Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Hengrui outlicenses once-weekly oral obesity drug candidate HRS-1596, to Novo for total deal value of $2.6B. EC revoked the EU marketing authorization for Hansoh’s lung cancer drug aumolertinib.</li>
<li>Roche halts development of obesity drug candidate emugrobart and returns all rights to Chugai. Daiichi Sankyo has withdrawn the BLA seeking accelerated approval in the U.S. for I-DXd for ES-SCLC.</li>
<li>Otsuka initiates NDA submission to the FDA for zipalertinib for the treatment of NSCLC. Sun Pharma inlicenses hypercholesterolaemia and dyslipidaemia drug lerodalcibep from LIB Therapeutics.</li>
</ul>


Hengrui outlicenses once-weekly oral obesity drug candidate HRS-1596, to Novo for total deal value of $2.6B. EC revoked the EU marketing authorization for Hansoh’s lung cancer drug aumolertinib.
Roche halts development of obesity drug candidate emugrobart and returns all rights to Chugai. Daiichi Sankyo has withdrawn the BLA seeking accelerated approval in the U.S. for I-DXd for ES-SCLC.
Otsuka initiates NDA submission to the FDA for zipalertinib for the treatment of NSCLC. Sun Pharma inlicenses hypercholesterolaemia and dyslipidaemia drug lerodalcibep from LIB Therapeutics.


APAC Healthcare Weekly (Oct 4) – Hengrui, Hansoh, Chugai Pharma, Daiichi Sankyo, Otsuka, Sun Pharma

<ul>
<li>Hansoh’s risvutatug rezetecan for second-line treatment of SCLC has been included in NMPA’s Priority Review. InSilico completed first patient enrollment and dosing in Phase 3 trial evaluating rentosertib in IPF.</li>
<li>Shionogi received approval in Australia for cefiderocol for the treatment of carbapenem-resistant Gram-negative bacterial infections. Kyowa Kirin’s Phase 2 trial for ophthalmic drug candidate did not meet primary endpoint.</li>
<li>Samsung Biologics signed a new CMO contract worth $262M with a European pharmaceutical company. SK Biopharmaceutical received notification regarding FDA's partial clinical hold on its epilepsy drug candidate, opakalim.</li>
</ul>


Hansoh’s risvutatug rezetecan for second-line treatment of SCLC has been included in NMPA’s Priority Review. InSilico completed first patient enrollment and dosing in Phase 3 trial evaluating rentosertib in IPF.
Shionogi received approval in Australia for cefiderocol for the treatment of carbapenem-resistant Gram-negative bacterial infections. Kyowa Kirin’s Phase 2 trial for ophthalmic drug candidate did not meet primary endpoint.
Samsung Biologics signed a new CMO contract worth $262M with a European pharmaceutical company. SK Biopharmaceutical received notification regarding FDA's partial clinical hold on its epilepsy drug candidate, opakalim.


APAC Healthcare Weekly (Sept 13) – Hansoh, InSilico, Shionogi, Kyowa Kirin, Samsung Bio, SK Biopharm

<ul>
<li>CSPC Pharmaceutical’s SYS6010 met primary endpoint in Phase 3 study as a monotherapy for NSCLC. Akeso’s ivonescimab demonstrates significant overall survival in Phase 3 trial for advanced biliary tract cancer.</li>
<li>Takeda Pharma secured FDA approval for Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera. Astellas Pharma initiates global Phase 3 study evaluating ASP2138 for gastric cancers.</li>
<li>Hanmi Pharm outlicenses obesity drug candidate HM1732 to Genentech for a total deal value of $2.3B. SK Biopharmaceuticals entered an agreement to in-license opakalim, an investigational antiseizure medication, from Biohaven.</li>
</ul>


CSPC Pharmaceutical’s SYS6010 met primary endpoint in Phase 3 study as a monotherapy for NSCLC. Akeso’s ivonescimab demonstrates significant overall survival in Phase 3 trial for advanced biliary tract cancer.
Takeda Pharma secured FDA approval for Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera. Astellas Pharma initiates global Phase 3 study evaluating ASP2138 for gastric cancers.
Hanmi Pharm outlicenses obesity drug candidate HM1732 to Genentech for a total deal value of $2.3B. SK Biopharmaceuticals entered an agreement to in-license opakalim, an investigational antiseizure medication, from Biohaven.


APAC Healthcare Weekly (August 30)– CSPC Pharma, Akeso, Takeda, Astellas, Hanmi Pharm, SK Biopharma

Equity Capital Markets

<ul>
<li>
<a href="https://www.smartkarma.com/entities/ascletis-pharma-inc" target="_blank" data-smartkarma-citation="entities:27265:1" rel="noopener">Ascletis Pharma Inc (1672 HK)</a> is placing ~69M shares at the price of HK$12.18 per share. The placing shares represent ~7% of the total issued shares of the company.</li>
<li>The company intends to use net proceeds for preparation, groundwork and launch of global Phase 3 trials of small molecule oral GLP-1 receptor agonist ASC30 for the treatment of obesity.</li>
<li>Although Ascletis has some near-term catalysts (trial data readout), we do not expect the spectacular rally in the share price over the last one year to be replicated again.</li>
</ul>



Ascletis Pharma Inc (1672 HK) is placing ~69M shares at the price of HK$12.18 per share. The placing shares represent ~7% of the total issued shares of the company.
The company intends to use net proceeds for preparation, groundwork and launch of global Phase 3 trials of small molecule oral GLP-1 receptor agonist ASC30 for the treatment of obesity.
Although Ascletis has some near-term catalysts (trial data readout), we do not expect the spectacular rally in the share price over the last one year to be replicated again.


Ascletis Pharma (1672 HK): Pipeline Not Appealing Enough to Make the Placement Attractive

<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

China

Ascletis Pharma is a fully integrated biotechnology company focused on the research, development, production, marketing, and sale of innovative pharmaceutical products. The company's marketed products include Ritonavir tablets, GANOVO®, and ASCLEVIR® for Hepatitis C, and it has a robust pipeline primarily in metabolic diseases, viral diseases, and oncology. Ascletis Pharma is headquartered in Hangzhou, China, and was founded in 2011.

Price Gauge
52-week Range	0.00 - 0.00
Market Cap (USDm)	0.00
P/E	0.00
Dividend (Yield)	0.00

Ascletis Pharma (1672 HK)

APAC Healthcare Weekly (Oct 4) – Hengrui, Hansoh, Chugai Pharma, Daiichi Sankyo, Otsuka, Sun Pharma

Hengrui stuck $2.6B outlicensing deal with Novo. EC revoked EU marketing authorization of Hansoh’s aumolertinib. Otsuka initiates NDA submission to...

Tina Banerjee

APAC Healthcare Weekly (Sept 13) – Hansoh, InSilico, Shionogi, Kyowa Kirin, Samsung Bio, SK Biopharm

Hansoh’s risvutatug rezetecan has been included in NMPA’s Priority Review. InSilico initiates rentosertib Phase 3 trial in IPF. Samsung Biologics...

Tina Banerjee

APAC Healthcare Weekly (August 30)– CSPC Pharma, Akeso, Takeda, Astellas, Hanmi Pharm, SK Biopharma

CSPC and Akeso announced positive results from their respective Phase 3 trials for cancer drug candidates. Takeda got FDA approval for blood cancer...

Tina Banerjee