HK/China Healthcare Analyst (ex-Fosun Pharma)

Xinyao (Criss) Wang

Equity Bottom-Up

Shenyang Xingqi Pharmaceutical / Equity Bottom-Up

Shenyang Xingqi Pharmaceutical (300573 CH)

<ul>
<li>A document titled "<em>Soliciting Opinions on the Implementation Plan for Supporting the Development of Innovative Drugs throughout the Whole Chain</em>" would completely change the outlook/investment logic of China's innovative drugs.</li>
<li>We predict that due to the early opening of TCM formula granules VBP in some provinces and intensifying competition, the market pattern of TCM formula granules would face reshaping.</li>
<li>After the atropine eye drops is approved by the NMPA, Xingqi’s performance growth will accelerate. Supported by favorable policies, its market value is expected to reach above RMB30 billion.</li>
</ul>


A document titled "Soliciting Opinions on the Implementation Plan for Supporting the Development of Innovative Drugs throughout the Whole Chain" would completely change the outlook/investment logic of China's innovative drugs.
We predict that due to the early opening of TCM formula granules VBP in some provinces and intensifying competition, the market pattern of TCM formula granules would face reshaping.
After the atropine eye drops is approved by the NMPA, Xingqi’s performance growth will accelerate. Supported by favorable policies, its market value is expected to reach above RMB30 billion.


China Healthcare Weekly (Mar.15)- New Policy of Innovative Drug, TCM Formula Granules, Xingqi Pharma

Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Simcere inks outlicensing agreement with Roche for tri-specific antibody in total deal value of $2B+. Hutchmed enters outlicense agreement with GSK for first-in-class drug candidate for upfront payment of $110M.</li>
<li>Akeso’s ivonescimab demonstrates significant overall survival benefit in Keytruda head-to-head trial in NSCLC. Daiichi Sankyo’s Enhertu has been approved in EU for the first-line treatment of HER2 positive breast cancer.</li>
<li>Alteogen inked agreement with Novartis for the development and commercialization of subcutaneous products utilizing ALT-B4. Pharmaessentia secured FDA approval of Besremi for the treatment of essential thrombocythemia.</li>
</ul>


Simcere inks outlicensing agreement with Roche for tri-specific antibody in total deal value of $2B+. Hutchmed enters outlicense agreement with GSK for first-in-class drug candidate for upfront payment of $110M.
Akeso’s ivonescimab demonstrates significant overall survival benefit in Keytruda head-to-head trial in NSCLC. Daiichi Sankyo’s Enhertu has been approved in EU for the first-line treatment of HER2 positive breast cancer.
Alteogen inked agreement with Novartis for the development and commercialization of subcutaneous products utilizing ALT-B4. Pharmaessentia secured FDA approval of Besremi for the treatment of essential thrombocythemia.


APAC Healthcare Weekly (Sept 6) – Simcere, Hutchmed, Akeso, Daiichi Sankyo, Alteogen, Pharmaessentia

<ul>
<li>Fosun Pharmaceutical initiated Phase 2 trial of FXS7553 for COPD in China. CSPC Pharma’s mpox mRNA vaccine candidate obtained clinical trial approval from the FDA.</li>
<li>Akeso secured NMPA approval for ivonescimab, in combination with chemotherapy, for the treatment of first-line squamous non-small cell lung cancer (sq-NSCLC). This indication marks ivonescimab’s third major approval.</li>
<li>Daiichi Sankyo’s Enhertu got China approval for the first-line treatment of breast cancer. Peptidream marked a milestone following the initiation of Phase 1 study for two radioligand therapies by Novartis.</li>
</ul>


Fosun Pharmaceutical initiated Phase 2 trial of FXS7553 for COPD in China. CSPC Pharma’s mpox mRNA vaccine candidate obtained clinical trial approval from the FDA.
Akeso secured NMPA approval for ivonescimab, in combination with chemotherapy, for the treatment of first-line squamous non-small cell lung cancer (sq-NSCLC). This indication marks ivonescimab’s third major approval.
Daiichi Sankyo’s Enhertu got China approval for the first-line treatment of breast cancer. Peptidream marked a milestone following the initiation of Phase 1 study for two radioligand therapies by Novartis.


