, Mahesh ; Fadeeva, Natalya V ; Nagarkar, Rajnish ; Zhuravleva, Daria ; Voevodin, Georgiy D ; Roy, Bodhisatta ; Stroyakovskiy, Daniil L

Abstract:

Background:

BCD-021 is a bevacizumab biosimilar which was shown to be equivalent to reference bevacizumab in a wide panel of physicochemical studies as well as preclinical studies in vitro and in vivo. International multicenter phase III clinical trial was conducted to compare efficacy and safety of BCD-021 and reference bevacizumab in combination with paclitaxel and carboplatin in a first-line treatment of inoperable or advanced non-squamous non-small-cell lung cancer (NSCLC).

Methods:

Patients with no previous treatment for advanced non-squamous NSCLC were randomly assigned 3:2 to BCD-021 or reference bevacizumab and were treated with bevacizumab + paclitaxel + carboplatin. Therapy continued for 6 cycles (every 3 weeks), until progression of the disease or unbearable toxicity. The primary study endpoint was the overall response rate. The study goal was to prove the equivalent efficacy of BCD-021 and reference bevacizumab. Equivalence margins for 95% CI for the difference in the overall response rates were set at [-18%; 18%], for 90% CI for the ratio of overall response rate were set at [67%; 150%].

Results:

In total 357 patients were enrolled in the study, 212 in the BCD-021 group and 145 in the reference bevacizumab group. The ORR was 34.63% in the BCD-022 group and 33.82% in the reference bevacizumab group. Limits of 95% CI for the difference in overall response rates between the groups were [-9.47%; 11.09%]. Limits of 90% CI for the ratio of overall response rate between the groups were [79.6%; 131.73%]. For both approaches CI lied within predetermined equivalence margins. Profile of adverse events (AEs) was similar between the groups (any AEs were reported in 86.89% of patients in BCD-021 group and 89.05% of patients in reference group). No unexpected adverse reactions were reported throughout the study. No statistically significant differences regarding anti-drug antibody occurrence rate was found between BCD-022 (n=4; 1.96%) and comparator (n=5; 3.65%). Both drug products showed low occurrence rate and short life of anti-bevacizumab antibodies. Pharmacokinetics assessment after 1st and 6th study drug injection also demonstrated equivalent PK parameters by all outcome measures.

Conclusions:

Thus, the results of this study demonstrated therapeutic equivalence of bevacizumab biosimilar BCD-021 and referent bevacizumab drug.

Trial registration:

The trial was registered with ClinicalTrials.gov (Study Number NCT01763645, date of registration 09/01/2013).

2022-11-02·Immunopharmacology and immunotoxicology

Trastuzumab biosimilars vs trastuzumab originator in the treatment of HER2-positive breast cancer: a systematic review and network meta-analysis

Review

作者: Dong, Mei ; Liu, Tong ; Jin, Yao ; Liu, Duo

AIM:

Breast cancer is the most frequently diagnosed cancer in women and ranks second among causes for cancer related death in women. Trastuzumab originator (Herceptin) is a monoclonal antibody used as a standard treatment for breast and metastatic gastric cancer when the cancer cells over-express human epidermal growth factor receptor type 2 (HER2). As the patent of Trastuzumab has now expired, biosimilars are moving into the market. It is still controversial to chose which trastuzumab biosimilar has the best treatment of HER2-positive breast cancer patients. We conducted this network meta-analysis to explore the best trastuzumab biosimilar in the treatment of HER2-positive breast cancer patients.

METHODS:

PubMed, Cochrane library databases, China National Knowledge infrastructure (CNKI) and WanFang database up to November 2021 were systematically searched. The following search terms were used: 'trastuzumab originator', and 'trastuzumab biosimilar'. No language restriction was imposed. The reference lists of all retrieved articles were also reviewed to identify additional articles missed by using these search terms.

RESULTS:

We got 10 studies to conduct network meta-analysis to evaluate efficacy and serious adverse reactions among various trastuzumab biosimilars and trastuzumab originator. The overall response rate (ORR) and pathological complete response (pCR) of SB3 were worse than trastuzumab originator significantly, while the ORR and pCR of other trastuzumab biosimilars had not yet reached statistical differences compared with each other. The cumulative ranking curve (SUCRA) probability indicated that the ORR from best to worst was CT-P6, Herceptin, HLX02, PF-05280014, R-TPR-016, BCD-022, MYL-1401O, SB3, and the pCR from best to worst was PF-05280014, CT-P6, Herceptin, ABP-980, SB3. The serious adverse events (SAEs) of CT-P6 were more than Herceptin and MYL-1401O significantly, while the SAEs of other trastuzumab biosimilars had not statistical differences. The SUCRA probability indicated that the SAEs from best to worst was MYL-1401O, Herceptin, PF-05280014, SB3, HLX02, BCD-22, CT-P6.

