Jan. 2013 2013年7月 1 Xianyao Road, Xianju, Zhejiang, China 浙江省仙居县仙药路1号 Introduction 简介 A specialty pharmaceutical company dedicated to researching, manufacturing and marketing drug products in women’s health, dermatology, and pain management The largest and most complete steroids manufacturer in China A state-designated manufacturer of reproductive health drugs in China 仙琚制药 ---专业的甾体药物研发和制造, 是国内规模最大、品种最为齐全的甾体药物生产厂家 ---妇科、麻醉科产品专科生产和销售厂家 ---生殖健康药物国家定点生产企业 1 Xianyao Road, Xianju, Zhejiang, China 浙江省仙居县仙药路1号 Facts and History 现状与历史 Total assets – $300 million 总资产为18.16亿人民币 Foundation of the Company Jan 1972 公司成立 1972年1月 Reformed to Xianju Pharma Dec 2001 改制成立浙江仙琚 制药股份有限公司 2001年12月 IPO on Shenzhen Stock Exchange Jan 2010 仙琚制药国内 A股上市 2010年01月 Sales Revenue 销售业绩 $ (Million) 单位: 美元 (百万) ($) 350 315 300 269 227 250 200 150 193 171 146 100 50 0 2007 2008 2009 2010 2011 Sales revenue in the past several years 近几年销售收入比较表 2012 Wide Distribution Channels 专业销售渠道 生殖健康产品 Reproductive health care products 制剂 FPP 销售系统 Distribution System APIs 麻醉科产品 Anesthesiology products 2800家医院 2800 Hospitals 3500家医院 3500 Hospitals 60000家药店 OTC产品 OTC Products 60000 Pharmacies 国内贸易 Domestic Trading 覆盖全国 National coverage 国际贸易 覆盖全球 Global coverage International Trading Distribution Organization 销售机构 300多城市 More than 300 Cities 1300个代理商 1300 Agents 制剂销售系统 Distribution System for Finished Products 700多销售员 More than 700 Sales People 25个办事处 25 Offices Market Shares for Main Products 主要产品市场占有率 • Obstetrics & Gynecology products: – Progesterone Capsules, 29.9% (1st) • Anesthesiology products: – Rocuronium Bromide Injection, 50% (1st) – Vecuronium Bromide Injection, 50% (1st) • OTC product: – Levonorgestrel Enteric-coated Capsules, 21.5% (2nd ) • Others: – Dexamethasone Tablets, 35% – Prednisone Acetate Tablets, 42% – Triamcinolone Acetonide Acetate Injection, 65% • 妇产科产品:益玛欣 29.9% (第一) • 麻醉科产品:罗库溴铵注射液50% (第一)、维库溴铵50% (第一) • OTC产品:左炔肠溶胶囊21.5%(第二) • 其他产品:地塞米松片 35%、强的松片 42%、 醋酸曲安奈德注射液 65% Market Share for Dermatology drug 皮肤科产品市场占有率 • Main dermatology drug: Mometasone Furoate Cream, 20.7% (2nd) • Other dermatology products include Triamcinolone Acetonide and Econazole Cream, and Fluticasone Propionate Cream • Distribution Channel: OTC channel and hospital terminal channel • 皮肤科主要产品:糠酸莫米松乳膏,20.7%(第二) • 其他皮肤科产品包括曲安奈德益康唑乳膏和丙酸氟替卡松 乳膏 • 销售途径:OTC渠道和医院途径 Production Capacity & GMP 生产情况 Production Capacity 产能情况 Tablets: 10 billion/y 片剂 : 100亿片/年 Small volume injection: 200 million/y 小容量针剂: 2亿支/年 Capsules: 500 million/y 胶囊剂 : 5亿颗/年 Lyophilized powder injection: 10 million/y 冻干粉针剂: 1千万支/年 Cream: 10 million/y 乳膏剂: 1千万支/年 Granules: 10 million packets/y 颗粒剂: 1千万包/年 Inhalation: 10 million/y 吸入剂: 1千万瓶/年 API: 200 ton/y 原料药: 200吨/年 GMP Certification GMP认证 Major APIs were GMP-certified by US-FDA and EDQM All production lines of finished products were GMP-certified by China SFDA 主要APIs通过FDA、EDQM官方GMP认证 全部制剂生产线通过中国GMP认证 Research and Development 研发系统 Xianju Institute of Pharmaceutical R&D 仙琚药物研究院 External Collaboration with Academia Advisory Board 顾问团 外部合作研究机构 Zhejiang Xianju Pharmaceutical Technology Co., Ltd 浙江仙琚制药技术开 发有限公司 Clinical Study Bases 各临床研究基地 Dept. of Product Development Dept. of Application Tech. 产品开发部 应用技术部 Center for Intellectual Properties 专利中心 APIs Research 原料药室 Quality Research Product Research 质量研究室 实验部 Joint Laboratory of Resource Chem. and Steroid Chem. 资源化学与甾体化 学联合实验室 Biologics Biology and and Fermentation Research 生物发酵研究室 130 People Formulation Research 制剂室 Pipelines 项目 Three innovative drugs, approximately 50 generic drugs, and 31 patents 在研项目:创新药三个,研仿制药近50个. 专利 31项 创新药研究进展 Pipelines for New Drug Development 治疗领域 Therapeutic Area 妇科 产品 临床前 临床I期 临床II期 临床III期 新药申请 Products Preclinical Phase I Phase II Phase III NDA ZXH951 Gynecology 镇痛 Analgesia 老年痴呆 Alzheimer's Disease 噻吩诺菲 Thienorphine 疫苗 Vaccine Introduction of the New Plant -Yangfu Plant 新厂区-杨府制剂厂区介绍 • Total Area: 106,700m2 – Phase I: 48,700m2 – Phase II: 58,000m2 (Under Construction) 总面积:106700 ㎡ – I期:48700 ㎡ – II期:58000 ㎡(建设中) • Yangfu Plant was designed based on Chinese cGMP ( 2010) with hardware complying to EU-GMP requirements. 