从中国首创到全球首创之路 - ascletis · 2020. 10. 14. · 2 三大疾病领域....
TRANSCRIPT
-
歌礼制药有限公司从中国首创到全球首创之路2020年10月
-
2
三大疾病领域
病毒性肝炎非酒精性脂肪性肝炎 艾滋病
自2018年于香港交易所上市以来,歌礼成功地从一个单一的丙肝平台升级为三大
疾病领域、技术多元化的综合性平台。歌礼目前拥有三个商业化产品和十一个在
研产品(其中七个为内部研发)。
-
3
病毒性肝炎慢性丙肝
慢性乙肝靶点 产品/候选药物 Pre-IND IND Approval Ⅰ期临床 Ⅱ期临床 Ⅲ期临床 上市申请 上市
Licensed From/内部研发 权益区域
干扰素受体 派罗欣®
(聚乙二醇干扰素alfa-2a)中国大陆
程序性细胞死亡配体1(PD-L1) ASC22 大中华区
未披露 候选药物 内部研发 全球
法尼醇X受体(FXR) ASC42 内部研发 全球
靶点 产品/候选药物 Pre-IND IND Approval Ⅰ期临床 Ⅱ期临床 Ⅲ期临床 上市申请 上市Licensed From/
内部研发 权益区域
NS3/4A 戈诺卫®
(达诺瑞韦) 大中华区
NS5A 新力莱®
(拉维达韦) 大中华区
双靶点复方制剂 ASC18 内部研发 大中华区
NS5B ASC21 大中华区
-
4
为中国1000万丙肝患者提供全面的治疗方案
全口服丙肝治疗方案(RDV/DNV 治疗方案) : 于2020年7月获得中国国家药品监督管
理局(NMPA)批准上市
ASC18: 一日一片的全口服复方制剂
首个由中国本土企业研发的复方制剂丙肝完整治愈方案
Ⅲ期临床试验数据:两种药物单方制剂联合给药,具备泛基因型抗病毒活性,治愈
率(SVR12)>95%
DNV: 戈诺卫® (达诺瑞韦) RDV:新力莱® (拉维达韦)
-
5
研发能力和执行效率:戈诺卫®从IND获批到NDA获批历时33个月
2015年9月IND 获批
2018年6月NDA 获批
2015年10月首例受试者入组一期临床试验
2016年1月首例患者入组二期临
床试验
2016年6月首例患者入组三期临床试验
2017年1月递交滚动新药申请
2018年2月滚动递交三期临床试验报告
1个月
仅33个月
公司 (靶点) IND 获批时间 NDA 获批时间 IND到NDA 获批时长 (月)
歌礼 (HCV NS3/4A) 2015年9月 2018年6月 33 百时美施贵宝 (HCV NS3/4A and 5A) 2013年6月 2017年6月 48
-
6
研发能力和执行效率:新力莱®从IND获批到NDA获批历时50个月
2016年5月IND 获批
2016年7月首例受试者入组一
期临床试验
2017年5月首例患者入组二/三期临床试验( 共425 名患者)
2018年8月提交上市申请
2015年12月首例患者入组台湾二期临床
试验
2016年6月
2020年7月NDA 获批
-
7
中国本土企业开发的首个1类靶向丙肝创新药,打破外资企业在重大传染性疾病领域的垄断
戈诺卫®是中国本土企业开发的首个1类丙肝DAA创新药
从临床试验获批到新药上市获批
33个月 12周完整疗程治愈率97%
临床受试者人数3000+
-
8
SVR12 (%)
97 9396
59
RDV+SOF Epclusa
非肝硬化 肝硬化
1017
3942
102105
5153
406410
8282
GT3:SVR12(%)
99 96100 97 95
87
GT1a GT1b GT2 GT3 GT4 GT6
9697
2728
22
153158
284298
1315
首个由中国本土企业开发的全口服、无干扰素的丙肝治愈方案
新力莱®为同类最佳的泛基因型丙肝NS5A抑制剂,2020年7月获批上市。在中国已经完成的II/ III期临床试验
结果显示,经过12周治疗,RDV/DNV治疗方案在基因1型非肝硬化患者中治愈率(SVR12)达99%。
RDV+SOF方案对多种基因型疗效显著
数据来源:(1)DNV+RDV中国II/III期临床研究;(2)RDV+SOF马来西亚、泰国II/III期临床研究;(3)SOF/VEL(Epclusa)中国III期临床研究。
DNV: 戈诺卫® (达诺瑞韦) RDV:新力莱® (拉维达韦)SOF: 索磷布韦
-
9
歌礼HBV临床治愈攻略
基石药物:已上市的派罗欣®和通过皮下注射的PD-L1抗体ASC22
将派罗欣®与内部研发的针对新靶点的候选药物相结合
将PD-L1抗体ASC22与内部研发的针对新靶点的候选药物相结合
