April 10, 2020

Biotech/Healthcare Status check on development of COVID-19 /treatments

Taehee Kim +822-3774-6813 [email protected]

Analysts who prepared this report are registered as research analysts in Korea but not in any other jurisdiction, including the U.S. PLEASE SEE ANALYST CERTIFICATIONS AND IMPORTANT DISCLOSURES & DISCLAIMERS IN APPENDIX 1 AT THE END OF REPORT. COVID-19 vaccines and treatments

Multiple pharmaceutical • Multiple projects have been launched to study the novel coronavirus. companies have begun • Government-commissioned research projects and large-scale funding (donations) should lead to technological improvements that aid development. working on vaccine - Bill Gates donated US$100mn to speed up the development process. development • Big pharmas working on vaccine development include Sanofi, Pfizer, Johnson & Johnson (J&J), and Eli Lilly. • Korean companies searching for vaccines include Celltrion, Genexine, and AbClon.

List of companies developing COVID-19 vaccines and treatments

Vaccines Treatments

Developer Technology Developer Technology

Sanofi Protein-based Eli Lilly, AbCellera Biologics Antibody

Pfizer, BioNTech RNA vaccine Takeda Pharmaceutical Antibody

J&J Viral vector Biogen, Vir Biotechnology Antibody

Moderna, NIH RNA vaccine NIH Antibody

CureVac RNA vaccine Regeneron Pharmaceuticals Antibody

Inovio Pharmaceuticals DNA vaccine Sorrento Therapeutics Fusion protein

Zydus Cadila DNA vaccine Vir Biotechnology, Alnylam siRNA

Generex Biotechnology, EpiVax Protein-based Sirnaomics siRNA

Sinopharm Group Vir Biotechnology, WuXi Biologics Antibody

Novavax, Emergent BioSolutions Protein-based Insilico Medicine Small molecule

BioNTech, Fosun Pharma RNA vaccine Enanta Pharmaceuticals Small molecule

Institut Pasteur Live Celltrion Antibody

Source: Mirae Asset Daewoo Research

2| Biotech/Healthcare Mirae Asset Daewoo Research COVID-19 vaccines and treatments

COVID-19 fears to ease • COVID-19 has had a devastating impact on the economy largely because of the absence of a vaccine/treatment. once vaccines or • Fears related to the virus will largely abate if vaccines and/or treatments are found. treatments are • So far, Moderna’s mRNA-1273 (vaccine candidate) and Gilead’s remdesivir (antiviral treatment) have shown the most promising results. successfully developed

Moderna’s share performance Gilead’s share performance

(US$) (US$) 90 40

80 30

70 20

60 10

50 0 1/19 4/19 7/19 10/19 1/20 4/20 1/19 4/19 7/19 10/19 1/20 4/20

Source: Bloomberg, Mirae Asset Daewoo Research Source: Bloomberg, Mirae Asset Daewoo Research

3| Biotech/Healthcare Mirae Asset Daewoo Research COVID-19 vaccines

Human trials • Among the various vaccine candidates, Moderna’s mRNA-1273 has made the most progress so far. for Moderna's vaccine • A phase 1 trial began on March 16th with 45 healthy adults. candidate have begun • The candidate was exempted from preclinical studies, which should not be an issue given that mRNA-1273 is already in phase 2 trials as a cytomegalovirus vaccine. • Phase 2 trials, for which samples are already being produced, could begin in a few months. • One of the biggest advantages of RNA vaccines is their mass production potential. The company has already started to build production facilities.

Moderna’s vaccine pipeline

Source: Moderna, Mirae Asset Daewoo Research

4| Biotech/Healthcare Mirae Asset Daewoo Research COVID-19 vaccines

Expectations on new • On April 6th, Inovio commenced a phase 1 trial of its COVID-19 vaccine INO-4800. The trial will enroll 40 healthy vaccine technologies adults, each of whom will receive two doses four weeks apart. • CureVac and Novavax have also shown progress in their development efforts. • Big pharmas that have launched vaccine development projects include J&J and GlaxoSmithKline (GSK). • While RNA vaccines and plant-based protein vaccines may not ultimately become the vaccine of choice for COVID- 19, we have high expectations for their use in future pandemics.