CONCLUSION:

There was no statistical difference in both ORR and pCR of various trastuzumab biosimilars and Herceptin except SB3. The ORR and pCR of SB3 were worse than Herceptin. Both CT-P6 and PF-05280014 are better in the overall curative effect, but CT-P6 had the highest serious adverse reactions when compared with others. The PF-05280014 might be a better trastuzumab biosimilar in the treatment of HER2-positive breast cancer patients.

2020-12-01·BMC cancer2区 · 医学

Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-022 with reference trastuzumab

2区 · 医学

ArticleOA

作者: Kulik, Sergey A ; Shelepen, Konstantin G ; Burdaeva, Olga N ; Srivastava, Kirti ; Khorinko, Andrey V ; Paltusova, Anastasia N ; Mukhametshina, Guzel Z ; Ivanov, Roman A ; Vikranth, Mummaneni ; Kryukov, Fedor ; Shustova, Mariya S ; Satheesh, Chiradoni Thugappa ; Alexeev, Sergey M

Abstract:

Background:

BCD-022 is a trastuzumab biosimilar which was shown to be equivalent to reference trastuzumab in a wide panel of physicochemical studies as well as preclinical studies in vitro and in vivo. International multicenter phase III clinical trial was conducted to comparatively assess efficacy and safety of BCD-022 and reference trastuzumab in combination with paclitaxel used as the therapy of metastatic HER2(+) breast cancer. Pharmacokinetics and immunogenicity were also studied.

Methods:

Patients with no previous treatment for metastatic HER2(+) breast cancer were randomly assigned 1:1 to BCD-022 or reference trastuzumab and were treated with trastuzumab + paclitaxel. Therapy continued for 6 cycles of therapy (every 3 weeks), until progression of the disease or unbearable toxicity. Primary study endpoint was overall response rate. Study goal was to prove equivalent efficacy of BCD-022 and reference trastuzumab. Equivalence margins for 95% CI for difference in overall response rates were set at [− 20%; 20%].

Results:

In total 225 patients were enrolled into the study, 115 in BCD-022 arm and 110 in reference trastuzumab arm. Overall response rate was 49.6% in BCD-022 arm and 43.6% in reference trastuzumab arm. Limits of 95% CI for difference of overall response rates between arms were [(− 8.05)-19.89%], thus, they lied within predetermined equivalence margins [− 20%; 20%]. Profile of adverse events was similar between groups (any AEs were reported in 93.81% of patients in BCD-022 arm and 94.55% of patients in reference arm). No unexpected adverse reactions were reported throughout the study. No statistically significant differences regarding antibody occurrence rate (either BAb or NAb) was found between BCD-022 (n = 3; 2.65%) and comparator (n = 4; 3.64%). Both drug products are characterized with low occurrence rate and short life of anti-trastuzumab antibodies. Pharmacokinetics assessment after 1st and 6th study drug injection also demonstrated equivalent PK parameters by all outcome measures: AUC0–504, Сmах, Тmax, T1/2. Analysis of Ctrough did not reveal any significant inter-group differences as well.

Conclusions:

Thus, results of this study have demonstrated therapeutic equivalence of trastuzumab biosimilar BCD-022 and referent trastuzumab drug.

Trial registration:

The trial was registered with ClinicalTrials.gov (Study Number NCT01764022). The date of registration was January 9, 2013.

