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1 本 研 究 报 告 仅 通 过 邮 件 提 供 给 国 投 瑞 银 国 投 瑞 银 基 金 管 理 有 限 公 司 使 用 1 SWS Research Co. Ltd is a subsidiary of Shenwan Hongyuan Securities. 99 East Nanjing Road, Shanghai Bringing China to the World 28 July 2015 Equalweight Unchanged Analyst Jill Wu A AXT645 wuyu@swsresearch.com 祸 兮, 福 之 所 倚 Pharmaceuticals: Sector outlook 史 上 最 严 药 品 临 床 数 据 自 查 7 月 22 日,CFDA 发 布 关 于 开 展 药 物 临 床 试 验 数 据 自 查 核 查 工 作 的 公 告, 决 定 对 1622 个 已 申 报 生 产 或 进 口 的 待 审 药 品 注 册 申 请 开 展 药 物 临 床 试 验 数 据 核 查 CFDA 用 最 严 谨 的 标 准 最 严 格 的 监 管 最 严 厉 的 处 罚 最 严 肃 的 问 责 四 个 最 严 来 作 为 此 次 自 查 核 查 的 要 求 2015 年 8 月 25 日 前, 申 请 人 应 提 交 电 子 版 自 查 报 告 申 请 人 自 查 发 现 临 床 试 验 数 据 存 在 不 真 实 不 完 整 等 问 题 的, 可 以 在 2015 年 8 月 25 日 前 向 CFDA 提 出 撤 回 注 册 申 请 CFDA 将 视 情 况 开 展 飞 行 检 查, 对 核 查 中 发 现 临 床 试 验 数 据 真 实 性 存 在 问 题 的 相 关 申 请 人,3 年 内 不 受 理 其 申 请 临 床 规 范 的 企 业 将 长 期 受 益 我 们 认 为, 此 次 药 品 临 床 数 据 自 查 是 CFDA 解 决 药 品 审 评 积 压 的 手 段 之 一 截 至 2014 年 底,CFDA 待 审 评 的 药 品 数 量 高 达 个 今 年 两 会 期 间,CFDA 官 员 承 诺 在 未 来 三 年 内 解 决 审 评 积 压 问 题 此 次 临 床 数 据 核 查 将 迫 使 临 床 不 合 格 的 品 种 退 出 申 请, 从 而 减 轻 CFDA 的 审 评 工 作 负 担 此 外, 国 内 药 品 注 册 存 在 大 量 的 重 复 申 报 截 至 2014 年 底, 待 审 的 化 药 ANDA 申 请 共 8713 个, 占 待 审 任 务 重 量 的 46.9%, 而 涉 及 的 活 性 成 分 仅 有 1061 个 我 们 注 意 到, 此 次 自 查 名 单 包 含 了 较 多 的 重 复 申 报 品 种, 例 如 苯 磺 酸 氨 氯 地 平 片 瑞 书 法 他 汀 钙 片 奥 硝 唑 片 等 部 分 重 复 申 报 的 品 种 的 退 出 将 有 助 于 缓 和 行 业 竞 争 状 况 然 而, 临 床 数 据 核 查 或 将 拖 慢 近 期 药 品 审 批 进 度 首 先, 企 业 需 要 花 费 大 约 1 个 月 的 时 间 完 成 临 床 数 据 自 查 工 作 其 次,CFDA 飞 检 工 作 的 完 成 时 间 存 在 不 确 定 性 我 们 预 计, 通 过 此 次 临 床 数 据 核 查 的 品 种 未 来 有 望 享 受 CFDA 的 优 先 审 评 然 而, 审 评 工 作 的 加 速 或 将 等 到 此 次 临 床 数 据 核 查 工 作 完 成 以 后 The company does not hold any equities or derivatives of the listed company mentioned in this report ( target ), but then we shall provide financial advisory services subject to the relevant laws and regulations. Any affiliates of the company may hold equities of the target, which may exceed 1 percent of issued shares subject to the relevant laws and regulations. The company may also provide investment banking services to the target. The Company fulfills its duty of disclosure within its sphere of knowledge. The clients may contact compliance@swsresearch.com for relevant disclosure materials or log into under disclosure column for further information. The clients shall have a comprehensive understanding of the disclosure and disclaimer upon the last page. 至 少 16 家 香 港 上 市 药 企 的 142 个 品 种 将 受 到 影 响 其 中, 中 国 生 物 制 药 (1177 HK) 和 石 药 集 团 (1093 HK) 受 到 的 影 响 最 大, 分 别 有 22 个 和 21 个 品 种 被 纳 入 临 床 数 据 自 查 清 单 其 他 受 影 响 较 大 的 企 业 包 括 国 药 控 股 (1099 HK,12 个 品 种 ) 罗 欣 药 业 (8058 HK,12 个 品 种 ) 东 瑞 制 药 (2348 HK,11 个 品 种 ) 等 我 们 认 为 大 企 业 具 有 相 对 严 格 的 临 床 试 验 管 控 制 度 并 且 委 托 相 对 规 范 的 CRO 供 应 商, 因 此 通 过 核 查 的 可 能 性 较 高 药 品 质 量 监 管 将 持 续 趋 严 我 们 注 意 到,CFDA 飞 行 检 查 的 执 行 力 度 在 今 年 有 显 著 提 高, 从 而 导 致 大 量 GMP 证 书 被 收 回 年 初 至 今, 已 经 有 63 张 GMP 证 书 被 CFDA 收 回 2015 年 7 月 8 日, CFDA 发 布 药 品 医 疗 器 械 飞 行 检 查 办 法, 将 飞 行 检 查 纳 入 CFDA 的 日 常 性 工 作, 该 办 法 将 于 今 年 9 月 1 日 起 执 行 我 们 认 为, 严 格 的 药 品 质 量 监 管 将 导 致 质 量 不 合 格 的 小 企 业 退 出 市 场, 从 而 提 升 药 品 制 造 行 业 的 进 入 门 槛, 提 升 行 业 集 中 度 Valuation table: Company Code Rating CSPC Pharma The United Laboratories Target price (HK$) +/- (%) PE (x) PB (x) 15E 16E 17E 15E 16E 17E 1093 HK O-PF HK BUY NT Pharma 1011 HK BUY Source: SWS Research