将派罗欣®或PD-L1抗体ASC22与行业领军企业的候选药物合作
siRNA药物
HBV入胞抑制剂
FXR激动剂
治疗性疫苗
-
10
派罗欣® (聚乙二醇干扰素α-2a注射液),于2002年获
批上市,用于治疗成人慢性乙型肝炎和丙型肝炎。全球
上市18年,超过115个国家和地区获准使用,惠及250
万病毒性肝炎患者,发表相关文献3986篇。
20.7%
31.3%
15.0%
5%
10%
15%
20%
25%
30%
35%
New Switch研究 瑞金团队研究 香港研究
NA经治患者HBsAg清除率
58.7%
49.4% 50.0%
10%
20%
30%
40%
50%
60%
70%
New Switch研究 瑞金团队研究 香港研究
NA经治优势患者HBsAg清除率
派罗欣® :慢乙肝患者追求临床治愈的重要治疗方案
1、New switch研究:Hu P, et al. J Clin Transl Hepatol. 2018;6:25-34.2、瑞金团队研究:Ren PP, et al. Hepatology, 2019, AASLD2019(Abstracts (poster 466)).3、香港研究:Chan HLY, et al. J Viral Hepat, 2019, 26(1): 126-135.
-
11
PD-L1抗体疗法对抗慢性乙肝的核心机制
ASC22(KN035)可以通过抑制PD-1/PD-L1通路,重建T细胞免疫功能,从而抑制乃至消除
HBV。
1. Peng G, et al. PD-1 upregulation is associated with HBV-specific T cell dysfunction in chronic hepatitis B patients. Mol Immunol. 2008;45(4):963-70.2. B Ye, et al.T-cell exhaustion in chronic hepatitis B infection: current knowledge and clinical significance. Cell Death Dis. 2015 Mar 19;6:e1694.
PD-1/PD-L1 interaction leads to T cell
exhaustion
——Persistent HBV infection
Blockade of PD-1/PD-L1 pathway restores T cell
function
——Elimination of HBV
-
12
HBV临床治愈: PD-1 抑制剂: Opdivo (纳武单抗)
Gane, EASL 2017
纳武单抗: 已上市的用于治疗实体器官肿瘤和淋巴瘤,抗PD-1单克隆抗体
概念性试验证明了PD-1 抗体能清除HBV表面抗原并在停药后得以维持
Study Week
纳武单抗 0.3 mg/kg
∆H
BsA
g fr
om B
asel
ine
(Log
10 IU
/mL)
0 1 2 3 4 6 8 12 16 20 24
• 十位患者中一位HBV表面抗原完全清除并且停药后疗效维持
• 十位患者中一位HBV表面抗原在第八周达到最低点,但之后反弹
• 十位患者中一位HBV表面抗原下降达到中等幅度
-
13
HBV临床治愈:全球首创皮下注射PD-L1 抗体
全球首创
阻断PD-1/PD-L1通路可以
有效提高特异性T细胞功能
最佳的乙肝免疫疗法
仅皮下注射的PD-1 / PD-L1抗体
已进入后期临床开发
表现出良好的安全性
中、美、日三国开展多项临床试验,包
括在中国开展的两项验证性试验,入组
癌症患者超过1000名
差异化特性
• 可皮下注射
• 常温下稳定
ASC22是一种全球首创的PD-L1抗体免疫疗法,有望为临床治愈乙肝带来重大突破。
-
14
HBV临床治愈: 皮下注射PD-L1抗体ASC22 vs 静脉注射PD-L1抗体
公司 罗氏 默克 阿斯利康 歌礼
通用名/代号 Atezolizumab Avelumab Durvalumab ASC22(KN035)
作用靶点 PD-L1 PD-L1 PD-L1 PD-L1
剂量 1200 mg/3 weeks 800mg/2 weeks 10mg/kg/2 weeks 1-2.5mg/kg/1 week
给药方式 静脉注射 静脉注射 静脉注射 皮下注射
适应症局部晚期或转移性尿
路上皮癌;转移性非小细胞肺癌
成人和12岁以上儿童转移性默克尔细胞癌
(MCC)患者;局部晚期或转移性尿