项与曲妥珠单抗生物类似药(Biocad Medical, Inc.) 相关的新闻（医药）

2024-08-23

·佰傲谷BioValley

全球足迹，复宏汉霖汉曲优®新增加拿大获批

2024年8月22日，复宏汉霖（2696.HK）宣布，公司商务合作伙伴Accord Healthcare Inc.（Intas子公司，“Accord”）于近日收到加拿大卫生部（Health Canada）通知，由复宏汉霖自主开发、生产的曲妥珠单抗生物类似药汉曲优®（美国商品名：HERCESSI™，欧洲商品名：Zercepac®）获批准于加拿大上市，商品名为Adheroza，用于早期乳腺癌、转移性乳腺癌及转移性胃癌的治疗。汉曲优®是在中国、欧盟、美国获批的“中国籍”单抗生物类似药，分别于2020年7月、2020年8月和2024年4月获得欧盟委员会、中国国家药品监督管理局（NMPA）和美国食品药品监督管理局（FDA）批准上市。截至目前，汉曲优®已成功于中国、美国、英国、法国、德国、瑞士、澳大利亚、芬兰、西班牙、阿根廷、沙特阿拉伯、新加坡、泰国、菲律宾等48个国家和地区获批上市，覆盖亚洲、欧洲、北美洲、拉丁美洲和大洋洲，惠及逾20万名患者。此次汉曲优®在加拿大获批主要基于复宏汉霖递交的全面的分析结果、临床前比对研究及临床比对研究数据。复宏汉霖针对汉曲优®（美国商品名：HERCESSI™, 欧洲商品名：Zercepac®）开展了一系列的头对头比对研究，包括质量对比研究、临床I期和国际多中心临床III期研究等。这些数据充分证明了汉曲优®与原研曲妥珠单抗在质量、安全性和有效性方面高度相似。汉曲优®的生产和质量控制环节遵循国际最高标准，其生产基地及配套的质量管理体系通过了由中国NMPA、欧洲药品管理局（EMA）、美国FDA、PIC/S成员印尼食品药品监督管理局（BPOM）和巴西国家卫生监督管理局（ANVISA）等药监机构及公司国际商业合作伙伴进行的多项实地核查及审计，获得中国、欧盟和美国GMP认证。复宏汉霖在上海建有三个生产基地，现有48,000升商业化产能，已实现全球产品常态化供应，全面覆盖中国、欧洲、东南亚、拉美、中东北非。公司亦持续推进产能扩增，有望进一步满足日益增长的全球市场需求。围绕汉曲优®，复宏汉霖前瞻性地开展了国际商业化布局，积极开拓海外市场，携手全球商业合作伙伴Accord、Abbott、Eurofarma和KGbio等国际一流的生物制药企业，全面布局美国、加拿大、欧洲以及众多新兴国家市场，覆盖全球约100个国家和地区。公司将继续与国际合作伙伴共同推进汉曲优®以及其他产品在国际市场的全球上市进程，惠及更广泛的患者群体。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，3款产品在国际获批上市，24项适应症获批，3个上市申请分别获中国药监局和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖50多个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）以及汉奈佳®（奈拉替尼），此外，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌和食管鳞状细胞癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。 Henlius Trastuzumab Receives Approval in Canada Shanghai, China, August 22, 2024 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the company's business partner, Accord Healthcare Inc. (an affiliate of Intas Pharmaceuticals, Ltd.), has received marketing approval (Notice of Compliance) from the Health Canada for HLX02 (trade name: HANQUYOU in China, HERCESSI™ in U.S., Zercepac® in Europe), a trastuzumab biosimilar self-developed and -manufactured by Henlius. The product has been approved under the trade name of Adheroza in Canada for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer. HLX02 (trade name: HANQUYOU in China, HERCESSI™ in the U.S., Zercepac® in Europe) is a China-developed monoclonal antibody (mAb) biosimilar approved in China, the European Union (EU) and United States (U.S.), with previous approvals for commercialization by the European Commission (EC), National Medical Products Administration (NMPA), and United States Food and Drug Administration (FDA) in July and August 2020 and April 2024, respectively. So far, HLX02 has been successfully approved in 48 countries and regions, including China, U.S., the United Kingdom, France, Germany, Switzerland, Australia, Finland, Spain, Brazil, Argentina, Saudi Arabia, and Thailand, covering Asia, Europe, Latin America, North America, and Oceania. To date, HLX02 has benefited more than 200,000 patients. HLX02 (trade name: HANQUYOU in China, HERCESSI™ in the U.S., Zercepac® in Europe) was granted approval by the Health Canada based on a comprehensive package of analytical, non-clinical and clinical study data submitted by Henlius. Henlius has conducted a series of head-to-head studies for HLX02, including comparative quality analytical studies, a phase 1 PK similarity study and a global multicentre phase 3 clinical study. The data demonstrated that HLX02 is highly similar to the reference product trastuzumab in terms of quality, safety, and efficacy. HLX02 (trade name: HANQUYOU in China, HERCESSI™ in the U.S., Zercepac® in Europe) has received recognition from global regulatory authorities for its longstanding commitment to maintaining manufacturing systems that comply with the highest quality standards. The manufacturing facilities for HLX02 has successfully passed the on-site inspections and audits conducted by the NMPA, European Medicines Agency (EMA), U.S. FDA, PIC/S Member Brazilian National Health Surveillance Agency (Portuguese: Agência Nacional de Vigilância Sanitária, “ANVISA”) and Indonesian Food and Drug Authority (Indonesian: Badan Pengawas Obat and Makanan, the“BPOM”), as well as Henlius’ international business partners, and have been GMP-certificated by China, the EU and U.S. regulatory agencies. The company has built 3 manufacturing facilities, and its current total commercial production capacity has reached 48,000 liters and maintains stable supply in China, Europe, Southeast Asia, Latin America, and Middle East and North African countries. The company is also continuing to expand its total commercial capacity to address the ever-increasing global market needs. Henlius has aggressively pursued international commercialization of HLX02 and is actively collaborating with global partners such as Accord, Abbott, Eurofarma, and KGbio to bring its therapeutics to patients in the U.S., Canada, Europe, and other emerging markets, covering about 100 countries and regions. As the product expands into more countries, Henlius will accelerate the delivery of high-quality, affordable, and innovative medicines to patients worldwide. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 3 marketing applications have been accepted for review in China and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. 联系方式媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