Vaccine pipeline by company

Company Item Vaccine type Status

Moderna mRNA-1273 RNA vaccine Phase 1 trial underway

Inovio INO-4800 DNA vaccine Preparing for phase 1 trial

CureVac - RNA vaccine Phase 1 trial in early Jun.

Novavax - Recombinant spike protein Phase 1 trial in May-Jun.

J&J - Non-self-replicating virus vector Preclinical underway

CSL/GSK - Protein vaccine Preclinical completed

Generex - Phase 1 trial in Jun.

Medicago Virus-like particles Plant-based protein vaccine Phase 1 trial in Jul.-Aug.

Altimmune NasoVAX Phase 1 trial in Aug.

Source: Mirae Asset Daewoo Research

5| Biotech/Healthcare Mirae Asset Daewoo Research COVID-19 treatments

Existing antiviral drugs • Existing antiviral drugs are being explored as treatments for COVID-19. being explored as • Korea: Kaletra and chloroquine are considered first-line therapies. potential COVID-19 • Japan: The anti-influenza drug Avigan is in use. Avigan was not effective in treating the H1N1 virus and failed in clinical trials as an Ebola treatment. treatments • China: Various treatments (e.g., Tamiflu and convalescent plasma collected from recovered COVID-19 patients) are being tested. • US: Remdesivir, an unapproved Ebola treatment, is being used to treat COVID-19 patients.

Antiviral drugs considered as potential COVID-19 treatments

Drug Developer Indication Notes

Lopinavir/ritonavir AbbVie HIV Recommended for use in Korea (Kaletra)

Chloroquine Generic Malaria Recommended for use in Korea

Influenza A Favipiravir (Avigan) Fujifilm Currently in use in Japan (H1N1)

Oseltamivir (Tamiflu) Generic Influenza Currently in use in China

Remdesivir Gilead Ebola virus Currently in use in the US

Not recommended as first-line Interferon-α Generic Hepatitis B therapy in Korea

Source: Mirae Asset Daewoo Research

6| Biotech/Healthcare Mirae Asset Daewoo Research COVID-19 treatments

Kaletra found not • On March 18, The New England Journal of Medicine published a Chinese research team’s paper on the use of the effective in treating anti-HIV drug Kaletra as a COVID-19 treatment. • The study found no clinical benefit from using Kaletra in adult patients with severe COVID-19. severe COVID-19 • In the study, 199 patients with COVID-19 were randomly assigned to receive either Kaletra in addition to standard care (n = 99) or standard care alone (n = 100); standard care consisted of antibiotics, respiratory support, renal replacement therapy, and extracorporeal membrane oxygenation.

Marginal difference in time to clinical improvement Mean change from baseline in SARS-CoV-2 viral RNA

Source: The New England Journal of Medicine , Mirae Asset Daewoo Research Source: The New England Journal of Medicine , Mirae Asset Daewoo Research

7| Biotech/Healthcare Mirae Asset Daewoo Research COVID-19 treatments

Chloroquine, the second • Chloroquine is the second most promising COVID-19 treatment, following remdesivir. most promising • Chloroquine has been used as an anti-malaria drug for more than 80 years. treatment for COVID-19 • President Trump called chloroquine a game changer, and the FDA issued an Emergency Use Authorization for the drug on March 28. • However, European regulators have not cleared the drug for treating COVID-19, citing lack of efficacy evidence. • About 10 Korean pharmaceutical companies produce chloroquine. Among them, listed companies are Crystal Genomics, BC World Pharm, and Shin Poong.