2 本 研 究 报 告 仅 通 过 邮 件 提 供 给 国 投 瑞 银 国 投 瑞 银 基 金 管 理 有 限 公 司 使 用 2 Investment Highlights: On 22 July, the China Food and Drug Administration (CFDA) ruled that drug makers seeking to register new products (a total of 1,622 new drug applications on the list) must conduct self-verifications of clinical trial data by 25 August Clinical trial rules. Applicants are free to cancel their new drug applications if they find their clinical data to be untrue or incomplete. The CFDA will conduct random inspections (hereafter referred to as flight inspections) on applicants that find no problem during their clinical trials. For those whose clinical data are found to be untrue during the flight inspection will be banned from new drug applications for the next three years. Self-verification benefits qualified applicants. We expect this round of self-inspection to help eliminate unqualified drug applications, thus alleviating pressure for the CFDA amid a significant number of new drug applications and easing competition among pharmaceutical manufacturers. Uncertain schedule for flight inspections. It takes around one-month for applicants to finish the self-inspection process, while the timeline of the CFDA s flight inspection remains uncertain. We believe applicants that pass initial inspection may reap the advantages of prior approval. However, we anticipate that the approval process of applicants included in the self-inspection list may come to a halt until full inspections are completed by the CFDA. A total of 16 H-shares are affected. In Hong Kong, 16 listed companies with at least 142 applications will be affected. Among all H-shares, Sino Biopharmaceutical (1177:HK) and CSPC Pharmaceutical Group (1093:HK) are the most impacted with 22 and 21 applications on the list, respectively. However, we see minimal risk for large firms during the inspection process given their typically strict internal controls and subcontract clinical trials with large clinical research organisations (CROs). Tighter quality controls will benefit large firms. Given intensified flight inspections, at least 63 GMP certificates have been cancelled by the CFDA since beginning of the year. On 8 July, the CFDA issued flight inspections for medicine and medical device firms, which will be implemented on 1 September. We believe that small firms with weak internal quality controls will be forced out of the market while large firms will consolidate more market share thanks to higher entry barriers. Our top picks remain The United Laboratories (3933:HK) and CSPC Pharmaceutical (1093:HK). Please refer to the last page for important disclosures Page 1

3 本 研 究 报 告 仅 通 过 邮 件 提 供 给 国 投 瑞 银 国 投 瑞 银 基 金 管 理 有 限 公 司 使 用 3 Strict inspection of clinical trial data On 22 July, the CFDA announced a list containing 1,622 new drug applications and required related applicants to complete self-inspection of the clinical data before 25 August Applicants are free to cancel their new drug applications if they find their clinical data unreal or incomplete. CFDA will conduct random inspection (so called "flight inspection") of the applicants claiming no problem in their clinical trial data. For applicants whose clinical data were found unreal during the flight inspection, they will be banned from new drug applications for the next three years. Chemical drugs are the main focus. Of the total drugs in the self-inspection list, 1,283, or 79% of the applications are chemical