临床3期上市批准生物类似药

2024-03-23

·佰傲谷BioValley

华丽转身的复宏汉霖，靠的是什么？

近日，复宏汉霖发布了2023年度报告，营业总收入达到53.949亿元，同比增长67.8%，净利润达5.460亿元，首次实现了全年盈利。这一成绩主要源自公司核心产品陆续实现商业化销售后持续扩大销量，2023年产品销售收入合计约人民币45.535亿元，同比增长70.2%。去年7月，复宏汉霖发布了预告，预计今年上半年将实现由亏转盈，首次实现半年度盈利。如今，复宏汉霖在2023年交出了一份令人满意的答卷。全球商业化目前，复宏汉霖共有5款产品上市，包括CD20利妥昔单抗（汉利康）、HER2曲妥珠单抗（汉曲优）、TNF-α阿达木单抗（汉达远）、VEGF贝伐珠单抗（汉贝泰）和PD-1斯鲁利单抗（汉斯状），合计收入约人民币45.535亿元。其中，公司自营产品汉曲优和汉斯状分别实现全年销售收入人民币27.370亿元、11.198亿元，占据了所有产品营收的80%以上。汉利康是复宏汉霖的首款获批上市产品，也是国内首个获批的利妥昔单抗生物类似药，率先打破了进口药垄断格局。复宏汉霖非常重视海外市场，在海外已上市的第二款产品汉曲优早已成为国产生物类似药的代表。汉曲优原研产品为罗氏的赫赛汀，后者自1998年9月在美国获批上市后销售一直增长，并长期占据药物销售TOP10。然而，随着专利期的到来，2018年之后销售额逐渐下滑。汉曲优于2020年7月首次在欧盟获得批准，2020年8月在国内获批上市，成为国内首个曲妥珠单抗生物类似药，也是目前国内仅有2家药企获批上市的曲妥珠单抗生物类似药。在价格方面，汉曲优具有显著优势。赫赛汀在全球范围内价格昂贵，2018年时，美国售价为4500-5100美元/瓶（440毫克），欧盟售价为500-700美元/剂量（150毫克）。而汉曲优在国内定价为1688元/瓶（150mg）和837元/瓶（60mg），远低于赫赛汀的5500元/瓶（440mg）。目前，复宏汉霖的两款产品已全球上市，19个适应症获批，覆盖40个国家和地区，惠及逾56万名患者。然而，仅仅打破进口垄断并非复宏汉霖的唯一目标。公司的另一款生物类似药汉利康在国内原研药未获批准用于类风湿关节炎，但复宏汉霖通过瞄准适应症差异化“缺口”，于2022年3月获批该适应症，让汉利康在适应症覆盖面上超越了原研药，增加了成功进入被垄断市场的几率。此外，复宏汉霖还与Boston Oncology就汉利康在中东北非区域16个国家达成商业化合作，2023年汉利康的销售收入约为人民币5.405亿元。单月破亿的创新药复宏汉霖并不仅限于生物类似药，在创新药领域持续发力。自2018年以来，公司的研发开支已超过43亿元。2022年3月，复宏汉霖成功推出了首个创新产品H药汉斯状（斯鲁利单抗注射液），用于治疗微卫星高度不稳定（MSI-H）实体瘤。值得一提的是，汉斯状是国内第10款获批的PD-(L)1单抗。在国内PD-(L)1市场竞争已趋于饱和的情况下，汉斯状要想获得市场份额将面临相当大的挑战。汉斯状的首个适应症——MSI-H实体瘤适应症并不以癌种为限，覆盖了子宫内膜癌、结直肠癌、胃癌、肾细胞癌、卵巢癌等几十种实体瘤。同时，汉斯状也是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。截至2023年6月，汉斯状已完成国内27个省份的招标挂网，覆盖近千家医院的肺癌、消化道肿瘤等科室。公司还在不断丰富医疗保障，成功推动汉斯状进入上海、宁波、厦门、无锡、昆明等多个城市的定制型商业保险目录。2023年3月，汉斯状首次实现了国内单月销售额过亿。小结复宏汉霖致力于“生物类似药+创新药”的发展道路，通过生物类似药的商业化收入支持创新药的研发，取得了可观的产品营收规模，维持了稳定的产品现金流。截至目前，复宏汉霖的产品管线已覆盖超过50个分子，包括抗体、抗体偶联药物、融合蛋白、小分子药物等多种形式，并且在全球范围内开展了30多项临床试验。在未来，复宏汉霖将继续推进具有潜力的first/best-in-class产品，如HLX42、HLX43、HLX6018（创新抗GARP/TGF-β1单抗）、HLX99等，其中许多产品已获得突破性疗法认定和快速通道资格认定。复宏汉霖目标清晰明确，在缺乏专利保护的生物类似药领域，通过争取时间、抢占市场，持续赚取利润，并且致力于保持核心竞争力，离不开对创新药的不断研发。参考资料：1.https://mp.weixin.qq.com/s/IxBWxzlMwAU-31NB6OJ09Q本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处········