APAC Healthcare Weekly (August 16) – Akeso, Fosun Pharma, CSPC Pharma, Daiichi Sankyo, Peptidream

<ul>
<li>Jiangsu Hengrui received NMPA approval for camrelizumab as a first-line treatment of recurrent or metastatic cervical cancer. BeOne Medicines announced $300M expansion of its New Jersey manufacturing and R&amp;D center.</li>
<li>Takeda Pharmaceutical got China approval for Orzeyful as a treatment of narcolepsy type 1. Nippon Shinyaku outlicences NS-025 to Aquelys Therapeutics for the treatment of xerostomia associated with Sjögren’s disease.</li>
<li>Samsung Biologics is acquiring PolyPeptide, a leading global CDMO specializing in peptide-based API, for CHF1.46B. Celltrion has applied to the EMA for marketing authorization for its Cosentyx biosimilar candidate, CT-P55. </li>
</ul>


Jiangsu Hengrui received NMPA approval for camrelizumab as a first-line treatment of recurrent or metastatic cervical cancer. BeOne Medicines announced $300M expansion of its New Jersey manufacturing and R&amp;D center.
Takeda Pharmaceutical got China approval for Orzeyful as a treatment of narcolepsy type 1. Nippon Shinyaku outlicences NS-025 to Aquelys Therapeutics for the treatment of xerostomia associated with Sjögren’s disease.
Samsung Biologics is acquiring PolyPeptide, a leading global CDMO specializing in peptide-based API, for CHF1.46B. Celltrion has applied to the EMA for marketing authorization for its Cosentyx biosimilar candidate, CT-P55. 


APAC Healthcare Weekly (July 26) – Hengrui, BeOne, Takeda, Nippon Shinyaku, Samsung Bio, Celltrion

<ul>
<li>Sichuan Kelub Biotech’s sac-TMT in combination with Keytruda as a first-line treatment for PD-L1-negative non-squamous NSCL) met primary endpoint. NMPA accepted CSPC Pharma’s NDA for Trastuzumab Envedotin (HER2-targeted ADC).</li>
<li>InSilico Medicine announced a multi-target strategic alliance with Bora Pharmaceuticals. Eisai secured FDA approval for a once-weekly Leqembi subcutaneous autoinjector as an initiation dose for Alzheimer’s disease.</li>
<li>Celltrion obtained domestic approval for Phase 1 clinical trials for its Tremfya biosimilar candidate, CT-P68. Mesoblast achieved target of 300 patients treated in Phase 3 trial of rexlemestrocel-L for CLBP.</li>
</ul>


Sichuan Kelub Biotech’s sac-TMT in combination with Keytruda as a first-line treatment for PD-L1-negative non-squamous NSCL) met primary endpoint. NMPA accepted CSPC Pharma’s NDA for Trastuzumab Envedotin (HER2-targeted ADC).
InSilico Medicine announced a multi-target strategic alliance with Bora Pharmaceuticals. Eisai secured FDA approval for a once-weekly Leqembi subcutaneous autoinjector as an initiation dose for Alzheimer’s disease.
Celltrion obtained domestic approval for Phase 1 clinical trials for its Tremfya biosimilar candidate, CT-P68. Mesoblast achieved target of 300 patients treated in Phase 3 trial of rexlemestrocel-L for CLBP.


APAC Healthcare Weekly (July 19) – Kelun Bio, CSPC Pharma, Insilico, Eisai, Celltrion, Mesoblast

China

Zhaoke Ophthalmology is an ophthalmic pharmaceutical company focused on the research, development, manufacturing, and commercialization of therapies for unmet medical needs in eye diseases. Its comprehensive drug portfolio addresses conditions such as dry eye disease, myopia, presbyopia, wet age-related macular degeneration, diabetic macular edema, and glaucoma. The company was founded in 2017 and is headquartered in Guangzhou, China.

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Zhaoke Ophthalmology (6622 HK)

China Healthcare Weekly (Mar.15)- New Policy of Innovative Drug, TCM Formula Granules, Xingqi Pharma

New policy of innovative drug is a big deal. We've reasons to start being optimistic.The market pattern of TCM formula granules will face...

Xinyao (Criss) Wang

APAC Healthcare Weekly (Sept 6) – Simcere, Hutchmed, Akeso, Daiichi Sankyo, Alteogen, Pharmaessentia

Simcere and Hutchmend inked outlicensing deals with Roche and GSK, respectively. Akeso’s ivonescimab extends lives vs Keytruda. Alteogen inked...

Tina Banerjee

APAC Healthcare Weekly (August 16) – Akeso, Fosun Pharma, CSPC Pharma, Daiichi Sankyo, Peptidream

Akeso’s ivonescimab and Daiichi Sankyo’s Enhertu got additional indications approvals in China. CSPC Pharma’s mpox mRNA vaccine candidate got FDA...

Tina Banerjee

APAC Healthcare Weekly (July 26) – Hengrui, BeOne, Takeda, Nippon Shinyaku, Samsung Bio, Celltrion

Hengrui’s camrelizumab got indication expansion approval for cervical cancer. BeOne announced $300M expansion plan for US facility. Samsung...

Tina Banerjee

APAC Healthcare Weekly (July 19) – Kelun Bio, CSPC Pharma, Insilico, Eisai, Celltrion, Mesoblast

Kelun Biotech’s sac-TMT met primary endpoint in Phase 3 trial. FDA approves Eisai’s Leqembi Iqlik for Alzheimer’s starting therapy. Mesoblast met...

Tina Banerjee

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