drugs. The remaining 15% and 6% are traditional Chinese medicine (TCM) and biological drugs, respectively. In addition, 58% of the applications are class 1-5 new drugs while 31% are class 6 generic drugs and 11% are imported drugs. Moreover, 84% of the applications are submitted between 2011 and Figure 1: Applications included in the selfinspection list by drug category Figure 2: Applications included in the selfinspection list by application type Biological drugs, 6.3% TCM, 14.6% Class 6 generic drugs, 31.0% Imported drugs, 10.5% Chemical drugs, 79.1% Class 1~5 new drugs, 58.4% Source: CFDA, SWS Research Please refer to the last page for important disclosures Page 1

4 本 研 究 报 告 仅 通 过 邮 件 提 供 给 国 投 瑞 银 国 投 瑞 银 基 金 管 理 有 限 公 司 使 用 4 Figure 3: Applications included in the self-inspection list by year Source: CFDA, SWS Research Large players to benefit Self-inspection benefits qualified applicants. CFDA is struggling with enormous amount of drug applications. In 2014, CFDA accepted 8,868 new drug applications while completed merely 5,261 reviews. By end-2014, number of pending applications reached 18,597. During the Two Meetings in March 2015, officials of CFDA stated that they will try to eliminate the drug approval backlog within the next three years. We expect this round of inspection will cause revocation of unqualified applications, which will alleviate the work load for CFDA. Figure 4: Review tasks for CFDA Source: CFDA, SWS Research Accepted Pending Completed Please refer to the last page for important disclosures Page 2

5 本 研 究 报 告 仅 通 过 邮 件 提 供 给 国 投 瑞 银 国 投 瑞 银 基 金 管 理 有 限 公 司 使 用 5 Meanwhile, CFDA has received large amount of duplicate applications. For instance, by end-2014, 8,713 chemical drug ANDAs which involved 1,061 active ingredients were pending for review, accounting for 46.9% of the total amount of pending tasks. We notice that many duplicate applications are included in the selfinspection list. We expect some unqualified duplicate applications to be recalled, which will help to ease the competition among drug manufacturers. Figure 5: Duplicate applications in the self-inspection list Generic name in Chinese Generic name in English Number applications 苯 磺 酸 氨 氯 地 平 片 Amlodipine Besylate Tablet 19 瑞 舒 伐 他 汀 钙 片 Rosuvastatin calcium tablet 17 奥 硝 唑 片 Ornidazole tablet 14 多 潘 立 酮 片 Domperidone Tablet 12 拉 米 夫 定 片 Lamivudine tablet 11 硫 酸 氢 氯 吡 格 雷 片 Clopidogrel Bisulfate tablet 11 Source: CFDA, SWS Research Nevertheless, the inspection may cause some delay in new drug approval. It takes about one-month for applicants to finish the self-inspection. Moreover, the timeline of CFDA s following flight inspection is uncertain. Although we think applicants who pass the inspections may enjoy prior approval, the approval process of applications included in the self-inspection list may come to a halt until the inspections are completed. At least 142 applications of 16 HK-listed companies are affected. Sino Biopharmaceutical Ltd. (1177 HK) with 22 applications in the list and CSPC Pharmaceutical Group (1093 HK) with 21 applications in the list are most affected among HK-listed companies. Other listcos with large number of applications in the list are Sinopharm Group (1099 HK, 12 applications), Shandong Luoxin Pharmaceutical Group (8058 HK, 12 applications), and Dawnrays Pharmaceutical Holdings (2348 HK, 11 applications). In