HK/China Healthcare Analyst (ex-Fosun Pharma)

Xinyao (Criss) Wang

Equity Capital Markets

Beijing Mabworks Biotech / Equity Capital Markets

On July 18, 2021, <a href="https://www.smartkarma.com/entities/beijing-mabworks-biotech-company-limited" target="_blank" data-smartkarma-citation="entities:33816:1" rel="noopener">Beijing Mabworks Biotech (MWB HK) </a>formally submitted its application to the HKEX for listing on the main board. It should be noted that Mabworks's application for listing on the SSE STAR Market was accepted in September last year, but the Company voluntarily withdrew its application in March this year. Mabworks is a clinical-stage biopharmaceutical company in China focusing on the discovery and development of differentiated antibody drugs. This insight mainly analyzed the clinical-stage drug candidates and related concerns of the Company.

On July 18, 2021, Beijing Mabworks Biotech (MWB HK) formally submitted its application to the HKEX for listing on the main board. It should be noted that Mabworks's application for listing on the SSE STAR Market was accepted in September last year, but the Company voluntarily withdrew its application in March this year. Mabworks is a clinical-stage biopharmaceutical company in China focusing on the discovery and development of differentiated antibody drugs. This insight mainly analyzed the clinical-stage drug candidates and related concerns of the Company.

Pre-IPO Beijing Mabworks Biotech - MIL62 Alone Cannot Save the Situation

Equity Bottom-Up

In August, 2021, after <a href="https://www.smartkarma.com/entities/remegen-co-ltd" target="_blank" data-smartkarma-citation="entities:29191:1" rel="noopener">Remegen Co Ltd (9995 HK)</a> announced that the Company and Seagen Inc. had entered into an exclusive worldwide licensing agreement to develop and commercialize disitamab vedotin (RC48), the share price of RemeGen rose to HK$145.50/share, its second-highest ever. Meanwhile, in June, RemeGen submitted a prospectus to the SSE STAR Market, which was its second IPO application after its listing on the HKEX in November 2020. In September, RemeGen completed its reply to the first round enquiry by Shanghai Stock Exchange. Although RemeGen always seems to inadvertently bring "stimulation" to the market, from this enquiry and the business analysis, we could still find some concerns that worth investors’ attention.

In August, 2021, after Remegen Co Ltd (9995 HK) announced that the Company and Seagen Inc. had entered into an exclusive worldwide licensing agreement to develop and commercialize disitamab vedotin (RC48), the share price of RemeGen rose to HK$145.50/share, its second-highest ever. Meanwhile, in June, RemeGen submitted a prospectus to the SSE STAR Market, which was its second IPO application after its listing on the HKEX in November 2020. In September, RemeGen completed its reply to the first round enquiry by Shanghai Stock Exchange. Although RemeGen always seems to inadvertently bring "stimulation" to the market, from this enquiry and the business analysis, we could still find some concerns that worth investors’ attention. 

Remegen Co Ltd (9995.HK) - Insights About the First Round Enquiry by Shanghai Stock Exchange

On June 9, 2021, China National Medical Products Administration (NMPA) announced that it had conditionally approved the listing of <a href="https://www.smartkarma.com/entities/remegen-co-ltd" target="_blank" data-smartkarma-citation="entities:29191:1" rel="noopener">Remegen Co Ltd (9995 HK)</a>'s RC48, which is the first ADC product independently developed by a domestic pharmaceutical company. Meanwhile, in March this year, RemeGen's another core product RC18 also received conditional marketing approval in China for the treatment of SLE. The approval of the two core products not only means that 2021 officially becomes the first year of RemeGen's commercialization, but more importantly, it is a milestone to confirm the feasibility of RemeGen's antibody and fusion protein platform and antibody-drug conjugate (ADC) platform. This article mainly analyzed the outlook of these two drugs, the pipeline and the concerns of RemeGen.

On June 9, 2021, China National Medical Products Administration (NMPA) announced that it had conditionally approved the listing of Remegen Co Ltd (9995 HK)'s RC48, which is the first ADC product independently developed by a domestic pharmaceutical company. Meanwhile, in March this year, RemeGen's another core product RC18 also received conditional marketing approval in China for the treatment of SLE. The approval of the two core products not only means that 2021 officially becomes the first year of RemeGen's commercialization, but more importantly, it is a milestone to confirm the feasibility of RemeGen's antibody and fusion protein platform and antibody-drug conjugate (ADC) platform. This article mainly analyzed the outlook of these two drugs, the pipeline and the concerns of RemeGen.

RemeGen Co Ltd (9995.HK) - Here Are the Strength and Concerns After Commercialization

Recently, according to the official website, <a href="https://www.smartkarma.com/entities/everest-medicines-ltd" target="_blank" data-smartkarma-citation="entities:29224:1" rel="noopener">Everest Medicines (1952 HK)</a> announced that its sacituzumab govitecan-hziy (SG, Trodelvy) was granted Priority Review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). This marks another progress following the Company's announcement that the NMPA accepted its Biologics License Application (BLA) for SG for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The BLA submission of Trodelvy, the core product candidate of Everest Medicines, was substantially earlier than the Company's previous guidance and our expectations, so it is expected that Trodelvy would contribute sales revenue much earlier, and the Company’s commercialization prospect has reshaped.

