"中国医疗保健：PD1与PD-L1行业分析"

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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》是一份关于中国医疗保健行业的研究报告，着重探讨了中国的PD1与PD-L1行业，主要内容包括生物科技101、中国PD1/PD-L1行业等方面。报告由JP摩根亚太股票研究团队完成，联系人包括Ling Wang、Leon Chik、David XY Li、Sherry Yin、Christine Wang和Alex Tso，他们的联系方式也在报告中列出。报告强调了PD1/PD-L1作为中国医疗保健行业的重要组成部分，提到了该行业的关键数据和趋势。另外，报告还包含了分析师的认证和重要披露信息，以及JP摩根与涵盖在研究报告中的公司进行业务往来的情况。因此，投资者在阅读该报告时应当意识到，该公司可能存在可能影响独立性的利益冲突。总的来说，《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》是一份完整的研究报告，对中国医疗保健行业及其PD1与PD-L1行业进行了深入的分析和探讨，为投资者提供了宝贵的信息和参考。

Asia Pacific

Equity Research

03 May 2019

Ling Wang

(852) 2800 8599

ling.wang@jpmorgan.com

NSCLC

Hengrui May-17 Phase III camrelizumab + pemetrexed and carboplatin in non-squamous NSCLC

BeiGene Nov-17 Tislelizumab vs. Docetaxel in 2L or 3L NSCLC (Global trial)

Junshi Apr-18 Phase II: JS001 + chemo vs. chemo alone in 2L EGFR+ NSCLC after TKI failure

Innovent Jul-18 Phase III Sintilimab + Pemetrexed/Platinum vs. Pemetrexed/Platinum in 1L non-squamous NSCLC

BeiGene Jul-18 Tislelizumab + chemo (platinum-pemetrexel) vs. chemo in non-Squamous NSCLC (China trial)

BeiGene Aug-18 Tislelizumab + chemo vs. chemo in stage IIIB or IV squamous NSCLC (China trial)

Innovent Sep-18 Phase III Sintilimab monotherapy in 2L squamous NSCLC

Innovent Sep-18 Phase III Sintilimab + gemcitabine and platinum in 1L squamous NSCLC

Cstone Oct-18 Phase III: CS1001 in Stage III NSCLC that has not progressed after prior concurrent/sequential chemo

Hengrui Nov-18 Phase III camrelizumab + carboplatin + paclitaxel in squamous NSCLC

Cstone Dec-18 Phase III: CS1001 + SOC in stage IV NSCLC

BeiGene Jan-19 Tislelizumab + cCRT followed by Tislelizumab vs. cCRT alone in 1L Stage III locally advanced, unresectable NSCLC (global trial)

Innovent Jan-19 Phase III Sintilimab + IBI305 + Chemotherapy (Pemetrexed ± Cisplatin) in EGFRm+ in TKI failure non-squamous NSCLC

Junshi Feb-19 Phase III: JS001 + chemo vs. chemo alone in 1L EGFR-wt NSCLC

Junshi May-19 Phase III: JS001 + Pemetrexed + Platinum vs. Pemetrexed + Platinum alone in EGFRm+ TKI resistant NSCLC

Innovent Phase III Sintilimab + Pemetrexed/cisplatin vs. Pemetrexed/cisplatin in 1L non-squamous NSCLC

BeiGene Jul-17 Pivotal Phase II Tislelizumab monotherapy (completed enrollment in 3Q18) in R/R UC patients

Junshi

Completed

enrollment Pivotal Phase II JS001 monotherapy in R/R UC patients

Source: Clinicaltrails.gov, company reports & J.P. Morgan research.

Projections of PD-1/PD-L1 market size in China

In China, there is a growing cancer patient population with tumors responsive to PD-

1/PD-L1 antibodies. According to Frost & Sullivan, the new cancer incidence in

China is estimated to be around 4.2 mn, of which ~3.4 mn patients are addressable by

PD-1/PD-L1 antibodies. Our model projects PD-1/PD-L1 market in China, if

successfully developed, to reach Rmb 79.9bn (or US$ 11.6bn) by 2030, growing at a

CAGR of over 27% from 2019-2030, big enough for multiple winners. We make the

following key assumptions:

 Innovent and Junshi already received their anti PD-1 approved in December

2019, and launched in 1Q19. We assume BeiGene and Hengrui’s products to

obtain approval and get launched in 2H19, although there is uncertainty

surrounding the approval of Hengrui’s anti PD-1 due to the drug properties. We

assume CStone and other key players to receive approval in 2021 and beyond.

 We expect the composite treatment rate in all tumor types to peak at ~20%. We

believe that top 5 players will likely take up over 50% of the market share by

patient number among the domestic players.

 The annual treatment cost of domestic pharmaceutical companies in China will

be approx. 50-70% of multinational brands. We expect an average ~10-15% price

erosion every year until large indications are included in NRDL.

 In the initial years, we assume MNC brands to capture the majority of the market

initially due to their perceived premium safety and efficacy profile; a first-mover

advantages in China and the relatively wide range of the indications approved.

Asia Pacific

Equity Research

03 May 2019

Ling Wang

(852) 2800 8599

ling.wang@jpmorgan.com

However, 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 MNCs’ products are likely to be

reserved for high-end patients. Based on our model, by 2030, domestic players

are expected to occupy 2/3 of the total sales whereas MNCs are expected to only

have 1/3% of the market share.

 The market share assumptions among domestic players will largely depend on a

number of factors: 1) evolving clinical profile (efficacy and safety) of the

molecule in large indications; 2) pricing strategy of the products; 3) the timing for

the drug to get approved / reimbursed in large indications; 4) the sale &

marketing capability of the team.

Investment risks

Generally speaking, the future of a high growth sector like China biotechnology,

which has many changing opportunities is by nature associated with many

uncertainties. In the near to intermediate term, we believe execution risks, clinical,

regulatory and marketing risks are the key risks of investing in biopharmaceutical

companies in China. Since the emergence of the China biopharmaceutical industry is

heavily driven by the China government’s favorable policy support, accompanied by

huge opportunity are significant risks. In our view, over the longer term, the main

risks in investing in the China biopharmaceutical industry are the uncertainties

surrounding the policies and macroeconomic factors. Additionally, the US/China

trade war may 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. More

specifically, investing in the companies are also subject to the following risks:

Clinical risk and regulatory risk

Drug development and clinical trials carry inherent risk. Potential negative data or

unexpected delays in these trials and clinical programs from other trials, as well as

potential delays in obtaining regulatory approval will generate significant downside

pressure for the shares. Among the four companies we cover, Junshi and Innovent’s

PD-1 mABs have obtained regulatory approval in their initial indications while

BeiGene and CStone’s lead compounds have not been approved. Additionally, all of

these PD-1/PD-L1 mABs are still being evaluated in multiple late stage clinical trials

in many expanded indications with much larger market opportunity than their initial

indications.

Commercial risk

The market opportunities of the PD-1/PD-L1 products and the companies’ other

products may not be as large as we expected. In China, since the government

reimbursement is likely the largest payor of the novel therapeutics, the pricing of

drugs is expected to drop order to be included in NRDL. So far, despite price being a

potential headwind in China, we see the discount pricing model as rational, given

that volume growth appears to be more than offsetting the price cuts.

For the PD-1/PD-L1 market, there will be competition with MNCs as well as

domestic players. In particular, if MNCs decide to drop the prices of their PD-1/PD-

L1 substantially, it would negatively impact the market opportunities of domestic

products. Additionally, Henrui's PD-1 mAB is under review by CDE. Currently there

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"中国医疗保健：PD1与PD-L1行业分析"

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