Chloroquine products available in Korea

Product Ingredient/strength Company Drug price Duroc Tab. 100mg Hydroxychloroquine sulfate 100mg PMG Pharm W177 Duroc Tab. 400mg Hydroxychloroquine sulfate 400mg PMG Pharm W323 Non- Malachlo Tab. Chloroquine phosphate 250mg Shin Poong reimbursable Non- Aruquin Tab. Hydroxychloroquine sulfate 200mg Unimed reimbursable Oxiklorin Tab. 100mg Hydroxychloroquine sulfate 100mg Elyson W174 Oxiklorin Tab. 300mg Hydroxychloroquine sulfate 300mg Elyson W309 Chlorquine Tab. 100mg Hydroxychloroquine sulfate 100mg Myungin Pharm W177 Chlorquine Tab. 400mg Hydroxychloroquine sulfate 400mg Myungin Pharm W323 Polanil Tab. 100mg Hydroxychloroquine sulfate 100mg LegoChem Pharma Export Polanil Tab. 200mg Hydroxychloroquine sulfate 200mg LegoChem Pharma Export Halrochrosin Tab. Hydroxychloroquine sulfate 100mg Hankook Korus Pharm Export Haloxin Tab. 100mg Hydroxychloroquine sulfate 100mg Hanlim Pharm W176 Haloxin Tab. 200mg Hydroxychloroquine sulfate 200mg Hanlim Pharm W246 Hydroquine Tab. 100mg Hydroxychloroquine sulfate 100mg Crystal Genomics Export Hydroquine Tab. 200mg Hydroxychloroquine sulfate 200mg BC World Pharm W247

Source: Mirae Asset Daewoo Research

8| Biotech/Healthcare Mirae Asset Daewoo Research COVID-19 treatments

Gilead’s remdesivir, the • Gilead’s remdesivir, an unapproved Ebola treatment, is the most promising candidate for COVID-19. most promising • The phase 2 trial of remdesivir (Ebola) was suspended due to low efficacy and enrollment issues. • The company initiated a large-scale phase 3 clinical study of remdesivir in China, the US, and Korea. candidate for COVID-19 • Treatment potential • 1) In January 2020, The New England Journal of Medicine published a successful case report in the US. • 2) In February 2020, Cell Research published an in-vitro study on remdesivir and chloroquine. - Of seven antiviral agents, remdesivir and chloroquine stand out in terms of efficacy and safety data.

Treatment potential based on in-vitro data

Drug EC50 (μM) CC50 (μM) SI

Remdesivir 0.77 >100 129.87

Chloroquine 1.13 >100 88.5

Rivbavirin 109.5 >400 3.65

Penciclovir 95.96 >400 4.17

Favipirvir 61.88 >400 6.46

Nafamostat 22.5 >100 4.44

Nitazoxanide 2.12 >35.53 16.76

Source: Cell Research, BioSpectator, Mirae Asset Daewoo Research

9| Biotech/Healthcare Mirae Asset Daewoo Research COVID-19 treatments

Gilead’s remdesivir, the • The Korea Research Institute of Chemical Technology (KRICT) has released interim results from its drug reinvention project investigating potential COVID-19 treatments. most promising • The KRICT is researching eight medications, including remdesivir, chloroquine, and Kaletra. candidate for COVID-19 • The active form of remdesivir outperformed the other drugs in terms of efficacy. Chloroquine was also found to be effective. • Gilead announced that it is working to quickly expand the production of remdesivir. • Through process improvements, the company has shortened the scale-up timeline from 9-12 months to 6-8 months.

Treatment potential based on in-vitro data

Image* CPE** Drug Indication

EC50(μM) CC50(μM) SI EC50(μM) CC50(μM) SI

Lopinavir HIV 19.2 50.1 2.5 >86.3 86.3 N.D.

Ritonavir HIV 32.2 56.4 1.8 >83.1 83.1 N.D.

Favipiravir Influenza >100 >100 N.D. >100 >100 N.D.

Chloroquine Malaria 8.9 >100 >11.2 11.9 >100 >8.4

Hydroxychloroquine Malaria 10.7 >100 >9.3 18.1 >100 >5.5

Remdesivir Ebola 7.9 >100 >12.7 1.3 >100 >76.6

Remdesivir (active form) Ebola 1.2 >100 >83.3 0.4 >100 >200

Rilpivirin HIV 9.8 >100 >10.2 >32.6 >32.6 N.D.

