忠

誠(chéng)

責(zé)任

嚴(yán)謹(jǐn)

創(chuàng)新

關(guān)愛(ài)

服務(wù)

團(tuán)隊(duì)

溝通

公司概況

COMPANY
PROFILE

創(chuàng)建于2005年7月，

總部坐落于美麗的深圳灣畔，后海之濱；

集團(tuán)擁有員工800多名， 其中40%以上為技術(shù)研發(fā)人員；

是我國(guó)最早專(zhuān)業(yè)從事戰(zhàn)略性新興產(chǎn)業(yè)生物治療技術(shù)臨床轉(zhuǎn)化及技

術(shù)服務(wù)的國(guó)家級(jí)高新技術(shù)企業(yè)。

深圳市北科生物科技有限公司

（以下簡(jiǎn)稱(chēng)：北科生物）

Shenzhen Beike Biotechnology Co., Ltd

(hereinafter referred to as Beike)

Founded in July 2005,

Headquartered in Houhai at the beautiful Shenzhen bay;

More than 800 employees, of which more than 40% are research and

development personnel;

China's earliest national high-tech enterprise specializing in the strategic

emerging industries of clinical translation and technical service of

biological treatment technologies.

北科總部及國(guó)際干細(xì)胞研發(fā)基地

01

嚴(yán) 謹(jǐn) · 創(chuàng) 新 · 關(guān) 愛(ài) · 服 務(wù)

02

申請(qǐng)132項(xiàng)細(xì)胞技術(shù)領(lǐng)域相關(guān)專(zhuān)利，106項(xiàng)獲得授權(quán)；

在國(guó)內(nèi)外包括Cell Stem Cell等權(quán)威雜志發(fā)表論文100余篇；

承擔(dān)各級(jí)政府項(xiàng)目60余項(xiàng)，其中6項(xiàng)國(guó)家級(jí)項(xiàng)目（2項(xiàng)863項(xiàng)目）。

Application of 132 cell field-related patents, with 106already approved;

Published more than 100 articles at authoritative domestic and

international journals, including Cell Stem Cell;

Commitment to more than 60 government projects at all levels, of which 6

are state-level projects (including two 863 projects).

03 創(chuàng)始?

THE
FOUNDER

Dr. Sean Hu

Founder and Chairman of

Beike Biotechnology

北科生物創(chuàng)始人、董事長(zhǎng)

胡雋源博士

●國(guó)家干細(xì)胞與再生醫(yī)學(xué)產(chǎn)業(yè)技術(shù)創(chuàng)新戰(zhàn)略聯(lián)盟副理事長(zhǎng)

●深圳市國(guó)家級(jí)領(lǐng)軍人才

●雄安國(guó)際健康論壇執(zhí)行主席

●博鰲亞洲論壇世界生命科學(xué)論壇發(fā)起人

●聯(lián)合國(guó)兒童基金會(huì)國(guó)際顧問(wèn)委員會(huì)委員

●深圳市干細(xì)胞工程技術(shù)研究開(kāi)發(fā)中心主任

●改革開(kāi)放40年影響中國(guó)的深商領(lǐng)袖之一

● Vice Chairman, the China National Technology Innovation Strategic

Alliance of Stem Cell and Regenerative Medicine Industry

● A National Leading Talent in Shenzhen

● Executive Chairman, Xiongan International Health Forum

● Promoter of the World Life Science Forum at Boao Forum for Asia

● A member of the International Council of the United Nations Children's Fund

● Director-General, Shenzhen Stem Cell Engineering Technology Research and

Development Center

● One of the Shenzhen business leaders who influenced China in the 40 years of

reform and opening up

戰(zhàn)略平臺(tái)

STRATEGIC
PLATFORM

綜合細(xì)胞庫(kù)暨區(qū)域細(xì)胞制備中心網(wǎng)絡(luò)

“鋪設(shè)”一條既能滿(mǎn)足臨床需求及時(shí)性又兼顧生產(chǎn)規(guī)?；?lián)通臨床需求方

和先進(jìn)技術(shù)供給方的“細(xì)胞治療高速公路網(wǎng)”，已形成覆蓋華南、華東、華

中、華北、西南、西北的個(gè)體化細(xì)胞治療產(chǎn)業(yè)公共技術(shù)服務(wù)平臺(tái)。為細(xì)胞治

療技術(shù)臨床轉(zhuǎn)化提供創(chuàng)新性的公共技術(shù)平臺(tái)和基礎(chǔ)設(shè)施，為我國(guó)細(xì)胞治療產(chǎn)

業(yè)發(fā)展模式提供一條可借鑒的創(chuàng)新之路。

Network for Cell Banks and Regional Cell Manufacturing Centers

By laying out a “cell therapy expressway network” that can meet clinical needs

including quantity, quality and timeliness, it provides an innovative public

technology platform and infrastructure for clinical translation of cell therapy

technologies.It already covers all major regions of China and is achieving

outstanding results, providing a new way for China's cell therapy industry to

develop.