Recently, according to the official website, Everest Medicines (1952 HK) announced that its sacituzumab govitecan-hziy (SG, Trodelvy) was granted Priority Review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). This marks another progress following the Company's announcement that the NMPA accepted its Biologics License Application (BLA) for SG for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The BLA submission of Trodelvy, the core product candidate of Everest Medicines, was substantially earlier than the Company's previous guidance and our expectations, so it is expected that Trodelvy would contribute sales revenue much earlier, and the Company’s commercialization prospect has reshaped.

Everest Medicines (1952.HK) - The Commercialization Prospect Has Reshaped

On April 28, <a href="https://www.smartkarma.com/entities/lepu-biopharma-co-ltd" target="_blank" data-smartkarma-citation="entities:33231:1" rel="noopener">Lepu Biopharma (LBP HK)</a>, a subsidiary of <a href="https://www.smartkarma.com/entities/lepu-medical-technology-a" target="_blank" data-smartkarma-citation="entities:16654:1" rel="noopener">Lepu Medical Technology A (300003 CH)</a>, submitted its application to the main board of the Hong Kong Stock Exchange for listing. Actually, many companies in the medical device industry are good at capital operation, such as M&amp;A or spin-off and listing, which has been reflected in the leading medical device companies such as <a href="https://www.smartkarma.com/entities/shenzhen-mindray-bio-medic-a" target="_blank" data-smartkarma-citation="entities:28017:1" rel="noopener">Shenzhen Mindray Bio-Medical Electronics (300760 CH)</a> and <a href="https://www.smartkarma.com/entities/microport-scientific-corp" target="_blank" data-smartkarma-citation="entities:4487:1" rel="noopener">Microport Scientific (853 HK)</a>. However, Lepu Medical is the only one that enters the fields of both drugs and preparations, and according to the pipeline, the focus is not only on generic drugs, but also on biological drugs of higher competitive dimension (e.g. Lepu Biopharma is in this field.). It is also worth mentioning that this is the second company of Lepu factions to be listed in Hong Kong. The first one was <a href="https://www.smartkarma.com/entities/pw-medtech-group-ltd" target="_blank" data-smartkarma-citation="entities:9891:1" rel="noopener">Pw Medtech (1358 HK)</a> (Zhang yue’e is Pu Zhongjie’s wife) and the share price has been very weak since its listing. So can Lepu Biopharma have a better performance?

On April 28, Lepu Biopharma (LBP HK), a subsidiary of Lepu Medical Technology A (300003 CH), submitted its application to the main board of the Hong Kong Stock Exchange for listing. Actually, many companies in the medical device industry are good at capital operation, such as M&amp;A or spin-off and listing, which has been reflected in the leading medical device companies such as Shenzhen Mindray Bio-Medical Electronics (300760 CH) and Microport Scientific (853 HK). However, Lepu Medical is the only one that enters the fields of both drugs and preparations, and according to the pipeline, the focus is not only on generic drugs, but also on biological drugs of higher competitive dimension (e.g. Lepu Biopharma is in this field.). It is also worth mentioning that this is the second company of Lepu factions to be listed in Hong Kong. The first one was Pw Medtech (1358 HK) (Zhang yue’e is Pu Zhongjie’s wife) and the share price has been very weak since its listing. So can Lepu Biopharma have a better performance?

Pre-IPO Lepu Biopharma - There Are Still Many Uncertainties

China

TOT Biopharm International Company Limited operates biopharmaceutical company. The Company focuses on development and commercialisation of tumor drugs and therapies. TOT Biopharm International serves clients in China.

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TOT Biopharm International (1875 HK)

Pre-IPO Beijing Mabworks Biotech - MIL62 Alone Cannot Save the Situation

This article mainly analyzed Mabworks Biotech in terms of the important clinical-stage drug candidates (MIL62, MIL93, MBS301, MIL97, MIL95, MIL86,...

Xinyao (Criss) Wang

Remegen Co Ltd (9995.HK) - Insights About the First Round Enquiry by Shanghai Stock Exchange

This article mainly analyzed RemeGen in terms of its reply to Shanghai Stock Exchange’s first round enquiry, the core products, the pipeline, the...

Xinyao (Criss) Wang

RemeGen Co Ltd (9995.HK) - Here Are the Strength and Concerns After Commercialization

This article mainly analyzed RemeGen in terms of its commercialization of the two core products RC48 and RC18, and the concerns on its pipeline.

Xinyao (Criss) Wang

Everest Medicines (1952.HK) - The Commercialization Prospect Has Reshaped

After the BLA submission of Trodelvy, the commercialization prospect of Everest Medicines has reshaped. This article mainly analyzed the business...

Xinyao (Criss) Wang

Pre-IPO Lepu Biopharma - There Are Still Many Uncertainties

This article analyzed Lepu Biopharma in terms of its core product candidates in the pipeline, the challenges, concerns and future outlook for this...

Xinyao (Criss) Wang

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