the appendix, we listed the application number and generic name of the listcos applications included in the selfinspection list. We see little risks for large players to fail in the inspection as they usually have strict internal control over clinical trials or subcontract part of their clinical trial work to large clinical research organizations (CROs). Figure 6: Number of applications included in the self-inspection list for HK-listed companies Please refer to the last page for important disclosures Page 3

6 本 研 究 报 告 仅 通 过 邮 件 提 供 给 国 投 瑞 银 国 投 瑞 银 基 金 管 理 有 限 公 司 使 用 Source: CFDA, SWS Research CFDA s continuous focus on drug quality control will benefit large players. Besides of the inspection of clinical trial data, we notice that CFDA is making other efforts on drug quality control. We found that CFDA has intensified its frequency of fly inspections in As a result, at least 63 GMP certificates have been cancelled by CFDA since beginning of this year. On 8 July 2015, CFDA issued the method of flight inspection for medicines and medical devices, to be implemented from 1 September This implies that flight inspection will be a regular work for CFDA and pharmaceutical manufacturers will face tightening quality regulations. We believe that small players with loose internal quality control will be forced out of the market while large players will consolidate more market share thanks to higher entry barrier. Please refer to the last page for important disclosures Page 4

7 本 研 究 报 告 仅 通 过 邮 件 提 供 给 国 投 瑞 银 国 投 瑞 银 基 金 管 理 有 限 公 司 使 用 7 Appendix Figure 7: Drug applications of HK-listed companies needs self-inspection Application number Generic name in Chinese Generic name in English Sino-biopharm (1177 HK) CXHS 利 马 前 列 素 片 Limaprost tablet CXHS 利 多 卡 因 凝 胶 膏 Lidocaine gel CXHS 盐 酸 青 藤 碱 缓 释 胶 囊 Sinomenine hydrochloride extended release capsule CYHS 塞 来 昔 布 胶 囊 Celecoxib capsule CXHS 氢 溴 酸 达 非 那 新 缓 释 片 Darifenacin extended release tablet CXHS 羟 乙 基 淀 粉 (130/0.4) 醋 酸 钠 林 格 注 射 液 Hydroxyethyl starch sodium acetate ringer's Injection CXHS 吡 非 尼 酮 片 Pirfenidone tablet CXZS 赤 苷 脉 通 注 射 液 Chiganmaitong injection CYHS 硫 酸 氢 氯 吡 格 雷 片 Clopidogrel bisulfate tablet CYHS 丙 泊 酚 中 / 长 链 脂 肪 乳 注 射 液 Propofol Medium and Long Chain Fat Emulsion Injection CYHS 拉 米 夫 定 片 Lamivudine tablet CXHS 噻 康 唑 软 膏 Tioconazole cream CXHS 来 曲 唑 胶 囊 Letrozole capsule CXHS 盐 酸 帕 洛 诺 司 琼 注 射 液 Palonosetron hydrochloride injection CXHS 环 索 奈 德 粉 吸 入 剂 Ciclesonide powder for Inhalation CXHS 环 索 奈 德 粉 吸 入 剂 Ciclesonide powder for Inhalation CXHS 注 射 用 盐 酸 苯 达 莫 司 汀 Bendamustine Injection CXHS 注 射 用 多 立 培 南 Doripenem injection CXHS 奈 拉 滨 注 射 液 Nelarabine injection CXHS 注 射 用 多 黏 菌 素 E 甲 磺 酸 钠 Polymyxin E injection CXHS 注 射 用 头 孢 替 坦 二 钠 Cefetecol disodium injection CXHS 富 马 酸 替 诺 福 韦 二 吡 呋 酯 片 Tenofovir Disoproxil Fumarate tablet CSPC Pharma (1093 HK) CXZS 金 刚 藤 软 胶 囊 Jingangteng soft capsule CXHS 阿 托 伐 他 汀 钙 分 散 片 Atorvastatin calcium dispersing tablet CXHS 奥 拉 西 坦 颗 粒 Oxiracetam granule CXHS 非 布 司 他 片 Febuxostat tablet CXHS 非 布 司 他 片 Febuxostat tablet CXHS 注 射 用 盐 酸 头 孢 唑 兰 Cefozopran hydrochloride injection CXHS 盐 酸 伊 伐 布 雷 定 片 Ivabradine hydrochloride tablet CXHS 盐 酸 伊 伐 布 雷 定 片 Ivabradine hydrochloride tablet CYHS 阿 卡 波 糖 片 Acarbose tablet CYHS 缬 沙 坦 胶 囊 Valsartan capsule CYHS 阿 托 伐 他 汀 钙 片 Atorvastatin calcium tablet CYHS 苯 磺 酸 氨 氯 地 平 片 Amlodipine Besylate Tablet CYHS 苯 磺 酸 氨 氯 地 平 片 Amlodipine Besylate Tablet CYHS 瑞 舒 伐 他 汀 钙 片 Rosuvastatin calcium tablet CYHS 瑞 舒 伐 他 汀 钙 片 Rosuvastatin calcium tablet CYHS 瑞 舒 伐 他 汀 钙 片 Rosuvastatin calcium tablet CYHS 非 洛 地 平 缓 释 片 Felodipine extended release tablet CYHS 氯 沙 坦 钾 片 Losartan potassium tablet CXHS 注 射 用 硫 酸 头 孢 噻 利 Cefoselis sulfate injection CXHS 阿 莫 氨 溴 片 Ambroxol amoxicillin tablet CXZS 清 肝 化 瘀 胶 囊 Qinggan Huayu capsule Please refer to the last page for important disclosures Page 5