嚴(yán) 謹(jǐn) · 創(chuàng) 新 · 關(guān) 愛(ài) · 服 務(wù)

04

05 服務(wù)于各區(qū)域戰(zhàn)略需求的科研和產(chǎn)業(yè)基礎(chǔ)設(shè)施，解決各區(qū)域由于缺乏綜合細(xì)胞庫(kù)，從而限制不同來(lái)

源細(xì)胞治療技術(shù)的研究、開(kāi)發(fā)和產(chǎn)業(yè)化發(fā)展的問(wèn)題。在北科生物嚴(yán)格的建庫(kù)標(biāo)準(zhǔn)下，將多種組織來(lái)

源（臍帶、胎盤(pán)、脂肪、乳牙、子宮蛻膜等）成體干細(xì)胞、IPS細(xì)胞、免疫細(xì)胞等寶貴細(xì)胞資源進(jìn)

行儲(chǔ)存，為難治性疾病的治療、急性損傷修復(fù)和藥物篩選等多個(gè)方面提供強(qiáng)力支持！

As research and industrial infrastructures serving the strategic needs of every region, it addresses the problems

that impact research, development and industrialization of Cell therapy technologies caused by the lack of

integrated cell banks. Under Beike's strict cell bank standards, stem cells from different tissues (such as

umbilical cord, bone marrow, placenta, fat, deciduous teeth, decidua and more), iPS cells, immune cells and

other precious cells are stored, providing strong support for various procedures, including treatment of

refractory diseases, recovery from acute injuries and drug screening.

Integrated cell Bank

綜合細(xì)胞庫(kù)

嚴(yán) 謹(jǐn) · 創(chuàng) 新 · 關(guān) 愛(ài) · 服 務(wù)

06

北科生物的大型區(qū)域細(xì)胞制備中心設(shè)于廣東深圳、江蘇泰州、河北石家莊、江西南

昌、貴州貴陽(yáng)，包括細(xì)胞制備區(qū)、檢測(cè)區(qū)、行政輔助區(qū)等獨(dú)立功能區(qū)，配套流式細(xì)胞

儀等國(guó)際先進(jìn)的儀器設(shè)備。中心著重雙特異抗體免疫細(xì)胞、多抗原誘導(dǎo)免疫細(xì)胞、細(xì)

胞儲(chǔ)存等技術(shù)的自主開(kāi)發(fā)，構(gòu)筑細(xì)胞治療基礎(chǔ)研究、臨床科研及臨床應(yīng)用基地，實(shí)現(xiàn)

個(gè)體化細(xì)胞治療技術(shù)的產(chǎn)業(yè)化。

區(qū)域細(xì)胞制備中心

Beike Biotechnology has situated large regional manufacturing facilities for personalized Cell

therapy in Shenzhen (Guangdong), Taizhou (Jiangsu), Shijiazhuang (Hebei), Nanchang (Jiangxi) and

Guiyang(Guizhou)which have independent functional areas including cell preparation, testing and

administration, and are equipped with advanced apparatuses. These centers develop technologies of

bi-specific antibody immune cells, multi-antigen-induced immune cells and stem cell storage,

establishing a fundamental base for cell therapies,clinical research and application,and

industrialization of personalized cell therapy technologies.

Regional cell Manufacturing Center

各區(qū)域建立生物治療所需的各類(lèi)細(xì)胞制品的制造、檢驗(yàn)、鑒定等為一體的綜合性細(xì)胞生物技術(shù)轉(zhuǎn)化應(yīng)用平臺(tái)。定位：

建立嚴(yán)格的質(zhì)量控制和評(píng)價(jià)體系，確保細(xì)胞制備的均一性、穩(wěn)定性、可控性、有效性和可追溯性，促進(jìn)最新的生物治療技術(shù)和相關(guān)細(xì)胞產(chǎn)品規(guī)范化、規(guī)?；a(chǎn)業(yè)化。特色：

Establishment of a comprehensive cell therapy technology translation and application platform in all regions to prepare, test, and evaluate different types of cell products for biotherapy. Positioning:

A strict quality control and assessment system to set up ensure uniformity, stability, controllability, effectiveness and traceability of cell preparations; and promote the standardization, mass production and industrialization of the latest biotherapy technologies. Characteristics:

從人員資質(zhì)、儀器設(shè)備配置、耗材、工藝流程、發(fā)放標(biāo)準(zhǔn)等全部采用統(tǒng)一標(biāo)準(zhǔn)，以保證供給該區(qū)域所有科研機(jī)構(gòu)和臨床應(yīng)用機(jī)構(gòu)的細(xì)胞有效性和安全性，擁有獨(dú)立質(zhì)量控制管理中心。

(1)Unified standards: Independent quality control centers following unified standards for employee qualification, apparatus c o n f i g u r a t i o n , c o n s u m a b l e s, t e c h n o l o g i c a l p r o c e ss e s a n d distribution ensure effectiveness and safety of cells provided to regional research institutes and clinical applications.優(yōu)勢(shì)： Advantages:①標(biāo)準(zhǔn)統(tǒng)一：

每個(gè)區(qū)域只建設(shè)一個(gè)區(qū)域細(xì)胞制備中心，安全監(jiān)管工作量大為減少，監(jiān)管成本將大大降低。 (2) Centralized management and lower regulatory costs Only one regional cell manufacturing center per region lowers workload and cost for safety supervision.②集中管理，