生物类似药财报上市批准专利到期

2022-12-05

·医药观澜

2022年license-out！这10多家中国公司研发的新药成功实现海外授权！

2022年即将迎来尾声。在创新药研发领域，在全球化合作的大趋势下，2022年中国创新药领域的授权合作保持活跃，并呈现出新的特点。本文将盘点分享10多个比较有代表性的“license-out”案例，这些公司在过去一年成功将新药或新技术实现海外授权。从疾病领域来看，这些实现海外授权的产品集中在抗肿瘤领域，其次是代谢、疼痛和自身免疫性疾病领域。从前沿技术和靶点角度来看，这些产品类型包括了单抗、双抗、CAR-T细胞疗法、抗体偶联药物以及靶向蛋白降解剂等等，涵盖靶点包括TROP2、AR、Claudin 18.2、BCMA、Siglec-15、IL-2等等。本文将结合公开资料分享部分比较有代表性的海外授权合作信息，供读者参阅授权产品：SIM0278作用机制：IL-2突变融合蛋白授权方：先声药业引进方：Almirall公司9月29日，先声药业和Almirall公司宣布，已就前者开发的自身免疫候选药物IL-2突变融合蛋白SIM0278签订独家授权协议。Almirall公司将获得在大中华区以外地区开发和商业化SIM0278所有适应症的独家权利，先声药业将收取1500万美元首付款以及至多4.92亿美元开发和商业里程碑付款。SIM0278是一种皮下给药Treg选择性白细胞介素2突变融合蛋白（IL-2 mu-Fc），即将进入临床阶段。它将携带特定突变的IL-2与抗体Fc端融合，显著延长了分子半衰期并提高受体特异性与亲和力，能够选择性活化Treg细胞，而不激活效应T细胞或NK细胞，从而达到恢复机体免疫平衡的作用，有望用于治疗多种自身免疫疾病。授权产品：JMKX002992作用机制：AR降解剂授权方：济民可信引进方：基因泰克8月18日，济民可信宣布，集团及旗下子公司上海济煜与罗氏（Roche）及旗下基因泰克（Genentech）达成独家许可协议，基因泰克获得上海济煜小分子创新研究院开发的口服雄激素受体（AR）降解剂JMKX002992在全球的开发及商业化独家权利。为此，基因泰克将支付6000万美元首付款，并在达到协议约定的里程碑时支付最高可达5.9亿美元的里程碑款项。JMKX002992是一款全新口服AR降解剂，对于对现有疗法耐药的前列腺癌患者具有治疗潜力。值得一提的是，根据罗氏新闻稿，这也是该公司及旗下基因泰克首次从中国创新药企获得在全球开发和商业化潜在药物的独家许可权利。授权产品：SYSA1801作用机制：抗Claudin 18.2抗体偶联药物授权方：石药集团引进方：Elevation Oncology7月28日，石药集团宣布，其附属公司石药巨石生物已与Elevation Oncology签订独家授权协议，石药巨石生物同意授予后者在大中华区以外地区开发及商业化抗Claudin 18.2抗体偶联药物（ADC）SYSA1801的独家权益。石药巨石生物将收取2700万美元的首付款，并有权收取最多1.48亿美元的潜在开发及监管里程碑付款，以及最多10.2亿美元的潜在销售里程碑付款。SYSA1801是一款靶向Claudin 18.2的ADC，能有效通过抗Claudin 18.2抗体靶向肿瘤细胞并发生内吞，将小分子毒素带入肿瘤细胞进而治疗肿瘤。该药早先已经获得美国FDA授予用于治疗胃癌（包括食道胃结合部癌症）及胰脏癌的孤儿药资格，并正在中国开展1期临床研究。