8 本 研 究 报 告 仅 通 过 邮 件 提 供 给 国 投 瑞 银 国 投 瑞 银 基 金 管 理 有 限 公 司 使 用 8 Shanghai Pharma (2607 HK) CXHS 盐 酸 马 尼 地 平 片 Manidipine hydrochloride tablet CXHS 依 普 利 酮 片 Eplerenone tablet CYHS 阿 司 匹 林 缓 释 片 Aspirin extended release tablet CXZS 调 经 活 血 颗 粒 Tiaojinghuoxue granule CXZS 灯 盏 花 素 分 散 片 Breviscapine dispersing tablet X 注 射 用 参 麦 冻 干 粉 Shenmai powder injection X 注 射 用 参 麦 冻 干 粉 Shenmai powder injection CXHS 盐 酸 贝 那 普 利 氢 氯 噻 嗪 片 Benazepril hydrochloride and hydrochlorothiazide tablet CYHS 磷 酸 利 美 尼 定 片 Rilmenidine phosphate tablet CYHS 氯 沙 坦 钾 氢 氯 噻 嗪 片 Losartan potassium and hydrochlorothiazide tablet CXHS 米 氮 平 片 Mirtazapine tablet CYHS β- 环 糊 精 美 洛 昔 康 微 丸 胶 囊 β-cyclodextrin meloxicam capsule CXHS 乌 苯 美 司 口 腔 崩 解 片 Ubenimex orally disintegrating tablet CYHS 匹 维 溴 铵 片 Pinaverium bromide tablet CXHS 甲 磺 酸 雷 沙 吉 兰 片 Rasagiline mesilate tablet Sinopharm (1099 HK) CXHS 法 罗 培 南 钠 胶 囊 Faropenem sodium capsule CXHS 法 罗 培 南 钠 颗 粒 Faropenem sodium granule CXHS 法 罗 培 南 钠 片 Faropenem sodium tablet CXHS 头 孢 丙 烯 胶 囊 Cefprozi capsule CXHS 头 孢 丙 烯 颗 粒 Cefprozi granule CXHS 头 孢 特 仑 新 戊 酯 干 混 悬 剂 Cefteram pivoxil suspension CXHS 瑞 普 拉 生 片 Revaprazan tablet CXHS 头 孢 地 尼 干 混 悬 剂 ( 无 糖 型 ) Cefdinir suspension (sugar free) CXHS 愈 酚 伪 麻 氢 可 酮 口 服 溶 液 Guaifenesin pseudoephedrine and hydrocodone oral solution CYHS 头 孢 克 肟 干 混 悬 剂 ( 无 糖 型 ) Cefixime suspension (sugar free) CYHS 头 孢 克 肟 分 散 片 Cefixime dispersing tablet CYHS 头 孢 克 肟 分 散 片 Cefixime dispersing tablet Luoxin Pharma (8058 HK) CXHS 盐 酸 阿 比 朵 尔 分 散 片 Arbidol hydrochloride dispersing tablet CXHS 醋 氯 芬 酸 肠 溶 颗 粒 Aceclofenac enteric coatel granule CXHS 罗 红 霉 素 氨 溴 索 干 混 悬 剂 Roxithromycin ambroxol suspension CXHS 瑞 舒 伐 他 汀 钙 胶 囊 Rosuvastatin calcium capsule CXHS 盐 酸 头 孢 卡 品 匹 酯 片 Cefcapene pivoxil hydrochloride tablet CXHS 头 孢 克 洛 溴 己 新 颗 粒 Cefaclor and bromhexine hydrochloride granule CXHS 替 吉 奥 胶 囊 TS-1 combination capsule CYHS 奥 硝 唑 片 Ornidazole tablet CYHS 头 孢 泊 肟 酯 干 混 悬 剂 Cefpodoxime proxetil suspension CYHS 头 孢 泊 肟 酯 干 混 悬 剂 Cefpodoxime proxetil suspension CYHS 拉 米 夫 定 片 Lamivudine tablet CYHS 硝 呋 太 尔 片 Nifuratel tablet Dawnrays Pharma (2348 HK) CXHS 头 孢 特 仑 新 戊 酯 干 混 悬 剂 Cefteram pivoxil suspension CXHS 头 孢 特 仑 新 戊 酯 胶 囊 Cefteram pivoxil capsule CXHS 瑞 舒 伐 他 汀 钙 片 Rosuvastatin calcium tablet CXHS 瑞 舒 伐 他 汀 钙 片 Rosuvastatin calcium tablet CXHS 瑞 舒 伐 他 汀 钙 片 Rosuvastatin calcium tablet CXHS 氨 氯 地 平 贝 那 普 利 片 (I) Amlodipine benazepril tablet CXHS 氨 氯 地 平 贝 那 普 利 片 (Ⅱ) Amlodipine benazepril tablet Please refer to the last page for important disclosures Page 6