監(jiān)管成本降低：

細(xì)胞保存、細(xì)胞制備與細(xì)胞治療具有不同的技術(shù)規(guī)范與標(biāo)準(zhǔn)，術(shù)業(yè)各有專(zhuān)攻，由專(zhuān)業(yè)的機(jī)構(gòu)建設(shè)區(qū)域細(xì)胞制備中心，醫(yī)療機(jī)構(gòu)專(zhuān)注于疾病的細(xì)胞治療符合科學(xué)發(fā)展規(guī)律。 (3) Efficient labor division and cooperation Professional institute estanlishs a regional cell manufacturing center and handle the different specifications and standards of cell banking, preparation and therapy, allowing medical institutes to concentrate on treating disease with cell therapies in compliance with scientific regulations.③專(zhuān)業(yè)分工，

協(xié)同互補(bǔ)：

產(chǎn)品與服務(wù)

PRODUCTS
AND
SERVICES

細(xì)胞儲(chǔ)存服務(wù)

“綜合細(xì)胞庫(kù)+區(qū)域細(xì)胞制備中心”網(wǎng)絡(luò)是目前世界上少有的超大規(guī)模自體細(xì)

胞儲(chǔ)存與制備服務(wù)平臺(tái)，專(zhuān)注、專(zhuān)業(yè)、專(zhuān)一致力于為每個(gè)家庭提供包括臍帶、

脂肪、乳牙、胎盤(pán)、羊膜等來(lái)源的干細(xì)胞以及人外周血來(lái)源的免疫細(xì)胞等不同

組織來(lái)源的特定的人類(lèi)細(xì)胞系儲(chǔ)存服務(wù)。

臍 帶

Umbilical cord

胎 盤(pán)

Placenta

外周血

Peripheral blood

乳 牙

Deciduous teeth

脂 肪

Adipose

Beike's “Integrated cell bank + regional cell manufacturing center” network is one of the

few large scale somatic cell storage and preparation service platforms in the world. It is

dedicated, professional, and fully committed to provide every family with cell storage

services of specific human cells from different tissues, including stem cells from the

umbilical cord, fat, deciduous teeth, placenta, amniotic membrane and other sources, and

immune cells from peripheral blood. Beike Biotechnology is your trustworthy cell bank.

Cell banking services

09

北科生物“以質(zhì)量為先”，一直全方位高標(biāo)準(zhǔn)嚴(yán)格按照AABB相關(guān)標(biāo)準(zhǔn)開(kāi)展干細(xì)胞、免疫細(xì)胞

等多種細(xì)胞的采集、運(yùn)輸、制備、質(zhì)量檢驗(yàn)管理、儲(chǔ)存、發(fā)放、設(shè)備維護(hù)、人員培訓(xùn)等業(yè)務(wù)工

作，同時(shí)不斷完善和規(guī)范細(xì)胞庫(kù)的各項(xiàng)規(guī)章制度和管理措施，定期落實(shí)內(nèi)部監(jiān)查稽核工作，讓

儲(chǔ)存在北科生物細(xì)胞庫(kù)的細(xì)胞能得到行業(yè)內(nèi)全球最高標(biāo)準(zhǔn)的質(zhì)量保障。

北科生物一直致力質(zhì)量管理體系的建設(shè)。北科生物“出品”的每一份細(xì)胞涉及680+份標(biāo)準(zhǔn)文

件，870+份質(zhì)量記錄，最高達(dá)910+項(xiàng)質(zhì)量控制節(jié)點(diǎn)的檢測(cè)或確認(rèn)，保障每一份細(xì)胞具有可回

溯性、可追蹤性，用實(shí)力讓儲(chǔ)戶(hù)安心。

Beike prioritizes quality, and always maintains high standards in strict accordance with the AABB on stem

cell, immune cell and other cell collection, transportation, preparation, quality inspection, storage,

distribution, equipment maintenance, personnel training. Beike constantly improving and standardizs

guidelines, regulations and management measures, and regularly carries out internal oversight, ensuring

that cells stored at Beike cell bank are at the world's highest standards of quality assurance within the

industry.

嚴(yán) 謹(jǐn) · 創(chuàng) 新 · 關(guān) 愛(ài) · 服 務(wù)

Beike Biotechnology has been committed to building its quality management system. Each cell “produced”

by the company involves 680+ standard documents, 870+ quality records, and up to 910+ points of

inspection or confirmation for quality control. Such a quality control system ensures the traceability of cell

growth and guarantees the safety of the cells for our storage users.

10

細(xì)胞制備服務(wù)

北科生物引領(lǐng)制定細(xì)胞制備行業(yè)標(biāo)準(zhǔn)，建立嚴(yán)格完善的質(zhì)控體系，掌

握先進(jìn)的細(xì)胞技術(shù)，攜手國(guó)際一流的科研機(jī)構(gòu)，服務(wù)于北科客戶(hù)！我

們?yōu)閺V大市民、科研單位、醫(yī)療機(jī)構(gòu)等提供各類(lèi)標(biāo)準(zhǔn)統(tǒng)一的細(xì)胞制品

的制造、檢驗(yàn)、鑒定等為一體的綜合性細(xì)胞生物技術(shù)服務(wù)。

Beike leads the establishment of industry standards for cell preparation,

setting up strict quality control systems, applying advanced cell technologies,

working together with first-class international scientific research

institutions, and serving Beike customers.We provide a wide range of

integrated cell biotechnology services including cell preparation, inspection,

identification and other services all at standardized levels to citizens,

scientific research units, medical institutions and more.