授权产品：SKB-264等作用机制：靶向TROP2的ADC等授权方：科伦博泰引进方：默沙东7月26日，科伦药业控股子公司科伦博泰宣布，与默沙东（MSD）就一款用于治疗实体瘤的ADC产品达成合作及独家许可协议，有偿独家许可默沙东在全球范围内研发、生产与商业化该产品。双方还将对该款ADC产品的早期临床开发进行合作。默沙东将向科伦博泰支付3500万美元首付款、不超过9.01亿美元的各类里程碑付款及相应净销售额提成。今年早些时候（5月16日），科伦博泰就与默沙东签署协议，将靶向TROP2的ADC产品SKB-264有偿独家许可给默沙东进行大中华区以外的商业化开发。科伦博泰将分别于许可协议生效时、协议修正案签署后收到1700万美元付款和3000万美元付款，里程碑付款累计不超过13.63亿美元。根据科伦博泰公开资料，SKB-264目前正在开展针对多个瘤种的单药/联用的2期和3期临床试验，包括一项与抗PD-1单抗帕博利珠单抗联用治疗晚期实体瘤的国际多中心2期临床研究。授权产品：利拉鲁肽生物类似药作用机制：GLP-1受体激动剂授权方：华东医药引进方：Julphar公司6月23日，华东医药宣布其全资子公司杭州中美华东与Julphar公司达成合作，将其开发的利拉鲁肽注射液生物类似药针对糖尿病和减肥两个适应症，在中东和北非地区17个国家的开发、生产及商业化权益授予Julphar公司。利拉鲁肽是人胰高血糖素样肽-1（GLP-1）受体激动剂。在中国，华东医药已经向中国国家药监局（NMPA）递交了这款利拉鲁肽注射液的上市申请，针对糖尿病、肥胖或超重两大适应症。授权产品：利妥昔单抗生物类似药等作用机制：抗CD20单抗等授权方：复宏汉霖引进方：Eurofarma公司、雅培（Abbott）、Organon公司复宏汉霖在2022年至少已经达成3项海外授权合作，包括：1）5月11日，复宏汉霖宣布与Eurofarma公司签署许可协议，授予后者在16个拉美地区国家对利妥昔单抗生物类似药（汉利康）、曲妥珠单抗生物类似药（汉曲优）、贝伐珠单抗生物类似药（汉贝泰）三款产品进行开发、生产和商业化的权益。复宏汉霖将从此次交易中获得高达5050万美元的潜在收入；2）5月24日，复宏汉霖宣布与雅培公司签署许可协议，授予其在巴西对汉利康和汉曲优两款产品的商业化半独家权益。Abbott公司将支付首付款300万美元以及后续不超过140万美元的里程碑付款；3）6月13日，复宏汉霖宣布与Organon公司签署授权许可及供货协议，授予后者对帕妥珠单抗生物类似药HLX11、地舒单抗生物类似药HLX14两款产品除中国以外全球范围内的独家商业化权益。复宏汉霖将从中获得5.41亿美元的潜在收入。根据复宏汉霖公开资料，HLX11、HLX14两款产品目前均在开展国际多中心3期临床研究。授权产品：JMKX000623作用机制：Nav1.8阻滞剂授权方：济民可信引进方：Orion corporation公司5月6日，济民可信宣布旗下子公司上海济煜与Orion公司达成一项独家合作协议，后者将获得上海济煜自主研发的非阿片类镇痛新药JMKX000623大中华区以外的开发、生产及商业化权利。上海济煜将获得1500万欧元首付款以及相应的开发和商业化里程碑款项。JMKX000623是一款高选择性和高活性Nav1.8阻滞剂，通过阻滞钠离子内流而阻止痛觉发生和传递，有望开发治疗急性和慢性疼痛。该药已经于今年3月在中国获批临床，拟开发适应症为疼痛。授权产品：LM-302作用机制：靶向Claudin 18.2的ADC授权方：礼新医药引进方：Turning Point公司5月5日，礼新医药宣布与Turning Point公司达成一项独家授权协议，后者将作为独家合作伙伴获得礼新医药自主研发的靶向Claudin 18.2的ADC产品LM-302在全球除大中华区及韩国以外国家及地区的开发及商业化权益。