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35 个在研产品,其中 24 个为创新药;
380 余位科学家组成的专业研发团队;
拥有抗体药物国家工程研究中心与生物药和化药双平台的四大综合性研发中心;
生产全球独家上市的重组人血小板生成素——特比澳;
在全球拥有五大生产基地:沈阳、上海、深圳、杭州、意大利;
11 条抗体药物生产线,产能超过 40000 升,还拥有小分子产品、哺乳动物细胞产品、细菌细胞产品的生产线······
这就是沈阳三生制药有限责任公司(以下简称“三生制药”),中国最大的生物技术制药公司,作为“新字号”企业,研究与开发是他们不变的初心,为辽宁企业创新发展树立了标杆。
01研发专注于创新和国际化三生制药创建于 1993 年,从成立那一天起,就敢于创新、追求卓越。经过 20 多年的迅速发展,三生制药集团现已成为一家集研发、生产与销售为一体的中国生物制药领军企业,并在国际市场上大放异彩,是经国家认定的高新技术企业、国家高技术研究发展(863)计划成果产业化基地。自成立以来,已成功研制并上市 4 个重组蛋白药物。
三生制药集团研发专注于创新和国际化。他们依托 380 余位科学家组成的专业研发团队,拥有抗体药物国家工程研究中心与生物药和化药双平台的四大综合性研发中心,其中由国家发展改革委批准的抗体药物国家工程研究中心是全国唯一,该中心学术委员会成员皆由权威院士、知名专家组成。他们在沈阳、上海、深圳和杭州设立四大研发基地,成功建立起生物药和化药双领域研究平台,涵盖从基础研发、临床前研究、临床试验到新药注册上市的药物开发全过程。
他们努力寻求与全球创新伙伴的专业合作,致力于开发新产品,成为少数与国际合作伙伴签订许可和许可协议的中国公司之一。目前,他们拥有丰富的在研产品系列,候选产品35 种,其中 22 种作为国家新药(包括注册分类 1 类和生物药 2 类)。
沈阳三生制药总经理助理袁杰告诉本刊记者:公司在研发创新上能取得一些成绩,主要得益于这些年来他们紧跟世界前沿技术,不断学习并使用;并在全球范围寻找项目,使用公司创立的产业基金进行投资,进行技术引进;同时公司注重上下游产业链的配套,大力发展生物制药生产公共平台,推进孵化器平台建设。
预充式产品包装线
02以高品质生物药惠及患者三生制药集团积极布局包括单克隆抗体产品、双特异性抗体、抗体融合蛋白及细胞疗法等创新疗法研发,产品覆盖肿瘤、自身免疫、肾科、代谢科与皮肤科等治疗领域,从而为患者带来多种治疗方案。他们在全球拥有五大生产基地,分别位于沈阳、上海、深圳、杭州、意大利。他们拥有先进的生产设备:11 条抗体药物生产线,产能超过 40000 升;还拥有小分子产品、哺乳动物细胞产品、细菌细胞产品的生产线。
公司主导产品包括人促红素注射液(益比奥)、重组人血小板生成素注射液(特比澳)。益比奥是唯一获中国国家食品药品监督管理总局批准用于治疗慢性肾病 (CKD) 引起的贫血、化疗引起的贫血 (CIA) 及外科围手术期的红细胞动员三个适应症的重组人促红素产品,获得巴西、土耳其、乌克兰等多个国家的 GMP 认证,以及 20 多个国家的上市批准。自 2002年以来,在中国重组人促红素(rhEPO)市场始终名列第一;特比澳是全球独家上市的重组人血小板生成素,填补了对骨髓三大血细胞系中缺乏调节巨核细胞特异性药物的空白,获得 5项国家发明专利和国家重点新产品、制造业单项冠军产品等多项国家级奖项,2020 年在中国市场血小板减少症治疗用药领域以 72.7% 的份额占据主导地位。
2018 年 2 月,三生制药与中德(沈阳)高端装备制造产业园管委会、中德 ( 沈阳 ) 国际产业投资发展有限公司共同签署合作协议,三方在沈阳中德园内打造一个中国北方生物医药谷,结合各方以及东北地区在资源、技术、人才、资金等各方面的优势,发展以现代生物药产业化为龙头,集生物制药、精准治疗、生物制药原辅材料和高端生物工程装备为一体的产业集群。重点建设五大基地,即建设生物医药研发基地、生物药国际CMO 基地、生物制药原辅材料制造基地、生物制药核心工艺装备基地、生物医药产业人才培养基地。
三生制药近年来经济运行情况良好,工业总产值及营业收入每年以近20% 的增长率稳步递增,并连续多年跻身沈阳市纳税百强企业行列。
03政策支持提升创新能力袁杰介绍,企业创新能力的提升离不开 *** 的支持政策。“十三五”期间,各级 *** 出台多项支持政策,三生制药在科技创新、创新平台建设、数字化转型及创新人才培养等方面已享受多项政策支持。
2021 年, *** 辽宁省委、辽宁省人民 *** 发布“三篇大文章”专项行动计划 (2021-2023 年 ) 以来,多项政策陆续落地,如数字辽宁智造强省专项资金等。三生制药在产业发展、科技创新等方面已享受到来自各级 *** 的多项政策支持,并积极申报 2021年省重点产业发展等相关资金支持项目,其中“聚乙二醇化重组假丝酵母尿酸氧化酶(sss11)车间建设”获得辽宁省工信厅“数字辽宁智造强省”重点产业发展项目 - 生物医药和医疗器械专项资金 1000 万元支持。 *** 的支持更加激发企业参与科技创新的积极性,同时使企业更快地优化整合科技资源,提升科技竞争力及产业化发展水平。
(沈阳三生制药有限责任公司供图)
SSRX is the biggest biotech pharmaceutical company in China. As a NEW enterprise, the company has never changed its pursuit of new innovations in research and development and thats the reason why it is Liaonings model enterprise in innovation and development.
So far the company has 35 products under research, 24 of which are new medicines, a research and development team of 380 scientists, a national research center of antibody medicine, and a research and development center of two platforms in biological and chemical medicines production. SSRX is the only producer of thrombopoietin in the world: the TPO. The company has many production bases in theworld, such as in Shenyang, Shanghai, Shenzhen, Hangzhou, and Italy.