Cell manufacting services

11

嚴(yán) 謹(jǐn) · 創(chuàng) 新 · 關(guān) 愛(ài) · 服 務(wù)

細(xì)胞治療技術(shù)研究與臨床轉(zhuǎn)化

Joint national-local personalized cell therapy technology engineering

laboratory;

Innovation and development platform for the biological treatment

technology industry;

Beike Biotechnology has cooperated with more than 100 domestic and

international research and medical institutions in cell therapy, providing

personalized cell therapies for over 100,000 patients with refractory diseases

from more than 70 countries such as the United States, Canada, Britain and

Japan, and receiving recognition in its treatment results and cell quality by

the international academic community.

Cell therapy research and clinical translation

個(gè)體化細(xì)胞治療技術(shù)國(guó)家聯(lián)合地方工程實(shí)驗(yàn)室；

生物治療技術(shù)產(chǎn)業(yè)領(lǐng)域的“雙創(chuàng)平臺(tái)”；

北科生物與國(guó)內(nèi)外近百家科研及醫(yī)療機(jī)構(gòu)開(kāi)展細(xì)胞治療技術(shù)研究合

作，為2萬(wàn)多例、10萬(wàn)多人次難治性疾病患者的細(xì)胞治療提供標(biāo)準(zhǔn)

化、可追溯的個(gè)體化細(xì)胞制備技術(shù)服務(wù)，包括來(lái)自美國(guó)、加拿大、

英國(guó)、日本等70多個(gè)國(guó)家的患者，良好的細(xì)胞制備質(zhì)量及顯著的效

果獲得國(guó)際同行認(rèn)可。

12

13 ISO14001

ISO14001：要求組織通過(guò)建立環(huán)境管

理體系來(lái)達(dá)到支持環(huán)境保護(hù)、預(yù)防污染

和持續(xù)改進(jìn)的目標(biāo)，并通過(guò)取得第三方

認(rèn)證機(jī)構(gòu)認(rèn)證的形式，向外界證明其環(huán)

境管理體系的符合性和環(huán)境管理水平。

通過(guò)ISO14001質(zhì)量管理體系認(rèn)證。

Beike Biotechnology has been certified by

ISO 14001 Quality Management System

ISO 14001 requires organizations to attain

the goal of supporting environmental

protection, pollution prevention and

continuous improvements by building an

environmental management system as well

as to prove the conformity of their

environmental management system and

environmental management level by passing

the certification of the third-party

certification body.

ISO9001

ISO9000族 標(biāo) 準(zhǔn) 是 “ 國(guó) 際 標(biāo) 準(zhǔn) 化 組

織 ” （ ISO） 提 出 的 概 念 ， 是 指 由

ISO/Tc176（“國(guó)際標(biāo)準(zhǔn)化組織質(zhì)量

管理和質(zhì)量保證技術(shù)委員會(huì)”）制定

的國(guó)際標(biāo)準(zhǔn)。

Beike Biotechnology has been certified by

ISO 9001 Quality Management System

The ISO 9000 family of standards is

p r o p o s e d b y t h e I n t e r n a t i o n a l

Organization for Standardization (ISO)

and enacted by the ISO Technical

Committee (ISO/TC176).

通過(guò)ISO9001質(zhì)量管理體系認(rèn)證。

質(zhì)量管理體系

QUALITY
MANAGEMENT
SYSTEM

14

OHSAS18001

OHSAS18001：是20世紀(jì)80年代后期

在國(guó)際上興起的現(xiàn)代安全生產(chǎn)與職業(yè)

健康安全管理模式，它與ISO9001和

ISO14001等標(biāo)準(zhǔn)規(guī)定的管理體系一并

被稱(chēng)為后工業(yè)劃時(shí)代的管理方法。

通過(guò)OHSAS18001質(zhì)量管理體系認(rèn)證。

Beike Biotechnology has been certified by

OHSAS 18001 Quality Management

System.

OHSAS18001 is a modern safe production

management model that emerged in the

world in the late 1980s. It is referred to as a

post-industrial epoch-making management

system along with the management systems

ISO 9001 and ISO 14001.

AABB

中國(guó)大陸第一家通過(guò)全球先進(jìn)的輸血和細(xì)

胞治療技術(shù)聯(lián)盟（AABB）認(rèn)證的單位。

AABB : 全球先進(jìn)的輸血和細(xì)胞治療

技術(shù)聯(lián)盟（原名：美國(guó)血庫(kù)協(xié)會(huì)），

是全世界水平最高的細(xì)胞治療服務(wù)標(biāo)

準(zhǔn)認(rèn)證機(jī)構(gòu)。

Beike Biotechnology is the first

enterprise certified by AABB-the world's

advanced blood transfusion and cell

therapy technology alliance-in Mainland

China

AABB: the world's advanced transfusion

and cell therapy technology alliance

andformerly known as the American

Association of Blood Banks, is the

highest-level cell therapy standard

certification body in the world.

ISCT

中國(guó)第一家獲得國(guó)際細(xì)胞治療協(xié)會(huì)

(ISCT)認(rèn)可的會(huì)員單位。

ISCT：國(guó)際細(xì)胞治療協(xié)會(huì)，是致力于

細(xì)胞研究、制備、處理及臨床移植的

國(guó)際專(zhuān)業(yè)組織。

Beike Biotechnology is the first member

unit approved by the International

Society for Cellular Therapy (ISCT) in

China

ISCT: International Society for Cellular

Therapy is an international professional

organization devoted to cell research,

preparation and processing, as well as

clinical transplantation.

