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JP 摩根-中国-医疗保健行业-中国医疗保健:PD1与PD-L1行业-53-109页.pdf
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中国医疗保健行业正在经历一场由量变到质变的转型,尤其在生物医药领域,特别是PD-1/PD-L1单克隆抗体(mAB)市场的发展趋势尤为显著。这一转变受到一系列有利监管政策的推动,以及患者对创新药物可及性的提高。PD-1/PD-L1抑制剂作为肿瘤免疫疗法的重要组成部分,已成为癌症治疗的新焦点。
PD-1和PD-L1是免疫系统中的两个关键分子,它们参与了肿瘤细胞逃避免疫监视的机制。PD-1/PD-L1抗体通过阻断这一信号通路,恢复免疫细胞对肿瘤细胞的攻击能力,从而达到治疗癌症的效果。在中国,这个市场预计将以每年28%的速度增长,到2030年市场规模将达到799亿元人民币(约116亿美元),为众多参与者提供了广阔的发展空间。
报告中提到了四家在中国生物药领域具有代表性的公司:上海君实(覆盖评级为超配,目标价HK$37)、CStone(超配,HK$18)、 BeiGene(超配,HK$93(H) US$155(N))以及Innovent(超配,HK$33)。这些公司在生物医药领域的综合平台和丰富的产品线被认为是成功的关键因素。
上海君实和CStone是新兴的生物科技公司,专注于开发创新疗法,包括PD-1/PD-L1抑制剂。BeiGene是一家全球性的生物科技公司,在肿瘤治疗领域拥有广泛的管线产品,其PD-1抑制剂已经在全球范围内取得显著成果。Innovent则以其在肿瘤免疫治疗领域的研发实力和多元化产品组合而知名。
中国生物医药市场的快速发展主要源于以下几个方面:1) 国家对创新药的支持政策,如加快药品审批流程、提供资金支持等;2) 患者对高质量医疗需求的增加,尤其是对肿瘤等严重疾病的有效治疗方案;3) 技术进步,如基因测序、生物信息学分析等,推动了新药研发的效率和成功率。
然而,尽管市场潜力巨大,但也存在挑战,如高昂的研发成本、严格的监管环境、市场竞争激烈等。因此,企业需要持续投入研发,提升创新能力,同时加强与国内外合作伙伴的合作,以降低风险并加速产品商业化进程。
中国的PD-1/PD-L1市场正在快速发展,这为投资者和医药企业带来了巨大的机遇。随着监管政策的不断完善和医疗创新的持续推动,预计这一领域的竞争将更加激烈,也将催生出更多的市场领导者。投资者应充分考虑研究报告提供的信息,并结合其他因素做出投资决策。
Asia Pacific Equity Research
03 May 2019
China Healthcare Sector
Biotech 101: China’s PD1/PD-L1 Sector
Healthcare
Ling Wang
AC
(852) 2800 8599
ling.wang@jpmorgan.com
Bloomberg JPMA LWANG <GO>
Leon Chik, CFA
(852) 2800-8590
leon.hk.chik@jpmorgan.com
David XY Li
(852) 2800-8546
david.xy.li@jpmorgan.com
Sherry Yin
(852) 2800-8681
sherry.yin@jpmorgan.com
Christine Wang
(852) 2800-8528
christine.qy.wang@jpmorgan.com
Alex Tso, CFA
(852) 2800-0496
alex.tso@jpmorgan.com
J.P. Morgan Securities (Asia Pacific) Limited
See page 105 for analyst certification and important disclosures, including non
-
US analyst disclosures.
J.P. Morgan does and seeks to do business with
companies covered in its research reports. As a result, investors should be aware that the
firm may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report
as only a single factor in
making their investment decision.
www.jpmorganmarkets.com
Within China’s Pharmaceutical industry, we believe early signs of a shift from
volume-driven to innovation-driven growth are emerging. We expect this
trend to intensify, driven by favorable regulatory policies and improved
patient access to innovative drugs. We believe leading this wave is the market
for biologics oncology treatment/the emerging PD-1/PD-L1 monoclonal
antibody (mAB) market. We see this space growing 28% p.a to Rmb79.9bn
(or US$11.6bn) revenues by 2030; big enough for multiple winners riding this
wave. We expand our coverage of the biologics space; initiating coverage on
Shanghai Junshi (OW, HK$37) and CStone (OW, HK$18) and assuming
coverage on BeiGene (OW, HK$93(H) US$155(N)) and Innovent (OW,
HK$33). All have integrated platforms and broad pipeline, which we think are
keys to success.
