沖上云霄前的轟鳴
The roar before the launch
大家新年好！
在即將迎來2022年的美好時刻，首先向全體員工和合作伙伴們致以我最誠摯的問候和感謝！
百利的2021年因為你們每一位的參與而奇妙和精彩。
新冠疫情的不確定性，使得2021年仍然是充滿挑戰(zhàn)的一年。但也因為這些挑戰(zhàn)和不確定性，讓我們變得更加團(tuán)結(jié)、強大，不懼未來。
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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在百利與systimmune全體員工的不懈努力下，我們的SEBA雙特異性抗體平臺、GNC多特異性抗體平臺、SHRI-ADC藥物平臺都取得了里程碑式的突破。
2021年，我們已經(jīng)有7個全球領(lǐng)先的創(chuàng)新藥陸續(xù)從臨床前進(jìn)入到臨床試驗階段。包括雙抗SI-B001、SI-B003，四抗GNC-038、GNC-039、GNC-035，及雙抗ADC藥物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.
第一個進(jìn)入臨床研究的雙特異性抗體 SI-B001（EGFR X Her3）在12月進(jìn)入了II期，并即將啟動SI-B001與泰瑞沙（奧西替尼）聯(lián)合治療的臨床研究項目。其他正在I 期試驗階段的抗體藥物，也都按照既定計劃順利推進(jìn)。
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).
雙抗ADC藥物BL-B01D1在10月獲批IND 是我們的另一個里程碑，更加值得欣喜的是，BL-B01D1已經(jīng)于12月在中山大學(xué)腫瘤醫(yī)院成功入組第一個患者。第二個ADC藥物，BL-M02D1(Trop2)即將IND，第三個ADC藥物也將同時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也已在美國啟動了申請IND，并有望于2022年中獲得FDA的批準(zhǔn)。美國臨床開發(fā)與臨床研究團(tuán)隊的組建工作也在如期進(jìn)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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即使百利和Systimmune相隔半個地球，卻仍因為我們有著共同的使命--為腫瘤治療帶去突破性療效的創(chuàng)新藥，而緊緊相連。我為擁有這樣一個智慧、專業(yè)、奉獻(xiàn)的團(tuán)隊而感到驕傲。期待我們可以很快見面，在下一個里程碑到來之時，共同舉杯歡慶。
感謝百利所有合作伙伴一直以來的支持和關(guān)心！
感謝百利臨床研究項目所有參研中心的每位研究者的信任與付出！
感謝百利全體員工在2021年的堅持和努力！
新年快樂！期待我們會擁有一個更加美妙燦爛的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
董事長：朱義
2021年12月31日