嚴(yán) 謹(jǐn) · 創(chuàng) 新 · 關(guān) 愛(ài) · 服 務(wù)

15 技術(shù)優(yōu)勢(shì) TECHNICAL
ADVANTAGES

Through strategic licensing, acquisition and independent R&D, Beike has

established an important strategic position in the field of immunotherapy.

Beike possesses multiple cutting-edge and innovative immunotherapy

technologies and products. ALT-803 is considered by the NCI to be the most

promising interleukin drug for cancer treatment. MAR-based (MHC Antigen

Receptor) antibodies and bi-specific antibodies, and MAR-T and MAR-NK

cell therapies have shown to be more effective than conventional CAR-T,

TCR-T and bi-specific antibodies in treating hematologic and solid tumors,

viral infections and other diseases.

Advanced immune cell therapy technologies

先進(jìn)的免疫細(xì)胞治療技術(shù)

通過(guò)戰(zhàn)略性授權(quán)，并購(gòu)和自主研發(fā)，北科生物在免疫治療領(lǐng)域占有

重要的戰(zhàn)略地位。北科生物擁有多種國(guó)際先進(jìn)的免疫治療技術(shù)和產(chǎn)

品。ALT-803被NCI認(rèn)為是最有希望治愈癌癥的白介素類(lèi)藥物。在主

要組織相容性復(fù)合物抗原識(shí)別受體研發(fā)平臺(tái)開(kāi)發(fā)MAR-T、MARNK細(xì)胞治療比目前的常規(guī)的CAR-T、TCR-T和雙特異性抗體，在惡

性血液病、實(shí)體瘤和病毒感染等疾病方面具有更顯著的治療優(yōu)勢(shì)。

16

嚴(yán) 謹(jǐn) · 創(chuàng) 新 · 關(guān) 愛(ài) · 服 務(wù)

在過(guò)去的幾年，T細(xì)胞嵌合抗原受體技術(shù)已經(jīng)在腫瘤治療領(lǐng)域取得了革命性的突破，而且已經(jīng)改變了傳統(tǒng)的腫瘤

治療方法。嵌合抗原受體技術(shù)利用基因工程技術(shù)改造T細(xì)胞，使T細(xì)胞表面表達(dá)識(shí)別腫瘤抗原受體，增強(qiáng)T細(xì)胞識(shí)

別腫瘤抗原的能力，削弱腫瘤的免疫耐受性。嵌合抗原受體技術(shù)已經(jīng)顯示出了巨大的癌癥治療潛力。目前的嵌合

抗原受體只能識(shí)別細(xì)胞表面抗原。然而，80-90%的癌癥抗原是細(xì)胞內(nèi)抗原，嵌合抗原受體無(wú)法識(shí)別。在MAR技

術(shù)平臺(tái)下，北科將開(kāi)發(fā)一系列的細(xì)胞治療產(chǎn)品，包括MAR-T（基于MAR的CAR-T技術(shù)）和MAR-NK。以MAR為

識(shí)別受體的CAR-T和CAR-NK細(xì)胞治療與常規(guī)的CAR-T相比，MAR-T能夠識(shí)別的抗原譜更廣，同時(shí)又比TCR-T技

術(shù)具有更強(qiáng)的特異性和親和力，安全性更高。

In the past few years, T cell chimeric antigen receptor (CAR-T) technology has led to a revolution in the oncology field and

changed the landscape of medical oncology. CAR-T technology uses genetic engineering to have T cells express antigen

receptors, enhancing T cells to target cancer antigens and overcoming immunotolerance. CAR-T has shown great potential in

cancer treatment. CAR-T technology in its current form can only target cancer antigens on the cell surface. However, 80-90%

of cancer targets are intracellular, which CAR-T

cannot access. Based on MAR technology, Beike will launch a series of cell therapy products, including MAR-T (MAR based

CAR-T) and MAR-NK. MAR-based CAR-T cell and CAR-NK cell therapy have advantages as compared to regular CAR-T –

they have a much wider

spectrum of target binding. Compared with TCR-T technology, it also has better specificity and affinity, and should be much

safer.

MAR-based cell therapy

基于MAR的細(xì)胞治療

美國(guó)國(guó)立腫瘤研究所曾經(jīng)認(rèn)為IL-15是最有可能治愈腫瘤的白介素類(lèi)藥物。ALT-803是重組的IL-15超級(jí)激動(dòng)劑

蛋白。它能夠有效的刺激免疫細(xì)胞抵抗惡性血液病，實(shí)體瘤和病毒感染的細(xì)胞。目前Altor公司已經(jīng)在美國(guó)開(kāi)

展多項(xiàng)針對(duì)多種癌癥治療的ALT-803臨床試驗(yàn)。除了ALT-803治療藥物以外，北科生物同時(shí)以ALT-803為基礎(chǔ)

開(kāi)發(fā)803細(xì)胞培養(yǎng)液。803細(xì)胞培養(yǎng)液能夠顯著增強(qiáng)T細(xì)胞和NK細(xì)胞在體內(nèi)和體外的存活率。

As a result of encouraging pre-clinical studies, the NCI considers IL-15 as one of the most promising therapeutic agents in

cancer treatment. ALT-803 is a recombinant human superagonist interleukin-15(IL-15). It is a potent immunotherapeutic

agent capable of activating immune cell responses against hematologic and solid tumors and virally infected cells. ALT-803 is

currently in clinical development and is being evaluated by Altor in multiple U.S.-based clinical trials in various cancer

indications. In addition to the ALT-803 therapeutic drug, Beike is also developing 803 cell culture medium. The 803 cell

culture medium will significantly enhance the persistence of T and NK cells ex vivo and in vivo.