Fast growing China biologics market offers significant opportunities.
The China biologics market is at an early stage. Eight of the top 10 drugs in
the USA are Biologics, versus two in China. With the market (excl. TCM)
still dominated by generic products, we expect strong growth for the
biologics market driven by a supportive regulatory environment, improved
reimbursement, and increasing demand for novel drugs, including biologics
and targeted therapies.
Strong growth expected for China’s PD-1/PD-L1 mAB market. The
global PD-1/PD-L1 mAB market has grown rapidly since the launch of the
first PD-1 inhibitor in 2014 (US$10bn revenues in 2018); while China's PD-
1/PD-L1 mAB market has just begun to emerge. We project the China’s PD-
1/PD-L1 market to reach Rmb79.9bn (or US$11.6bn) revenue by 2030, a
28% CAGR. Longer run, we expect domestic players to dominate market
share given their pricing advantage over (MNCs) and increased clinical data.
Opportunity to buy into Pioneers early: BeiGene, CStone, Innovent and
Shanghai Junshi are top players in the space. We view these stocks as
compelling opportunities to access the fast growing China biologics market.
The PD-1/PD-L1 mABs of these four companies are expected to be among
the first five to be introduced to the market among the domestic players. We
project the combined market share of the top 5 companies (including
Hengrui's (OW, covered by Leon Chik) PD-1 mAB) at peak to be over 50%
among the domestic players. These companies also have strong drug
development platform for sustained growth and future innovations.
Investment risks. A high growth rapidly evolving sector, like China
biotechnology, comes with uncertainties. In the intermediate term, we
believe execution risks, clinical, regulatory and marketing risks/pricing
pressure are key risks. The space is also in the early stage of
commercialization. News rather than earnings is the stock driver, downside
risks are development setbacks potentially exacerbated without an earnings
cushion.
China Biotech Coverage
Name
Ticker
R
ec
PT
BeiGene (HK)
6160 HK
OW
HK$93
BeiGene (US)
BGNE
OW
US$155
CStone
2616 HK
OW
HK$18
Innovent
1801 HK
OW
HK$33
Junshi
1877 HK
OW
HK$37
Source: Bloomberg, J.P. Morgan estimates
2
Asia Pacific
Equity Research
03 May 2019
Ling Wang
(852) 2800 8599
ling.wang@jpmorgan.com
Table of Contents
Executive Summary .................................................................3
Four recent Hong Kong Biotech IPOs – how do they stand
among the international peers ................................................6
Overview of China oncology market.......................................8
China biologics market ............................................................8
Biopharmaceutical market in China is still at an early stage and expects to have
strong growth ..........................................................................................................9
Strong industry tailwind for the biotechnology industry in China ...........................10
PD-1 and PD-L1 mAbs market overview...............................12
Mechanism of action .............................................................................................12
Key characteristics of PD-1/PD-L1 therapy ...........................................................12
Anti-PD-1 and PD-L1 mAbs are expected to become backbone therapy for cancer
treatment...............................................................................................................14
Global anti PD-1/PD-L1 market landscape.............................................................14
Competitive landscape in PD-1/PD-L1 mAB market in China................................14
Clinical trials under development for large indications...........................................15
Projections of PD-1/PD-L1 market size in China ...................................................16
Investment risks .....................................................................17
Companies ..............................................................................20
Beigene.................................................................................................................21
CStone Pharmaceuticals ........................................................................................39
Innovent Biologics (1801) .....................................................................................62
Shanghai Junshi Biosciences .................................................................................79
3
Asia Pacific
Equity Research
03 May 2019
Ling Wang
(852) 2800 8599
ling.wang@jpmorgan.com
Executive Summary
We are expanding our coverage of the China biologics industry. We are initiating
coverage on Shanghai Junshi (1877 HK - OW) and CStone (2616HK- OW) and
assuming coverage on BeiGene (6160 HK/BGNE US) and Innovent (1801 HK -
OW). As pioneers in the China’s biopharmaceutical industry, we believe these
companies provide good exposure to the fast growing China biologics market. The
PD-1/PD-L1 mABs of these four companies are expected to be among the first five
to be introduced to the market among the domestic players, and we expect these
companies to gain meaningful market share in this market. These companies also
have a strong drug development platform that enables sustained growth and future
innovations, driven by both organic growth and external partnerships.
Figure 1: Stock relative performance
Source: Bloomberg.