9 本 研 究 报 告 仅 通 过 邮 件 提 供 给 国 投 瑞 银 国 投 瑞 银 基 金 管 理 有 限 公 司 使 用 9 CYHS 头 孢 丙 烯 干 混 悬 剂 Cefprozil suspension CYHS 头 孢 克 洛 缓 释 片 Cefaclor extended release tablet CYHS 麦 角 隐 亭 咖 啡 因 片 Dihydroergocryptine a mesilate and caffeine tablet CYHS 头 孢 布 烯 胶 囊 Ceftibuten capsule Sihuan Pharm (460 HK) CXHS 氯 沙 坦 钾 胶 囊 Losartan potassium capsule CXHS 注 射 用 兰 索 拉 唑 Lansoprazole injection CYHS 富 马 酸 比 索 洛 尔 片 Bisoprolol fumarate tablet CYHS 富 马 酸 比 索 洛 尔 片 Bisoprolol fumarate tablet CXHS 奥 拉 西 坦 葡 萄 糖 注 射 液 Oxiracetam glucose injection CXHS 奥 拉 西 坦 氯 化 钠 注 射 液 Oxiracetam sodium chloride injection CXHS 单 唾 液 酸 四 己 糖 神 经 节 苷 脂 钠 氯 化 钠 注 射 液 Monosialotetrahexosylganglioside sodium injection CXHS 单 唾 液 酸 四 己 糖 神 经 节 苷 脂 钠 氯 化 钠 注 射 液 Monosialotetrahexosylganglioside sodium injection CXHS 单 唾 液 酸 四 己 糖 神 经 节 苷 脂 钠 氯 化 钠 注 射 液 Monosialotetrahexosylganglioside sodium injection CXHS 米 屈 肼 注 射 液 Mildronate injection The United Laboratories (3933 HK) CYHS 阿 莫 西 林 胶 囊 Amoxicillin capsule CYHS 阿 莫 西 林 胶 囊 Amoxicillin capsule CXSS 甘 精 胰 岛 素 注 射 液 Insulin glargine injection CXHS 甲 磺 酸 帕 珠 沙 星 氯 化 钠 注 射 液 Pazufloxacin mesilate and sodium chloride injection CXHS 非 布 司 他 片 Febuxostat tablet CXHS 非 布 司 他 片 Febuxostat tablet CXHS 富 马 酸 替 诺 福 韦 二 吡 呋 酯 片 Tenofovir Disoproxil Fumarate tablet CYHS 头 孢 地 尼 胶 囊 Cefdinir capsule CYHS 富 马 酸 替 诺 福 韦 二 吡 呋 酯 片 Tenofovir Disoproxil Fumarate tablet China TCM (570 HK) CXHS 注 射 用 13 种 复 合 维 生 素 13 vitamins injection CXZS 黑 骨 藤 伸 筋 透 骨 喷 雾 剂 Heiguteng Shenjin Tougu spray CXZS 郁 枢 达 片 Yushuda tablet CXSS 人 免 疫 球 蛋 白 Human immunoglobulin CXSS 人 免 疫 球 蛋 白 Human immunoglobulin CXSS 乙 型 肝 炎 人 免 疫 球 蛋 白 Human Hepatitis B Immunoglobulin CXSS 乙 型 肝 炎 人 免 疫 球 蛋 白 Human Hepatitis B Immunoglobulin Guangzhou Baiyunshan Pharma (874 HK) CXHS 依 那 普 利 非 洛 地 平 缓 释 片 Enalapril felodipine extended release tablet CXHS 巴 洛 沙 星 片 Balofloxacin tablet CXHS 巴 洛 沙 星 胶 囊 Balofloxacin capsule JXHS % 脂 肪 乳 (OO)/5.5% 氨 基 酸 (15)/ 葡 萄 糖 (20%) 注 射 液 CYZS 养 阴 清 肺 糖 浆 Yangyinqingfei syrup CXZS 心 泰 片 Xintai tablet Fosun Pharma (2196 HK) Fat emulsion(10%)/amino acids(15)/glucose(20%) injection CYHS 双 氢 青 蒿 素 哌 喹 片 Dihydroartemisinin and piperaquine phosphate tablet CXHS 阿 戈 美 拉 汀 片 Agomelatine tablet CXHS 盐 酸 度 洛 西 汀 肠 溶 片 Duloxetine hydrochloride enteric coatel tablet CXHS 盐 酸 度 洛 西 汀 肠 溶 片 Duloxetine hydrochloride enteric coatel tablet CXHS 盐 酸 帕 洛 诺 司 琼 注 射 液 Palonosetron hydrochloride injection Livzon Pharma (1513 HK) CXHS 布 南 色 林 片 Blonanserin tablet CXHS 艾 普 拉 唑 肠 溶 片 Ilaprazole enteric coated tablet CXSS 吸 附 乙 型 脑 炎 灭 活 疫 苗 (Vero 细 胞 ) Japanese encephalitis vaccine Please refer to the last page for important disclosures Page 7

10 本 研 究 报 告 仅 通 过 邮 件 提 供 给 国 投 瑞 银 国 投 瑞 银 基 金 管 理 有 限 公 司 使 用 10 Lee's Pharm (950 HK) JXHS 盐 酸 丙 酰 左 卡 尼 汀 片 Propionyl-L-carnitine hydrochloride tablet JXHS 盐 酸 曲 唑 酮 缓 释 片 Trazodone hydrochloride extended release tablet JXHS 盐 酸 曲 唑 酮 缓 释 片 Trazodone hydrochloride extended release tablet Luye Pharma (2186 HK) CXHS 还 原 型 谷 胱 甘 肽 肠 溶 胶 囊 Glutathione enteric coated capsule CXZS 金 玉 康 胶 囊 Jinyukang capsule China Shineway Pharma (2877 HK) CXZS 当 归 苯 酞 软 胶 囊 Tang-Kuei phthalide soft capsule CXZS 金 柴 胶 囊 Jinchai capsule SSY Group (2005 HK) CXHS 平 衡 盐 冲 洗 液 Balanced salt irrigating solution CYHS 盐 酸 伐 昔 洛 韦 片 Valacyclovir hydrochloride tablet Source: CFDA, SWS Research Please refer to the last page for important disclosures Page 8