路上皮癌患者
局部晚期或转移性尿路上皮癌;
不可切除,III期非小细胞肺癌(NSCLC)
慢性乙肝
1、ASC22(KN035)对比已上市的PD-L1抗体,剂量更低,给药方式安全便捷;2、ASC22是首个已进入后期临床开发的皮下注射的PD-1 / PD-L1抗体;3、ASC22已在中、美、日三国开展多项临床试验,包括在中国开展的两项验证性试验,入组癌症患者超过1000名。
-
15
ASC22 慢性乙型肝炎Ⅱ期临床研究设计
CHB患者Ⅱa期研究 (N=9)
CHB患者Ⅱb期研究(N=150)
安全性评估
ASC22三个剂量组的单次给药PK/PD (n=9)
ASC22 剂量1 +NAs
(n=60)
ASC22 剂量2+NAs
(n=60)
NAs
(n=30)
治疗周期: 12周 or 24周
CHB:Chronic HBV Infection, 慢性乙型肝炎病毒感染PK:Pharmacokinetic, 药代动力学 PD=Pharmacodynamics, 药效动力学Nas: Nucleoside Analogues 核苷类似物
-
16
非酒精性脂肪肝病人群:3.14亿非酒精性脂肪肝炎患者:4,826万
NASH 市场规模及产品线一览
FASN: fatty acid synthase,脂肪酸合成酶
非酒精性脂肪肝病人群:0.85亿非酒精性脂肪肝炎患者:1,730万
非酒精性脂肪肝病人群:2.44亿非酒精性脂肪肝炎患者:3,281万2016
非酒精性脂肪肝病人群:1.01亿非酒精性脂肪肝炎患者:2,700万2030
C. Estes et al., J HEP 2018 (69): 896–904
靶点 产品/候选药物 Pre-IND IND Approval Ⅰ期临床 Ⅱ期临床 Ⅲ期临床 上市申请 上市Licensed From/
内部研发 权益区域
脂肪酸合成酶(FASN) ASC40 大中华区
甲状腺激素β受体(THR-beta) ASC41 内部研发 全球
法尼醇X受体(FXR) ASC42 内部研发 全球
-
17
ASC40, 全球首创用于治疗NASH的口服FASN抑制剂
非酒精性脂肪肝炎(NASH):百亿美元市场,至今尚无上市产品
改善重要代谢生物标志物
肝脏脂肪合成随药剂量增加而降低24%-73%
减少新生肝脂肪合成 降低总肝脏脂肪
临床作用机制证明
抑制肝脂肪合成
抗纤维化
抗炎症
C. Estes et al., J HEP 2018 (69): 896–904
-
18
与ACC抑制剂不同, FASN抑制剂的应用不会导致血浆中甘油三酯的升高
ACC 抑制剂导致丙二酰辅酶A和PUFAs的降低, 但是 PUFAs 的降低导致血浆中甘油三酯的升高
FASN 抑制剂只阻断棕榈酸酯的合成,但是没有参与降低PUFA的通路,因此没有引起血浆中甘油三酯升高
FASN InhibitionACC Inhibition
ACC
Acetyl-CoAGS-0976MK-4074PF-1304
FASN
Low PUFA levels activatepathways that increase VLDL transport from the liver – thereby increasing plasma triglycerides
Essential fatty acids (dietary )
Polyunsaturated fatty acids (PUFAs)
ACC
Acetyl-CoA
Malonyl-CoAFASN
Polyunsaturated fatty acids (PUFAs)
Essential fatty acids (dietary )
Malonyl-CoA Palmitate(Liver fat)
ASC40
Palmitate(Liver fat)
-
19
与其他 Ⅱ/Ⅲ期临床NASH候选药物比较, ASC40 (TVB2640)Ⅱ期数据具有优势
去除安慰剂效应后,肝脏脂肪含量降低≥ 30%的患者比例
Rohit Loomba et al. Gastroenterology. 2018 Nov;155(5):1463-1473.e6; Lucas, KJ et al. 2019. Late-breaking Abstracts at AASLD. Boston, Massachusetts; Harrison SA et al. Lancet. 2019;394(10213):2012-2024. doi:10.1016/S0140-6736(19)32517-6