Notes: * Drug efficacy is defined as the rate of decline in virus levels in infected cells, when treated with a drug. ** Cytopathic effect: CPE uses a virus-induced cell death and measures the drug efficacy by the rate of reproduction of affected cells, when treated with a drug. Source: KRICT, Mirae Asset Daewoo Research 10| Biotech/Healthcare Mirae Asset Daewoo Research COVID-19 treatments

Positive outcomes of • Some COVID-19 patients are being given transfusions of plasma collected from recovered individuals, as such plasma therapy are plasma is believed to contain high levels of antibodies. • Recently, successful cases have been reported in China and Korea. In the US, Johns Hopkins University has begun reported in Korea and a phase 2 of a plasma therapy to treat COVID-19. abroad • While plasma therapy has a short development timeline, it is not suited for mass production. • One treatment session requires 6-7 liters of blood from recovered patients, who can donate only one unit of blood (320-400ml) at a time.

Improvement in pneumonia symptoms in patients Centrifuged plasma: Proteins, ions, and inorganic compounds treated with plasma therapy

Source: NCRAD, Mirae Asset Daewoo Research Source: Journal of Korean Medical Science, Mirae Asset Daewoo Research

11| Biotech/Healthcare Mirae Asset Daewoo Research Most anticipated R&D events and conference schedule

Major conferences in 2020 R&D events expected in 2020

Major conferences Details Company Details Hanmi 2Q: Initiation of phase 2 trial for triple agonist JPM Healthcare Conference Major healthcare investment symposium (1/13-1/16) 2Q: NDA filing for Oraxol ASCO-SITC Cancer immunotherapy symposium (2/6-2/8) 3Q: Completion of phase 1b trial for LAPS Glucagon 4Q: Completion of phase 1 trial for RAF inhibitor ENDO Endocrine Society (3/28-3/31) 4Q: US approval of Rolontis American Association for Cancer Research (4/27-4/28, Yuhan/ 2Q: Announcement of final data on independent phase 2 lazertinib AACR 6/22-6/24) Oscotec trial 2Q: Announcement of interim phase 1b data for lazertinib combo PES Pediatric Endocrinology Society (5/2-5/5) 3Q: Submission of approval application for lazertinib (Korea) Dong-A ST 2Q: Initiation of preclinical trial for MerTK inhibitor ASCO American Society of Clinical Oncology (5/29-6/2) 2Q: Completion of US phase 1b trial for DA-1241 EULAR European League Against Rheumatism (6/3-6/6) Green Cross 2Q: Announcement of interim phase 1b/2a data for GC1118 3Q: Approval for GreenGene F in China BIO USA Biotechnology Innovation Organization (6/8-6/11) 4Q: BLA filing for IVIG-SN 10% ADA American Diabetes Association (6/12-6/16) CKD 2Q: Announcement of phase 2 results for CKD-506 HanAll 2Q: Announcement of phase 2 top-line data for HL161 International Association for the Study of Lung Cancer IASLC Oscotec 4Q: Announcement of phase 2a results for SKI-O-703 (8/9-8/12) MedPacto 2Q: Announcement of phase 1b/2a results for vactosertib combo 4Q: Announcement of phase 2a results for vactosertib combo European Society for Pediatric Endocrinology (9/10- ESPE Bridgebio 3Q: Completion of US phase 2a trial for BBT-401 9/12) 3Q: Initiation of US phase 2 trial for BBT-877 ESMO European Society for Medical Oncology (9/18-9/22) OliX 3Q: Initiation of US phase 2 trial for OLX101 3Q: Filing of US IND application for phase 1 trial of OLX301A European Association for the Study of Diabetes (9/21- Qurient 3Q: Initiation of phase 2b trial for Q203 EASD 9/25) PharmAbcine 2Q: Announcement of invacimab/Keytruda phase 1b interim results Genexine 2Q: Announcement clinical trial results for Hyleukin-7 UEGW United European Gastroenterology Week (10/10-10/14) Alteogen 2Q: Announcement of phase 1 results for ALT-P7 2Q: Announcement of interim results from domestic phase 1/2a ACR American College of Rheumatology (11/6-11/10) NKMax trial for SNK01-N12a (NSCLC) SITC Society for Immunotherapy of Cancer (11/11-11/15) 2Q: Announcement of interim results from US phase 1 trial for SNK01-US01 (solid cancer) AHA American Heart Association (11/14-11/16) 2Q: Announcement of Pexa-Vec/Libtayo phase 1 trial interim SillaJen ASH American Society of Hematology (12/5-12/8) results Source: Mirae Asset Daewoo Research Source: Mirae Asset Daewoo Research