Fast growing China biologics market offers significant opportunities for
domestic and multi-national players
We expect strong growth for the China biologics market driven by a supportive
regulatory environment for innovative products, improved patient
access/reimbursement and huge demand for novel therapies. Within a broader trend
in China’s Pharmaceutical industry towards therapeutic drugs from more traditional
medications, we believe early signs of a shift from volume driven to innovation
driven growth are emerging. As an important component of innovative drugs, the
biologics market is still at a very early stage in China. Compared to the global level,
China lags in biologics innovation, with the majority of the market share (excluding
TCM) currently still dominated by generic products, thereby creating substantial and
sustainable opportunities for players developing innovative biologics.
70
80
90
100
110
120
130
140
150
160
170
2616 HK Equity 1801 HK Equity 6160 HK Equity 1877 HK Equity BTK Index
Key glossary
mAB – monoclonal antibodies
NMPA – National Medical Products
Administration (former CFDA)
NRDL - National Reimbursement Drug List
PD-1 – Programmed death protein 1
PD-L1 – Programmed death ligand 1
4
Asia Pacific
Equity Research
03 May 2019
Ling Wang
(852) 2800 8599
ling.wang@jpmorgan.com
Figure 2: Market growth is shifting towards therapeutics - Trend by category
Source: BeiGene Company Report & IQVIA
Our model projects PD-1/PD-L1 mAB market in China to reach Rmb79.9bn (or
US$11.6bn) revenue by 2030, big enough to support multiple winners
Immuno-oncology therapies (IOs) are expected to become the backbone therapies for
a wide variety of tumors due to their distinctive characteristics (broad efficacy &
good safety). While the global PD-1/PD-L1 inhibitors market has been growing
rapidly since the launch of the first anti-PD-1 MAB in 2014, and has already reached
over US$10bn revenues in 2018, China's PD-1/PD-L1 mAB market has just begun
emerging. Our market model projects the China PD-1/PD-L1 mABs market, if
successfully developed, to reach Rmb79.9bn (or US$11.6bn) revenue by 2030,
driven by increasing new cancer cases, improving national reimbursement (NRDL)
of innovative drugs & commercial insurance coverage, and potentially improving
efficacy by novel combinations. Over the long run, with the increased body of
clinical data from domestic PD-1/PD-L1 mABs and pricing advantage, we expect the
domestic players to take significant market share, while products from MNCs are
likely to be reserved for high-end patients with premium ability to pay.
Strong industry tailwind
The growth of the China biopharmaceutical industry has been fueled by increased
spending in the life sciences sector and the Chinese government’s favorable policies
to attract talent from overseas. Recently China’s regulatory environment has become
increasingly favorable for innovative drugs that address unmet medical needs by
significantly accelerating the new drug evaluation/approval process. Although
currently the efforts in boosting the Chinese biotech industry by the government have
not fully translated into biologics innovations (to the level of western countries), we
believe the efforts have created a strong basis for future innovation in the region. In
fact, we expect the four companies, although they are currently focused on fast
follow-ons and/or biosimilars, to rapidly develop and manufacture innovative
biologics once their R&D platform is upgraded and novel pipelines are established.
Investment risks
Generally speaking, the future of a high growth sector like China biotechnology,
which is full of changing opportunities, is associated with many uncertainties. In the
near to intermediate term, we believe execution risks, clinical, regulatory and
marketing risks as the key risks in investing in biopharmaceutical companies in
China. The China biopharmaceutical industry has, since inception, been driven by
favorable policy support by the Chinese government, and hence along with huge
5
Asia Pacific
Equity Research
03 May 2019
Ling Wang
(852) 2800 8599
ling.wang@jpmorgan.com
opportunities come significant risks. In our view, over the longer term, the main risk
in investing in the China biopharmaceutical industry lies in the uncertainties
surrounding the policies and macroeconomic factors. Additionally, the US/China
trade war might also impact the sustainable growth of the industry since
collaborations between Chinese companies and innovative biotech companies and
top academic centers in the US are likely an important source of future innovations.
The space is also in early stage of commercialization. News rather than earnings are
the key stock driver, with downside risks from development setbacks potentially
exacerbated without an earnings cushion.
Table 1: Stock performance (1M, 3M, YTD)
Stock performance
1M
3M
YTD
BeiGene
-
5%
-
4%
-
11%
CStone
-
11%
17%
17%
Innovent
-
16%
20%
4%
Junshi
5%
49%
32%
MSCI China index
0.1%
10%
28%
NYSE ARCA Biotech index (BTK)
-
10%
-
5%
10%
Source: Bloomberg.
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