Ⅱ期临床(FASCINATE-1)研究共
入组99名美国患者,初步数据显示,
ASC40(TVB-2640)显著降低了
肝脏脂肪含量(该试验的主要疗效
终点),在50 mg剂量组中应答率
为61%(17/28)。
1728
药物 安慰剂ASC40 (TVB-2640) Sagimet/歌礼 FASN 50 mg 12 60.7 11.1 49.6 副作用极小
Firsocostat 吉利德 ACC 20 mg 12 47.8 15.4 32.4 甘油三酯
Tropiflexor 诺华 FXR 200 ug 12 64 20 44 低密度脂蛋白胆固醇 ,瘙痒
Resmetirom Madrigal THR-β 80 mg 36 74.4 29.4 45 腹泻,恶心
候选药物 公司 靶点 剂量 周期 安全性肝脏脂肪含量降低≥30%的
患者比例, %去除安慰剂效应后,肝脏脂肪含量降低≥ 30%的患
者比例, %
Sheet1
Drug CandidateCompanyTargetDoseWeeks≥ 30% liver fat reduction responder rate, %Placebo adjusted ≥ 30% liver fat reduction responder rate, %Side effects
drugPlacebo
ASC40 (TVB2640)Sagimet/AscletisFASN50 mg1260.711.149.6minimal
FirsocostatGileadACC20 mg1247.815.432.4TG
TropiflexorNovartisFXR200 ug12642044LDL-C , pruritus
ResmetiromMadrigalTHRβ80 mg3674.429.445diarrhea,nausea
候选药物公司靶点剂量周期肝脏脂肪含量降低≥30%的患者比例, %去除安慰剂效应后,肝脏脂肪含量降低≥ 30%的患者比例, %安全性
药物安慰剂
ASC40 (TVB-2640)Sagimet/歌礼FASN50 mg1260.711.149.6副作用极小
Firsocostat吉利德ACC20 mg1247.815.432.4甘油三酯
Tropiflexor诺华FXR200 ug12642044低密度脂蛋白胆固醇 ,瘙痒
ResmetiromMadrigalTHR-β80 mg3674.429.445腹泻,恶心
-
20
ASC41
前体药物(ASC41)具有肝脏靶向性,其活性成分(ASC41-A)对THR-β具有选择性
两个NASH动物模型中,在剂量为1/10的MGL-3196的条件下,ASC41对肝脂肪变性、炎症和纤维化均有相同程度的改善
高活性和高选择性的THR-β激动剂,预计每天给药一次,每次小于10毫克
专有技术开发的口服片剂,常温下稳定,在比格犬中的暴露量与口服溶液的暴露量相同
预计将在2020年底获得在LDL-C大于110mg/dL的健康志愿者中的Ⅰ期安全性、药代和初步疗效(LDL-C)的顶线数据( Topline data )
-
21
ASC42
一种新型高效选择性非甾类法尼醇X受体(FXR)激动剂
美国IND于2020年10月获批
在两个NASH动物模型中,ASC42表现出对肝脏脂肪变性、炎症和纤维化的显著改善
专有技术开发的口服片剂,常温下稳定
-
22
艾滋病
我们正在拓展产品管线
用免疫疗法进行功能性治愈
治疗
预防
-
23
品牌建立和市场研究
患者研究及分析
提高丙型肝炎和乙型肝炎认知度
约1,000家医院位于中国丙肝和乙肝最流行的地区 约6,000位肝炎领域的专家和关键意见领袖 已与19家经销商签订分销协议,建立全国分销商网络
品牌策略网络覆盖资深团队
约135人商业化团队,五大职能部门:包括医学事务、销售、市场策略、市场准入、渠道/分销
总监及以上管理层在上述代表性公司有超过10年丙肝和乙肝领域的相关工作经验
全国首单销售
19 天2018年
3 个月
戈诺卫®
以学术推广为核心的商业化能力
获新药证书 获GMP证书
6月8日 6月14日 6月27日
获批3个月后进入天津市基本医疗保险,至今已进入成都和浙江基本医疗医保
-
24
行业规范 生产基地从设计、建设到
运行均严格遵循最严苛的cGMP规范
品质保障 广泛采用国际高端设备和
先进生产技术,确保每一颗药品的高品质
国际水准 来自跨国药企的生产技术人
员确保我们的生产质量管理体系保持国际水准
产能保障 充足产能为持续推出的创新
药物产业化奠定基础,保障临床用药供应
热熔挤出机
以品质为核心的制造能力