Since its establishment in 1993, Shenyang SSRX has never wavered on its road to innovation and excellence. After more than 20 years development, the company has become a leading enterprise in bio-medicine in China. Its capacity includes research, production and marketing. It has successfully produced and brought to the market four kinds of recombinant protein medicines.
SSRX is looking for global partners in professional cooperation for producing new medicines. It is one the few Chinese companies which have signed franchise and franchise agreement with international partners.
At present, the company has a large series of research products, 35 kinds of candidate products, 22 of which are new medicines in China (including registered classification I and bio medicine II).
Yuan Jie, assistant to the general manager of Shenyang SSRX, told the LT reporter that in the recent years the company has made considerable progress in research and innovation because it has been following the cutting-edge technology in the world and has constantly applied it in use. In the meantime, the company actively looks for international projects and invests in its production bases and technology import. The company has never allowed the disconnection to occur between the upstream and downstream industrial chain. For this reason, shared public platforms for medicine production and platforms for incubators have been established.
In February 2018, SSRX signed a cooperation agreement with the Sino-Germany (Shenyang) administrative committee of the High-tech Equipment Manufacturing Park and Sino-Germany (Shenyang) International Industry & Investment Development Company,Ltd. The three parties will work together to build a North China Bio Medicine Valley in the Sino-Germany Park in Shenyang. Theyll use their advantages in resources, technology, people, and funds available in northeast China and elsewhere to bring forth a combined industrial group, in which modern bio-medicine industry will play a leading role, while other sectors are included, such as targeted treatment, raw material for bio-medicine, and high-level bio project equipment. The following bases are essential to the group: bio-medicine research and development,bio-medicine international CMO, bio-medicine raw material production,equipment for key technologies in bio-medicine production, and personnel training in bio-medical industry.
Since the beginning of the campaign launched in 2021 by Liaoning provincial government to accomplish the Three Agendas (2021-2023), many policies have been implemented, such as the special fund for digitalized Liaoning.SSRX has benefited from these policies and subsidized by governments at different levels. Now the company is applying for the key industry projects which will be financially supported by the provincial government.
(Trans. by G.Q.)
编辑:徐博彦
检校:水 天
责编:景雪峰