ALT-803

ALT-803

北科專(zhuān)利：

申請(qǐng)132項(xiàng)細(xì)胞技術(shù)領(lǐng)域相關(guān)專(zhuān)利，

106項(xiàng)獲得授權(quán)，部分專(zhuān)利列表如下：

application for 132 cell technology

patents, 106 approved,with part of

the patents listed as follows:

腹側(cè)急性閉合性脊髓損傷動(dòng)

物模型的專(zhuān)用腹側(cè)打擊器

ZL200710077438.x

干細(xì)胞凍存液及干細(xì)胞的凍

存方法

ZL200910167171.2

一種可植入的披膜三維載體

及其制備方法

ZL201010224488.8

一種高效誘導(dǎo)人類(lèi)體細(xì)胞重

編程為多潛能干細(xì)胞方法

ZL201010593844.3

單個(gè)核細(xì)胞培養(yǎng)液 ZL201110221115.X

細(xì)胞轉(zhuǎn)核誘導(dǎo)體細(xì)胞成多能

二倍體干細(xì)胞的方法

ZL201110243239.8

通過(guò)mRNA誘導(dǎo)體細(xì)胞為多

能干細(xì)胞的方法

ZL201110243254.2

一種分離單個(gè)核細(xì)胞的方法

和裝置

ZL200810089682.2

能誘導(dǎo)干細(xì)胞向成骨細(xì)胞分

化的微小RNA及其應(yīng)用

200810225514

一種高效誘導(dǎo)多能性干細(xì)胞

的重組腺病毒載體、使用該

載體的誘導(dǎo)方法及其用途

ZL200910045714.3

一種預(yù)防腫瘤復(fù)發(fā)和抑制腫

瘤生長(zhǎng)的寡聚核酸及其應(yīng)用

ZL201010137856.5

體內(nèi)和體外再生細(xì)胞的方法 ZL200680046641.4

干細(xì)胞在制備治療帕金森病

的制劑中的用途

Zl2013101668044

臍帶間充質(zhì)干細(xì)胞在制備治

療紅斑狼瘡的制劑中的用途

ZL201310138408.0

帕金森氏病動(dòng)物模型平臺(tái)及

其在藥物篩選中的用途

2012105855609

一種具有雙特異性抗體的細(xì)

胞CTL（BiAT）、其制備方

法及其應(yīng)用

201310442787.2

一種可用于肝衰竭治療的經(jīng)

HGF基因修飾的UCMSC制備

方法

201410841610.4

牙齒來(lái)源間充質(zhì)干細(xì)胞體外分

離與培養(yǎng)方法

201410841531.3

一種制備絨毛膜間充質(zhì)干細(xì)胞

的方法

201410795197.2

一種制備蛻膜間充質(zhì)干細(xì)胞的

方法

201410795200.0

間充質(zhì)干細(xì)胞外泌體在制備治

療肺纖維化的藥物制劑中的應(yīng)用

201510091820.0

臍帶間充質(zhì)干細(xì)胞在制備治療

肺纖維化的藥物制劑中的應(yīng)用

201510091984.3

一種用于免疫治療的EB病毒

LMP2A串聯(lián)表位肽及其作用 201510963795.0

一種抗CD16A抗原和抗MUC1

抗原的雙特異性抗體 201510974016.7

分泌TRAIL的間充質(zhì)干細(xì)胞及

其治療腦瘤的用途

201610176358.9

一種人臍帶間充質(zhì)干細(xì)胞的制

備方法

ZL201010528733.4

一種臍帶保存液及其制備方法 Zl2011102193931

一種臍帶血分離二聯(lián)袋分離造

血干細(xì)胞的方法

Zl2011102194084

臍帶間充質(zhì)干細(xì)胞數(shù)字化自動(dòng)

生產(chǎn)系統(tǒng)

ZL2011101767125

經(jīng)血間充質(zhì)干細(xì)胞的培養(yǎng)方法 201410836460.8

臍帶間充質(zhì)干細(xì)胞數(shù)字化自動(dòng)

生產(chǎn)方法

ZL2011101766936

專(zhuān)利名稱(chēng) 專(zhuān)利號(hào) 專(zhuān)利名稱(chēng) 專(zhuān)利號(hào)

201410531197.1

可分泌型TRAIL蛋白構(gòu)建物和

表達(dá)載體

人羊膜間充質(zhì)干細(xì)胞的分離

及培養(yǎng)方法及醫(yī)用組合物

ZL200610033007.9

研發(fā)優(yōu)勢(shì)

RESEARCH
AND

DEVELOPMENT
ADVANTAGE

Beike patents:

17

嚴(yán) 謹(jǐn) · 創(chuàng) 新 · 關(guān) 愛(ài) · 服 務(wù)

北科論文：

發(fā)表學(xué)術(shù)文章百余篇，部分論文列表：

Beike articles：

100+ published academic articles, with some listed as follows:

論 文 名 稱(chēng) 發(fā) 表 雜 志

The effect of central loops in miRNA:MRE duplexes on the efficiency of miRNA-mediated

gene regulation.