-
25
全球合作
-
26
总结
过去两年,歌礼成功地从一个单一的丙肝平台升级为三大疾病领域、技术多元化的综合性平台
病毒性肝炎: 1)戈诺卫® /新力莱®全口服丙肝治疗方案的商业化推广; 2)派罗欣®用于慢乙肝临床治愈的
商业化推广; 3)开发乙肝临床治愈的具有重大突破的疗法
非酒精性脂肪性肝炎:在全球范围内开发针对脂肪酸合成酶(FASN)、甲状腺激素受体ß (THR-ß)及
法尼醇X受体(FXR)这三个不同靶点的新型候选药物
艾滋病:扩大现有的治疗、预防和功能性治愈组合
未来两年,歌礼对已有的病毒性肝炎、脂肪性肝炎和艾滋病三大疾病领域的研发、商务拓展、
商业化的投入会更多、更快,同时拓展新的疾病领域
公司约30亿元人民币的现金储备和产品销售收入为公司后续的研发、商业化产品的管线升级和新疾病
领域的拓展提供了有力的支撑。
-
27
Disclaimer The documents, opinions and materials presented and distributed in the presentation (collectively, the “Document”), which were prepared by Ascletis Pharma Inc. (the “Company”) together with its subsidiaries and affiliates (collectively, the “Group”),
are provided to you solely for your exclusive use and information in connection with a proposed investment and are not for public dissemination. The Document is not prepared by Morgan Stanley Asia Limited, Goldman Sachs (Asia) L.L.C. and China MerchantsSecurities (HK) Co., Limited (collectively, the “Joint Sponsors”), nor any of their respective affiliates, controlling persons, directors, officers, partners, employees, agents, advisors or representatives. You fully understand that the Document is being made availableon a confidential basis and subject to the following provisions, to a limited number of recipients for the sole purpose of providing information to assist them in deciding whether they wish to proceed with a further investigation of the Company. The contents ofthis Document have not been reviewed by any regulatory authority in any jurisdiction. The distribution of this Document in certain jurisdictions may be restricted by law, and the recipients into whose possession this Document comes should inform themselvesabout, and observe such restrictions. By accessing this Document, you are agreeing (i) that you have read and agree to comply with the contents of this notice and disclaimer and (ii) to maintain absolute confidentiality regarding the information disclosed in thisDocument.