礼新医药将获得2500万美元的首付款，研发里程碑付款1.95亿美元及后续商业化里程碑付款，总金额超过10亿美元。公开资料显示，LM-302已经在中国和美国获批1/2期临床试验，此前它已被FDA授予治疗胰腺癌、胃癌及胃食管交界部癌的孤儿药资格。值得注意的是，今年6月，百时美施贵宝（BMS）公司已经与Turning Point公司达成协议，将斥资超过40亿美元收购后者。授权产品：HBM7022作用机制：Claudin 18.2 x CD3双特异性抗体授权方：和铂医药引进方：阿斯利康4月7日，和铂医药宣布与阿斯利康（AstraZeneca）达成授权合作。阿斯利康将获得和铂医药开发的Claudin 18.2 x CD3双特异性抗体HBM7022的研发、注册、生产和商业化的全球独家许可，并负责该药临床前的进一步开发及商业化相关的所有费用。和铂医药将获得2500万美元的预付款和最高达3.25亿美元的里程碑付款。HBM7022是一款新型双抗，采用二价高亲和力抗Claudin 18.2和单价低亲和力抗CD3的结构，在保证高杀伤活性的同时，降低了产生细胞因子风暴的风险。临床前研究表明，该药不但对CLDN18.2阳性胃癌有较好的效用，还对胰腺癌和CLDN18.2突变的胃癌有很好的效用。授权产品：GFH009作用机制：CDK9抑制剂授权方：劲方医药引进方：SELLAS生命科学集团4月1日，劲方医药与SELLAS生命科学集团宣布达成独家授权协议，后者将作为独家合作伙伴获得劲方医药新一代高选择性CDK9小分子抑制剂GFH009注射剂在大中华区之外的全球开发和商业化权益。劲方医药将获得1000万美元首付款及技术转让费，以及基于不超过3个适应症开发、累计达4800万美元的开发里程碑付款，以及累计达9200万美元的销售里程碑付款。劲方医药已经在中美两地平行开展GFH009针对复发性/难治性恶性血液瘤患者的1期临床试验。临床前实验数据显示，该产品对CDK9蛋白的选择性抑制率超过其它CDK亚型100倍以上。SELLAS公司将针对儿童软组织肉瘤（包括尤因肉瘤和横纹肌肉瘤）患者开展一项GFH009单药1/2期篮式试验。授权产品：PRG-1801作用机制：靶向BCMA的CAR-T细胞治疗药物授权方：普瑞金生物引进方：CellPoint公司4月1日，普瑞金生物宣布与CellPoint公司达成授权合作，将其自主开发的靶向BCMA的CAR-T细胞注射液PRG-1801用于血液肿瘤适应症的欧美权益授予后者。普瑞金生物将获得超过2000万欧元的首付款以及各阶段里程碑付款。普瑞金生物公开资料显示，PRG-1801嵌合高亲和力和高特异性的重链可变结构域，具有良好的安全性和优效性。值得一提的是，2022年6月，CellPoint公司被Galapagos公司全资收购；9月，普瑞金生物宣布与Galapagos公司就PRG-1801项目在中国和印度以外市场的临床开发和商业化权益达成进一步合作。授权产品：BSI-060T作用机制：抗Siglec-15抗体授权方：博奥信生物引进方：Pyxis Oncology公司3月30日，博奥信生物（Biosion）宣布与Pyxis Oncology公司签订授权协议，后者将获得博奥信生物创新抗体BSI-060T除大中华区外的全球开发和商业化独家许可，博奥信生物将获得1000万美元的首付款，还将有资格收到总额高达2.225亿美元的里程碑付款。