按中国新版GMP要求设计,硬件标准达到欧美GMP要求 Five Year Plan –Corporate Strategy 五年规划 –公司战略 Corporate Strategy • Market-driven, specialty-focused • Enhance the leadership role in existing market. •Expand the company rapidly by launching inhouse and in-licensed products. 公司战略 “以营销为导向”、“先做强后做大” Five Year Plan –Corporate Objectives 五年规划 –公司目标 Corporate Objectives •To become one of the Top 50 pharmaceutical companies in China •To be China’s leading pharmaceutical company specialized in Gynecology and Anesthesiology Areas •To establish a worldwide reputation in steroid drug manufacturing and raise brand awareness 公司目标 •整体实力进入全国制药企业50强 •妇科、麻醉科治疗领域成为中国的领先企业 •甾体药物领域成为国际知名企业 International Collaboration of Xianju Pharma Exports of Xianju’s Products – Sales of FPP (Finished Pharmaceutical Product) in non-regulated markets including areas and countries in Latin America, Africa, Southeast Asia. – Sales of API (Active Pharmaceutical Ingredient) in regulated markets including EU, USA, Japan, and other areas and countries – Collaboration model: Agent or our own employee 仙琚产品的出口销售 – 制剂产品的非规范市场销售: 包括拉美、非洲、东南亚等地区和国 家 – 原料药的规范市场销售: 欧盟、美国、日本等地区和国家 – 合作方式:以仙琚代理或雇员方式合作 Seeking source of APIs – Such as Dantrolene, Desogestrel, Bromocriptine, and Dydrogesterone. – Collaboration model: Direct Importation or collaboration on manufacturing 仙琚制剂开发所需的原料药 – 产品举例:丹曲林、去氧孕烯、溴隐亭、地屈孕酮等 – 合作方式:进口或合作生产 Seeking Late Stage or Approved Products – Small molecule and biological drugs: Women health, Dermatology , Pain Management, treatment drugs for addiction and Alzheimer's vaccine – Medical devices: Devices and consumables for Gynecology, Anesthesiology, and Cardiothoracic surgery. – Conduct registration and/or distribute products 产品的进口注册、销售代理 – 药品:妇科、麻醉科、皮肤科、镇痛药、戒毒药和老年痴呆疫苗的 进口注册及销售代理 – 生物制剂:妇科、麻醉科、皮肤科及镇痛生物制剂的进口注册及销 售代理 – 器械:妇科、麻醉科、心胸科医疗器械、耗材的进口注册及销售代 理 Collaborations on New Formulations and New Technologies – In-license and/or co-development of sustained- or controlled-release formulations – In-license and/or co-development of new products and new technologies for steroid hormone APIs 药物新剂型、新技术合作 •缓控释制剂技术、长效制剂的引进、合作开发 •甾体激素原料药的新产品、新技术 Seek Partners to Create Joint Ventures in China – To build joint ventures for research and/or manufacturing – Target collaborators: Foreign pharmaceutical, biotech companies, as well as academia that have new technologies or products – Areas of Interest: Innovative drugs for women’s health, dermatology and pain management, new formulations and techniques for steroids. 国内成立合资公司 – 在中国成立合资实验室或合资生产基地 – 合作对象:国外制药企业、研发公司、有技术或产品的专家或团 队 – 合作项目:妇科、麻醉科新药,激素产品新剂型、新技术,生物 技术和产品 Global Talent Recruiting Plan (Thousand-Talents Scheme) • Xianju Pharma is collaborating with the Family Planning Commission to build a biopharma R&D platform for hereditary diseases and rare diseases. • Seeking talents and experts who will lead efforts to establish the R&D platform. 仙琚千人计划项目合作 • 仙琚与国家计生委合作打造基于遗传疾病、罕见病的生物制药研 发平台 • 为平台引进国千人才及国千后备人才 Global Talent Recruiting Program (Thousand-Talents Scheme) • Xianju Pharma has started to attract top talents since 2011 • One oversea talent has been recruited and won approval as Expert of National Thousand-Talent Scheme in 2012 • The second expert has been recruited and is waiting for final approval in 2013 仙琚千人计划项目 • 仙琚从2011年开始为平台引进国千人才及国千后备人才 • 2012年成功引进获批准一名国千专家。 • 2013年引进一名正等待最终批准 Qualifications for Thousand-Talent Scheme Experts PhD degree obtained oversea, under the age of 55 in principle. To be able to work in China for at least 6 months a year and must meet one of the following qualifications: • Professor or equivalent at top universities and research institutes; • Professionals and management personnel holding senior positions in wellknown international companies and financial institutions; • Entrepreneurs who possess independent intellectual property rights or master core technologies, have overseas experience in startups and are familiar with related industries and international rules; • Other high-level innovative talents urgently needed in China. “千人计划”引进条件 一般应在海外取得博士学位,原则上不超过55岁,引进后每年在国内工作一般不少于6个 月,并符合下列条件之一: • 在国外著名高校、科研院所担任相当于教授职务的专家学者; • 在国际知名企业和金融机构担任高级职务的专业技术人才和经营管理人才; • 拥有自主知识产权或掌握核心技术,具有海外自主创业经验,熟悉相关产业领域和国 际规则的创业人才; • 国家急需紧缺的其它高层次创新创业人才。 Landscape of Xianju 仙居风光 Cliffs of Jingxing 景星岩 Thank you !