Direct-current electrical field guides neuronal stem/progenitor cell migration

Targeted tumor gene therapy based on loss of IGF2 imprinting.

Mesenchymal stem cell transplantation for diffuse alveolar hemorrhage in SLE

Autologous Stromal Vascular Fraction Cells: A Tool for Facilitating Tolerance in

Rheumatic Disease

MiRNA-20a promotes osteogenic differentiationof human mesenchymal stem cellsby

co-regulating BMP signaling

Human umbilical cord mesenchymal stromal cells mitigate chemotherapy-associated

tissue injury in a pre-clinical mouse model

Promotion of the induction of cell pluripotency through metabolic remodelingby

thyroid hormone triiodothyronine-activated PI3K/AKT signal pathway.

C-peptide increase in chronic type 1 diabetic patients treated with autologous bone marrow

cell transplantation through pancreatic artery catheterization: three years follow-up

Early immunotherapy using autologous adult stem cells reversed anti-pancreatic-islets effect

in recently diagnosed type 1 diabetes mellitus: preliminary results.

Intrachromosomal Looping Is Requiredfor Activation of Endogenous Pluripotency

Genesduring Reprogramming.

Transplantation of human cord blood mononuclear cells and umbilical cord-derived

mesenchymal stem cells in autism.

Promoter histone H3K27 methylation in the control of IGF2 imprinting in human tumor

cell lines

Umbilical cord mesenchymal stem cell transplantation in active and refractory

systemic lupus erythematosus: a multicenter clinical study.

Human umbilical cord mesenchymal stromal cells rescue mice fromacetaminophen-induced

acute liver failure.

Human umbilical cord mesenchymal stem cells protect against ischemic brain injury in

mouse by regulating peripheral immunoinflammation.

Hematopoietic recovery of acute radiation syndrome by human superoxide

dismutase-expressing umbilical cord mesenchymal stromalcells.

Intracoronary infusion of Wharton's jelly-derived mesenchymal stem cells in acute

myocardial infarction: double-blind, randomizedcontrolled trial.

Safety of Allogeneic Umbilical Cord Blood Stem Cells Therapy inPatients with Severe

Cerebral Palsy: A Retrospective Study

Characterization and transplantation of enteric neural crest cells from human induced

pluripotent stem cells

Cytotherapy. 2014,16(9):1207-19.

PLOS One, 2008, 3(3):e1719

Stem Cells, 2008, 6(8):2193-200

Cancer Biology &Therapy,

2010, 10(3):290-298.

Nature Reviews Rheumatology,

2010, 6:486–489

Cellular Immunology,2010, 264:7-17

RNA Biology, 2011, 8(5):829-838

Cytotherapy,2012, 14(4):412-422

Biomaterials,2012, 33(22):5514-5523

Stem Cell Discovery, 2013, 3(1):56-63

Medical Science Monitor,2013, 19.

Cell Stem Cell,2013, 13(1):30-35

Journal of Translational Medicine,

2013, 11:196

Human Molecular Genetics,

2014,23(1):117-28.

Arthritis Research & Therapy,

2014 Mar 25;16(2):R79.

Brain Research. 2015,(12)1594:293-304.

Cytotherapy. 2015,17(4):403-17.

BMC Medicine.2015 Jul 10;13:162.

Stem Cells International

Volume 2015,Article ID 325652.

Molecular Psychiatry ,2016,(00): 1-10

18

●北科生物的全球戰(zhàn)略合作伙伴Altor Bioscience Corp參與發(fā)起

“腫瘤登月2020”計(jì)劃的啟動(dòng)

●與Altor Bioscience Corp就新型重組二聚體蛋白復(fù)合物生物制

品——ALT-803達(dá)成跨國(guó)戰(zhàn)略合作（ALT-803：北美腫瘤醫(yī)師

協(xié)會(huì)排名第一的腫瘤免疫創(chuàng)新藥物）

●國(guó)際細(xì)胞治療協(xié)會(huì) (ISCT) 會(huì)員

●受到國(guó)際資本追捧

●Altor Bioscience Corp, a strategic partner of Beike Biotechnology and a

participant in the launch of Cancer Moonshot 2020

●Cross-border strategic cooperation with Altor Bioscience Corp on ALT803 (ALT-803: ranked first among innovative anti-tumor drugs by the

Oncologist Association of North America)

●Member of ISCT

●Capital investments

國(guó)際合作

INTERNATIONAL
COOPERATION

19

●The world's first enterprise releasing the largest collection of research data on the clinical safety of human umbilical cord blood cells

●The world's first case of using umbilical cord stem cells to help a blind patient recover their sight

●The world's first case of using umbilical cord stem cells to help a patient with systemic lupus erythematosus (SLE) regain their health

●The first enterprise approved as a national high-tech enterprise in China's stem cell field