This Document has not been independently verified and is not intended to form the basis of any investment decision. It does not constitute an offer or invitation to sell, or any solicitation of any offer to subscribe for or purchase any securities in anyjurisdiction in which the making of such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction or would not otherwise be in compliance with the laws and regulations of such jurisdiction, andnothing contained herein shall form the basis of any investment decision, contract or commitment whatsoever. Any decision to purchase securities of the Company in any public or private offering should be made solely on the basis of the prospectus and/orinternational offering circular to be prepared by the Company in relation to any such contemplated offering together with any supplementary pricing information. This Document contains no information or material which may result in it being deemed (1) to be aprospectus within the meaning of section 2(1) Companies (Winding Up and Miscellaneous Provisions) Ordinance (Chapter 32 of the Laws of Hong Kong) (the “Companies Ordinance”), or an advertisement in relation to a prospectus or proposed prospectus orextract from or abridged version of a prospectus within the meaning of section 38B of the Companies Ordinance or an advertisement, invitation or document containing an advertisement or invitation falling within the meaning of section 103 of the Securities andFutures Ordinance (Chapter 571 of the Laws of Hong Kong) (the “Securities and Futures Ordinance”) or (2) in Hong Kong to have effected an offer to the public without compliance with the laws of Hong Kong or being able to invoke any exemption availableunder the laws of Hong Kong, and is subject to material change without notice.
The securities of the Company have not been and will not be registered under the U.S. Securities Act 1933, as amended (the “U.S. Securities Act”), or under the laws of any state of the United States. This Document does not constitute or form a part of anyoffer or solicitation to purchase or subscribe for securities in the United States and is not for distribution and may not be distributed, directly or indirectly, in or into the United States (including its territories and possessions, any state of the United States and theDistrict of Columbia). The securities of the Company will not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to the registration requirements of the U.S. Securities Act. There will be no public offer ofthe Company’s securities in the United States.
This Document and the information contained herein as well as information presented orally or otherwise are strictly confidential and must be treated as such. No part of this Document or its contents may be copied or reproduced, or redistributed orpassed on, directly or indirectly, to any other person in any manner or published, in whole or in part, for any other purpose. By accessing this Document, you are deemed to represent to the Company and the Joint Sponsors and their respective affiliates,controlling persons, directors, offices, partners, employees, agents, advisors or representatives that you are, and any customers you represent are either (i) a "qualified institutional buyer" within the meaning of Rule 144A of the U.S. Securities Act, or (ii) outside theUnited States. You also represent that you are, and any customers you represent are “professional investors” described in Part I of Schedule 1 to the Securities and Futures Ordinance and any subsidiary legislation thereunder (including but not limited to theSecurities and Futures (Professional Investor) Rules (Chapter 571D of the Laws of Hong Kong)).To the extent you purchase the securities of the Company, you will be doing so pursuant to either Rule 144A or Regulation S or another exemption from registrationunder the U.S. Securities Act. Neither this Document nor any copy of it may be taken or transmitted into or distributed, directly or indirectly, in the United States. Neither this Document nor any copy of it may be taken or transmitted into Canada or distributed orredistributed in Japan or to any resident thereof. Upon request, the recipient will promptly return this Document and all information made available in connection with the proposed investment, without retaining any copies.
