冲上云霄前的轰鸣
The roar before the launch
大家新年好！
在即将迎来2022年的美好时刻，首先向全体员工和合作伙伴们致以我最诚挚的问候和感谢！
kaiyun·开云(中国)官方网站-kaiyun.com的2021年因为你们每一位的参与而奇妙和精彩。
新冠疫情的不确定性，使得2021年仍然是充满挑战的一年。但也因为这些挑战和不确定性，让我们变得更加团结、强大，不惧未来。
Hi Everyone,
I hope your holiday season is off to a bright start!
As 2021 draws to a close, I would like to take the opportunity to look back at some of my favorite moments from 2021, and express my sincere appreciation to our employees and our external partners. Without each one of you, we would not have been where we are today and together, we are building our company from the ground up. Thank you!
2021 is another year filled with challenges as we continue to experience the uncertainties of the COVID-19 pandemic. As we continue to navigate uncharted waters, we, as a close knit team with a mission to create are growing stronger as each day goes by.
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在kaiyun·开云(中国)官方网站-kaiyun.com与systimmune全体员工的不懈努力下，我们的SEBA双特异性抗体平台、GNC多特异性抗体平台、SHRI-ADC药物平台都取得了里程碑式的突破。
2021年，我们已经有7个全球领先的创新药陆续从临床前进入到临床试验阶段。包括双抗SI-B001、SI-B003，四抗GNC-038、GNC-039、GNC-035，及双抗ADC药物BL-B01D1，和SI-F019。
The entire team at SystImmune remained focused on innovative science in our drug development and our collaborative work with Baili’s R&D team has both deepened in the subject matters and widened in scope. As many of you know, this year marked a therapeutic milestone for our antibody drug conjugate capabilities. Importantly, we made major progress on the next generation development of GNC, which effectively solidified our leadership in multi-specific therapeutic antibody technology in oncology.
第一个进入临床研究的双特异性抗体 SI-B001（EGFR X Her3）在12月进入了II期，并即将启动SI-B001与泰瑞沙（奥西替尼）联合治疗的临床研究项目。其他正在I 期试验阶段的抗体药物，也都按照既定计划顺利推进。
Progressing from preclinical development into clinical trials is the result of our efficient Ｅxecution of a long-planned strategy. Currently, we have 7 molecules in Phase I or II clinical trials in China, including SI-B001, SI-B003, SI-F019, GNC-038, GNC-039, GNC-035, and BL-B01D1. Our first project, SI-B001, targeting EGFR and Her3 with a bispecific tetravalent, started enrollment for Phase II in December 2021, a pivotal milestone for oncology therapeutic testing. In addition, just a few days ago, we kicked off our collaborative relationship with AstraZeneca in connection with the clinical studying of SI-B001 in combination with TAGRISSO (osimertinib).
双抗ADC药物BL-B01D1在10月获批IND 是我们的另一个里程碑，更加值得欣喜的是，BL-B01D1已经于12月在中山大学肿瘤医院成功入组第一个患者。第二个ADC药物，BL-M02D1(Trop2)即将IND，第三个ADC药物也将同时pre-IND。
The advanced approach of BL-B01D1 is our first bispecific ADC that received IND approval, which is another milestone. Not long after its IND approval in October, we accepted the first patient for the Phase I trial in December 2021. TROP2 specific agent is the second ADC in line and it is currently in pre-IND. All other active Phase I trials have shown no cause for safety related delays and are underway as planned.
SI-B001也已在美国启动了申请IND，并有望于2022年中获得FDA的批准。美国临床开发与临床研究团队的组建工作也在如期进行中。
As you may know, recently we have partnered with a U.S. based CRO to initiate our first US IND for SI-B001 drug. Our goal is to receive FDA approval of the IND around mid-2022. In the meantime, we have started to build up our U.S. clinical development team to bring in U.S. trial management capabilities onsite at SystImmune. With more clinical data to be generated and collected in 2022, we will be well position to advance our current research projects and to get closer to our mission of bringing new drugs and innovation to cancer treatment.
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即使kaiyun·开云(中国)官方网站-kaiyun.com和Systimmune相隔半个地球，却仍因为我们有着共同的使命--为肿瘤治疗带去突破性疗效的创新药，而紧紧相连。我为拥有这样一个智慧、专业、奉献的团队而感到骄傲。期待我们可以很快见面，在下一个里程碑到来之时，共同举杯欢庆。
感谢kaiyun·开云(中国)官方网站-kaiyun.com所有合作伙伴一直以来的支持和关心！
感谢kaiyun·开云(中国)官方网站-kaiyun.com临床研究项目所有参研中心的每位研究者的信任与付出！
感谢kaiyun·开云(中国)官方网站-kaiyun.com全体员工在2021年的坚持和努力！
新年快乐！期待我们会拥有一个更加美妙灿烂的2022年！
I am so proud to have such a great team and I enjoy working with you all even though we are half a world apart. For those that I have not met in person, I am eager to know you more and to meet you in person next year. Your talent, work ethics, and your devotion to science and to our mission inspire me.
At the same time, I would also like to thank our partners, including corporate attorney Qingqing, and our patent lawyer Dr. Connie Wang and Dr. Yangsong Gu, and our HR Taylor for their high quality professional services.
Thank you again for all your effort and dedication in 2021. We look forward to another prosperous year in 2022. I wish you all a warm and healthy holiday season and a happy 2022.
Sincerely,
Yi Zhu
President & CEO
董事长：朱义