11 本 研 究 报 告 仅 通 过 邮 件 提 供 给 国 投 瑞 银 国 投 瑞 银 基 金 管 理 有 限 公 司 使 用 11 Information Disclosure: The views expressed in this report accurately reflect the personal views of the analyst. The analyst declares that neither he/she nor his/her associate serves as an officer of nor has any financial interests in relation to the listed corporation reviewed by the analyst. None of the listed corporations reviewed or any third party has provided or agreed to provide any compensation or other benefits in connection with this report to any of the analyst, the Company or the group company(ies). A group company(ies) of the Company confirm that they, whether individually or as a group (i) are not involved in any market making activities for any of the listed corporation reviewed; or (ii) do not have any individual employed by or associated with any group company(ies) of the Company serving as an officer of any of the listed corporation reviewed; or (iii) do not have any financial interest in relation to the listed corporation reviewed or (iv) do not, presently or within the last 12 months, have any investment banking relationship with the listed corporation reviewed. Undertakings of the Analyst I (We) am (are) conferred the Professional Quality of Securities Investment Consulting Industry by the Securities Association of China and have registered as the Securities Analyst. I hereby issue this report independently and objectively with due diligence, professional and prudent research methods and only legitimate information is used in this report. I am also responsible for the content and opinions of this report. I have never been, am not, and will not be compensated directly or indirectly in any form for the specific recommendations or opinions herein. Disclosure with respect to the Company The company is a subsidiary of Shenwan Hongyuan Securities. The company is a qualified securities investment consulting institute approved by China Securities Regulatory Commission with the code number ZX0065. Releasing securities research reports is the basic form of the securities investment consulting services. The company may analyze the values or market trends of securities and related products or other relevant affecting factors, provide investment analysis advice on securities valuation/ investment rating, etc. by issuing securities research reports solely to its clients. The Company fulfills its duty of disclosure within its sphere of knowledge. The clients may contact compliance@swsresearch.com for the relevant disclosure materials or log into for the analysts' qualifications,the arrangement of the quiet period and the affiliates shareholdings. Introduction of Share Investment Rating Security Investment Rating: When measuring the difference between the markup of the security and that of the market s benchmark within six months after the release of this report, we define the terms as follows: Trading BUY: Share price performance is expected to generate more than 20% upside over a 6-month period. BUY: Share price performance is expected to generate more than 20% upside over a 12-month period. Outperform: Share price performance is expected to generate between 10-20% upside over a 12-month period. Hold: Share price performance is expected to generate between 10% downside to 10% upside over a 12-month period. Underperform: Share price performance is expected to generate between 10-20% downside over a 12-month period. SELL: Share price performance is expected to generate more than 20% downside over a 12-month period. Industry Investment Rating: When measuring the difference between the markup of the industry index and that of the market s benchmark within six months after the release of the report, we