●The first enterprise jointly certified by ISO 9001, ISO 14001 and OHSAS 18001 Quality Management Systems in China's stem cell field

●The first lab certified by ISO17025 (CNAS) in China's stem cell field

●One of the first umbilical cord mesenchymal stem cell banks certified by AABB in the world

●The first umbilical cord blood stem cell bank certified by AABB in Mainland China

●The first stem cell bank that passed site reexamination accreditation by AABB in Mainland China

●The first enterprise in the history of AABB that earned accreditation of four products at the same time

●The first peripheral blood immune cell storage technology quality management system certified by AABB in the world

●The first regional manufacturing facility for personalized cell therapy approved and built in China

資質(zhì)榮譽(yù)

HONORS
AND
QUALIFICATIONS

嚴(yán) 謹(jǐn) · 創(chuàng) 新 · 關(guān) 愛(ài) · 服 務(wù)

●世界上第一家公布最大規(guī)模人臍血單個(gè)核細(xì)胞臨床安全性研究數(shù)據(jù)的企業(yè)

●世界上第一例人臍帶來(lái)源干細(xì)胞令失明的患者重見(jiàn)光明

●世界上第一例人臍帶來(lái)源干細(xì)胞令系統(tǒng)性紅斑狼瘡(SLE)患者重拾健康

●中國(guó)干細(xì)胞領(lǐng)域第一家獲得國(guó)家高新技術(shù)企業(yè)認(rèn)定的企業(yè)

●中國(guó)干細(xì)胞領(lǐng)域第一家同時(shí)擁有ISO9001、ISO14001和OHSAS18001質(zhì)量管理體系證書(shū)的企業(yè)

●中國(guó)干細(xì)胞領(lǐng)域第一家通過(guò)中國(guó)合格評(píng)定國(guó)家認(rèn)可委員會(huì)（CNAS）ISO17025認(rèn)可的實(shí)驗(yàn)室

●世界第一批獲得AABB認(rèn)證的臍帶間充質(zhì)干細(xì)胞庫(kù)

●中國(guó)大陸第一家通過(guò)AABB認(rèn)證的臍血干細(xì)胞庫(kù)

●中國(guó)大陸第一家通過(guò)AABB現(xiàn)場(chǎng)復(fù)審認(rèn)證的干細(xì)胞庫(kù)

●AABB認(rèn)證史上第一家四個(gè)產(chǎn)品同時(shí)通過(guò)審核認(rèn)證的單位

●人外周血免疫細(xì)胞儲(chǔ)存應(yīng)用技術(shù)質(zhì)量管理體系全球第一家通過(guò)AABB認(rèn)證

●中國(guó)第一個(gè)獲得批復(fù)并啟動(dòng)建設(shè)的區(qū)域細(xì)胞制備中心

北科生物在細(xì)胞領(lǐng)域不斷創(chuàng)造著中國(guó)第一和世界第一

Beike Biotechnology has achieved many firsts in the cell industry both in

China and in the world

20

獲得的資質(zhì)

Beike's qualifications 北科生物細(xì)胞產(chǎn)業(yè)發(fā)展獲得國(guó)家科技部、發(fā)改委及多個(gè)省市各級(jí)政府的大力支持，且

北科生物的干細(xì)胞與再生醫(yī)學(xué)產(chǎn)業(yè)項(xiàng)目被列入各地產(chǎn)業(yè)重點(diǎn)突破工程項(xiàng)目。

Beike's stem cell industry development has obtained strong support from the National Ministry of

Science and Technology, Development and Reform Commission (NDRC) and a number of

provinces' and cities' government, Beike's stem cell and regenerative medicine industry projects

have been included in the focus on industry breakthrough projects.

深圳市

北科細(xì)胞工程研究所

Chinese Industry and Innovative Technology Strategic Alliance of Stem Cells and Regenerative Medicine

Vice Chairman Unit

Ministry of Science and Technolgy of the People’s Republic of China

廣東省干細(xì)胞再生醫(yī)學(xué)新生物

廣東省科學(xué)技術(shù)廳

工程技術(shù)研究開(kāi)發(fā)中心

深圳市發(fā)展改革委員會(huì)

北科總部及國(guó)際干細(xì)胞研發(fā)基地

深圳市

干細(xì)胞工程技術(shù)研究開(kāi)發(fā)中心

深圳市

干細(xì)胞與再生醫(yī)學(xué)工程實(shí)驗(yàn)室

免疫細(xì)胞質(zhì)量分析檢測(cè)服務(wù)平臺(tái)

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未來(lái)愿景

VISIONS

一個(gè)家庭、一個(gè)群體、一種生存狀態(tài)的改變……

Changes in the state of families, groups and lives……

嚴(yán) 謹(jǐn) · 創(chuàng) 新 · 關(guān) 愛(ài) · 服 務(wù)

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推動(dòng)生物治療技術(shù)臨床轉(zhuǎn)化的領(lǐng)軍企業(yè)，

為改善人類(lèi)健康不懈努力！

推動(dòng)生物治療技術(shù)臨床轉(zhuǎn)化的領(lǐng)軍企業(yè)，

為改善人類(lèi)健康不懈努力！

The leader in promoting clinical translation of biotherapy technologies,

Making unremitting efforts to improve human health!

The leader in promoting clinical translation of biotherapy technologies,

Making unremitting efforts to improve human health!