12| Biotech/Healthcare Mirae Asset Daewoo Research Investment strategy

Top picks: Yuhan and • For 2020, important events to watch include the American Society of Clinical Oncology (ASCO) meeting, clinical Celltrion study result announcements, and other R&D events. • Our top picks among major pharma/biotech players are Yuhan and Celltrion

Sector recommendation, top picks, and preferred stocks

Rating/stock Notes Market cap (Wbn) YTD return (%)

Top-tier

Three major out-licensing deals signed; poised for a re- Top pick Yuhan 3,276 3.6 rating as a new drug developer

Biosimilars

Top pick Celltrion New drug momentum to drive robust earnings growth 28,356 16.3

Source: Mirae Asset Daewoo Research

13| Biotech/Healthcare Mirae Asset Daewoo Research APPENDIX 1

Important Disclosures & Disclaimers 2-Year Rating and Target Price History

Company (Code) Date Rating Target Price Company (Code) Date Rating Target Price Yuhan(000100) Celltrion(068270) 04/10/2020 Buy 62,000 02/20/2020 Buy 260,000 01/21/2020 Buy 59,354 01/21/2020 Buy 257,889 02/18/2019 Buy 59,354 05/08/2019 Buy 257,889 11/05/2018 Buy 53,132 11/11/2018 Buy 314,360 04/16/2018 Buy 56,796 09/13/2018 Buy 375,355 04/27/2017 Buy 48,280 09/25/2017 Buy 172,979

(W) Yuhan (W) Celltrion

80,000 400,000

60,000 300,000

40,000 200,000

20,000 100,000

0 0 Apr 18 Apr 19Apr Apr 18 20 Apr 19 Apr 20

Stock Ratings Industry Ratings Buy : Relative performance of 20% or greater Overweight : Fundamentals are favorable or improving Trading Buy : Relative performance of 10% or greater, but with volatility Neutral : Fundamentals are steady without any material changes Hold : Relative performance of -10% and 10% Underweight : Fundamentals are unfavorable or worsening Sell : Relative performance of -10%

Ratings and Target Price History (Share price (─), Target price (▬), Not covered (■), Buy (▲), Trading Buy (■), Hold (●), Sell (◆)) * Our investment rating is a guide to the relative return of the stock versus the market over the next 12 months. * Although it is not part of the official ratings at Mirae Asset Daewoo Co., Ltd., we may call a trading opportunity in case there is a technical or short-term material development. * The target price was determined by the research analyst through valuation methods discussed in this report, in part based on the analyst’s estimate of future earnings. * The achievement of the target price may be impeded by risks related to the subject securities and companies, as well as general market and economic conditions.

Equity Ratings Distribution & Investment Banking Services Buy Trading Buy Hold Sell Equity Ratings Distribution 82.04% 12.57% 5.39% 0.00% Investment Banking Services 80.77% 11.54% 7.69% 0.00% * Based on recommendations in the last 12-months (as of March 31, 2020)

14| Biotech/Healthcare Mirae Asset Daewoo Research APPENDIX 1

Disclosures As of the publication date, Mirae Asset Daewoo Co., Ltd. has acted as a liquidity provider for equity-linked warrants backed by shares of Celltrion as an underlying asset; other than this, Mirae Asset Daewoo has no other special interests in the covered companies.

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15| Biotech/Healthcare Mirae Asset Daewoo Research APPENDIX 1

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16| Biotech/Healthcare Mirae Asset Daewoo Research Mirae Asset Daewoo International Network

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17| Biotech/Healthcare Mirae Asset Daewoo Research