define the terms as follows: Overweight:Industry performs better than that of the whole market; Equal weight: Industry performs about the same as that of the whole market; Underweight:Industry performs worse than that of the whole market. We would like to remind you that different security research institutions adopt different rating terminologies and rating standards. We adopt the relative rating method to recommend the relative weightings of investment. The clients decisions to buy or sell securities shall be based on their actual situation, such as their portfolio structures and other necessary factors. 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The Company does not ensure that this report fully takes into consideration of the particular investment objectives, financial situations or needs of individual clients. The Company strongly suggests the clients to consider themselves whether the opinions or suggestions herein are suitable for the clients particular situations; and to consult an independent investment consultant if necessary. Under no circumstances shall the information contained herein or the opinions expressed herein forms an investment recommendation to anyone. Under no circumstances shall the Company be held responsible for any loss caused by the use of any contents herein by anyone. Please be particularly cautious to the risks and exposures of the market via investment. Independent investment consultant should be consulted before any investment decision is rendered based on this report or at any request of explanation for this report where the receiver of this report is not a client of the Company. 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12 本 研 究 报 告 仅 通 过 邮 件 提 供 给 国 投 瑞 银 国 投 瑞 银 基 金 管 理 有 限 公 司 使 用 12 This report may be translated into different languages. The Company does not warrant that the translations are free from errors or discrepancies. This report is for distribution in Hong Kong only to persons who fall within the definition of professional investors whether under the Securities and Futures Ordinance (Chapter 571 of the laws of Hong Kong) (the SFO ) or the Securities and Futures (Professional Investor) Rules (Chapter 571D of the laws of the Hong Kong under the SFO). This report is for distribution in the United Kingdom only to persons who (i) have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) order 2001 (as amended) (the Order ) or (ii) are persons falling within Article 49(2)(a) to (d) ( High Net Worth Companies, Unincorporated Associations, etc ) of the Order (All such persons together being referred to as Relevant Persons ). This document is directed only at Relevant Persons. Other Persons who are not Relevant Persons must not act or rely upon this document or any of its contents. Distribution in Singapore If distributed in Singapore, this report is meant only for Accredited Investors and Institutional Investors as defined under Section 4A of the Securities and Futures Act of Singapore. If you are not an Accredited Investor or an Institutional Investor, you shall ignore the report and its contents. The Singapore recipients of the report are to contact the Singapore office of Shenwan Hongyuan Singapore Private Limited at , or in respect of any matters arising from, or in connection with, the report. Please refer to the last page for important disclosures Page 2