The information in this Document has been provided by the Company. This Document does not purport to be comprehensive or to contain all the information that a recipient may need in order to evaluate the Group. No representation, warranty orundertaking, express or implied, is given and, so far as is permitted by law, no responsibility or liability is accepted by any person (for the avoidance of doubt, including but not limited to, the Company and the Joint Sponsors and their respective affiliates,controlling persons, directors, officers, partners, employees, agents, advisors or representatives of any of the foregoing), with respect to the accuracy, reliability, correctness, fairness or completeness of this Document or its contents or any oral or writtencommunication in connection with the proposed investment. In particular, but without limitation, no representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any assumptions, projections, targets,estimates, forecasts or any forward-looking statements contained in this Document. Each of the Company and the Joint Sponsors and their respective affiliates, controlling persons, directors, officers, partners, employees, agents, advisors or representatives of anyof the foregoing assumes no obligation to update or otherwise revise these forward-looking statements for new information, events or circumstances that occur subsequent to such dates. None of the Company and the Joint Sponsors and any of their respectiveaffiliates, controlling persons, directors, officers, partners, employees, agents, advisors or representatives of any of the foregoing shall have any liability (in negligence or otherwise) in respect of the use of, or reliance upon, the information contained herein by youor any person to whom the information herein is disclosed.
In furnishing this Document, the Company and the Joint Sponsors and their respective affiliates undertake no obligation to provide any additional information or to update this Document or any additional information or to correct any inaccuracies whichmay become apparent. This Document does not create an obligation on the Company or the Joint Sponsors or any of their respective affiliates to consider any offer. The provision of the information contained herein shall not be or be taken as any form ofcommitment on the Company, the Joint Sponsors, any of their respective affiliates or on you to proceed with the proposed placing or offering of securities in the Company.
The Company reserves the right to negotiate with one or more prospective investors at any time and to enter into a definitive agreement for the sale for the financing of this transaction without prior notice to the other prospective investors. The Company,the Joint Sponsors and their respective affiliates each also reserves the right, without advance notice, to change the procedure or to terminate negotiations at any time prior to the entry into of any binding contract for the proposed investment.
The Joint Sponsors or their affiliates are acting for the Company and not the recipient of this Document and the receipt of this Document by any recipient is not to be taken as constituting the giving of investment advice by the Joint Sponsors or theiraffiliates to that recipient, nor to constitute a customer or client relationship between the recipient and the Joint Sponsors or any of their affiliates. Accordingly, the Joint Sponsors or any of their affiliates will not be responsible to the recipient for providingprotections afforded to their customers or clients or advising the recipient in relation to the proposed investment.
You acknowledge and represent to the Company and the Joint Sponsors and their respective affiliates, controlling persons, directors, officers, partners, employees, agents, advisors or representatives that you are a professional investor, that you have theknowledge, experience and capability to conduct your own assessment of the Company and its securities and that you have conducted and will conduct your own investigation with respect to the Company and its securities and have obtained or will obtain yourown independent advice relating to any investment in the securities of the Company.
All enquiries or requests for additional information in connection with this Document should be submitted or directed to the Joint Sponsors. Management of the Company should not be contacted directly under any circumstances in connection with thisDocument and any unauthorized contact may result in termination of negotiations in relation to the proposed investment.
幻灯片编号 1三大疾病领域病毒性肝炎为中国1000万丙肝患者提供全面的治疗方案研发能力和执行效率:戈诺卫®从IND获批到NDA获批历时33个月研发能力和执行效率:新力莱®从IND获批到NDA获批历时50个月幻灯片编号 7首个由中国本土企业开发的全口服、无干扰素的丙肝治愈方案歌礼HBV临床治愈攻略派罗欣® :慢乙肝患者追求临床治愈的重要治疗方案PD-L1抗体疗法对抗慢性乙肝的核心机制HBV临床治愈: PD-1 抑制剂: Opdivo (纳武单抗)HBV临床治愈:全球首创皮下注射PD-L1 抗体HBV临床治愈: 皮下注射PD-L1抗体ASC22 vs 静脉注射PD-L1抗体幻灯片编号 15NASH 市场规模及产品线一览ASC40, 全球首创用于治疗NASH的口服FASN抑制剂与ACC抑制剂不同, FASN抑制剂的应用不会导致血浆中甘油三酯的升高与其他 Ⅱ/Ⅲ期临床NASH候选药物比较, ASC40 (TVB2640)Ⅱ期数据具有优势ASC41ASC42艾滋病以学术推广为核心的商业化能力幻灯片编号 24全球合作总结Disclaimer