BSI-060T（现称PYX-106）是一种高亲和力的全人源抗 Siglec-15（S15）单抗，拟开发用于治疗多种实体瘤。它通过靶向M2巨噬细胞、S15诱导的骨髓细胞和S15阳性肿瘤，来阻断S15引起的免疫抑制。根据协议，Pyxis Oncology公司计划尽快在美国开展该产品的临床试验申报和1期临床试验，同时将有机会从博奥信引进围绕Siglec-15靶点的下一代产品权益。授权产品：艾贝格司亭α作用机制：长效粒细胞集落刺激因子授权方：亿一生物引进方：APOGEPHA公司2月28日，亿帆医药宣布其子公司亿一生物与APOGEPHA公司签订合作协议，后者将获得亿一生物开发的长效粒细胞集落刺激因子（G-CSF）艾贝格司亭α在德国的独家经销权。亿一生物将获得首付款40万美元、最高不超过100万美元开发里程碑付款及最高不超过3750万美元的销售里程碑付款。根据亿帆医药公开资料，艾贝格司亭α注射液拟用于治疗化疗致中性粒细胞减少症（CIN），该药已分别在中国、美国和欧盟递交上市申请并获得受理。授权产品：609A作用机制：抗PD-1单抗授权方：三生制药引进方：Syncromune公司1月4日，三生制药宣布旗下子公司三生国健签署授权协议，将其研发的抗PD-1单抗609A用于一种名为syncrovax的肿瘤免疫联合疗法的全球权益授权给Syncromune公司，三生国健将继续保有609A全球任何syncrovax疗法以外的权益。根据三生制药新闻稿介绍，syncrovax疗法为个性化的自体疫苗平台，致力于通过克服转移性癌症的免疫抑制特性，来解决当前系统免疫疗法的局限性，从而实现对多种实体瘤的治疗目的。除了上述药物，还有一些中国公司就自主研发的创新平台和技术达成海外授权合作。如：1月11日，驯鹿生物与信达生物联合宣布，授予Sana Biotechnology公司经临床验证的全人源BCMA CAR 结构的非独家商业权利，应用于Sana公司特定的体内基因治疗和体外低免疫细胞治疗产品开发；1月18日，和誉医药与礼来公司（Eli Lilly and Company）宣布，针对心脏代谢疾病等重大疾病中的未公开靶点，在新型小分子药物的发现、开发及潜在商业化领域开展合作，和誉医药将负责利用其专有的药物研发平台进一步开展小分子药物的发现和开发；3月2日，天演药业宣布与赛诺菲（Sanofi）达成一项研究合作与独家技术授权协议，使用安全抗体SAFEbody技术开发赛诺菲提供的新一代单抗与双抗的精准掩蔽型安全抗体；11月9日，英矽智能（Insilico Medicine）宣布，与赛诺菲达成战略研发合作。双方将利用英矽智能的人工智能平台Pharma.AI，针对高达6个新靶点开发候选药物；11月11日，和铂医药宣布其全资子公司诺纳生物与莫德纳（Moderna）签订授权及合作协议，将充分利用和铂医药专有的全人源重链抗体平台HCAb，研究及开发基因免疫疗法。除了上述案例，还有一些中国公司研发的新药和新技术也在2022年达成了授权合作，限于篇幅，本文不再一一介绍。我们很高兴看到，创新药研发领域不同形式、不同领域甚至跨学科的合作正在不断涌现，协同创新俨然已经成为行业的新常态。通过博采众长和创新的碰撞，新技术和新疗法正在以“加速度”的轨迹来到患者身边。希望这些新药后续开发进程顺利进行，早日造福全球患者！内容来源于网络，如有侵权，请联系删除。

细胞疗法引进/卖出免疫疗法

100 项与曲妥珠单抗生物类似药(Biocad Medical, Inc.) 相关的药物交易

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