Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<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

Healthcare Analyst

Wilfred Yuen

<ul>
<li>
Hutchmed 1H26 showed continued China sales recovery and strong ex-US Fruzaqla growth. CSPC and Antengene announced positive profit alert for 1H26, thanks to their respective deals' upfront payments</li>
<li>
Kelun's TROP2 ADC sac-TMT gained NMPA review for 6th indication 1L TNBC; AstraZeneca's CLDN18.2 ADC (licensed from Keymed/Lepu) hit dual primary endpoint OS in global phase 3 study in GC/GEJ </li>
<li>Other news and updates include Qyuns Therapeutics, Legend Biotech, Innocare
</li>
</ul>



Hutchmed 1H26 showed continued China sales recovery and strong ex-US Fruzaqla growth. CSPC and Antengene announced positive profit alert for 1H26, thanks to their respective deals' upfront payments

Kelun's TROP2 ADC sac-TMT gained NMPA review for 6th indication 1L TNBC; AstraZeneca's CLDN18.2 ADC (licensed from Keymed/Lepu) hit dual primary endpoint OS in global phase 3 study in GC/GEJ 
Other news and updates include Qyuns Therapeutics, Legend Biotech, Innocare



China Healthcare Weekly Wrap (27-31 July)

<ul>
<li>CSPC Pharmaceutical’s Phase 3 trial of depression drug candidate HA1406 met pre-specified primary efficacy endpoint. Jiangsu Hengrui Pharmaceuticals received NMPA approval for long-acting basal insulin, sudelidec injection.</li>
<li>Otsuka Holdings secured FDA approval for Simtriyo, a once-daily extended-release capsule for ADHD. Nippon Shinyaku obtained exclusive commercialization rights for Tadekinig alfa in the U.S. for Hyperinflammatory Syndrome.</li>
<li>Pharmaessentia announced topline results from the Phase 1b clinical trial of P1101 (Besremi) and anti-PD1 in Chronic Hepatitis B or D. Cipla secured FDA approval for generic Advair Diskus.</li>
</ul>


CSPC Pharmaceutical’s Phase 3 trial of depression drug candidate HA1406 met pre-specified primary efficacy endpoint. Jiangsu Hengrui Pharmaceuticals received NMPA approval for long-acting basal insulin, sudelidec injection.
Otsuka Holdings secured FDA approval for Simtriyo, a once-daily extended-release capsule for ADHD. Nippon Shinyaku obtained exclusive commercialization rights for Tadekinig alfa in the U.S. for Hyperinflammatory Syndrome.
Pharmaessentia announced topline results from the Phase 1b clinical trial of P1101 (Besremi) and anti-PD1 in Chronic Hepatitis B or D. Cipla secured FDA approval for generic Advair Diskus.


APAC Healthcare Weekly (August 2) – CSPC, Hengrui, Otsuka, Nippon Shinyaku, PharmaEssnetia, Cipla

<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>Hengrui Pharma received indication expansion approval for trastuzumab rezetecan in China. MicroPort NeuroScientific’s Apollo Dream Rapamycin Target Eluting Stent has been granted the Breakthrough Device Designation by the FDA.</li>
<li>Celltrion signed KRW375B CMO agreement with a global pharmaceutical company for the supply of drug substance. Samsung Bioepis entered global commercialization agreement with Sandoz for five biosimilar candidates under development.</li>
<li>FDA accepted Sun Pharma’s indication expansion application for Ilumya for active psoriatic arthritis. Zydus Lifesciences entered licensing and supply agreements with Torrent Pharmaceuticals and Lupin to co-market Semaglutide in India.</li>
</ul>


Hengrui Pharma received indication expansion approval for trastuzumab rezetecan in China. MicroPort NeuroScientific’s Apollo Dream Rapamycin Target Eluting Stent has been granted the Breakthrough Device Designation by the FDA.
Celltrion signed KRW375B CMO agreement with a global pharmaceutical company for the supply of drug substance. Samsung Bioepis entered global commercialization agreement with Sandoz for five biosimilar candidates under development.
FDA accepted Sun Pharma’s indication expansion application for Ilumya for active psoriatic arthritis. Zydus Lifesciences entered licensing and supply agreements with Torrent Pharmaceuticals and Lupin to co-market Semaglutide in India.


APAC Healthcare Weekly (March 22) – Hengrui, Microport Neuro, Celltrion, Samsung Bio, Sun Pharma

China

Keymed Biosciences is a biotechnology company focused on the in-house discovery and development of innovative biological therapies for autoimmune diseases and oncology. Their pipeline includes over 50 programs, with key products like Kangyueda® (Stapokibart, CM310) for atopic dermatitis, chronic rhinosinusitis with nasal polyps, and seasonal allergic rhinitis. The company was founded in 2016 and is headquartered in Chengdu, China.

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Keymed Biosciences (2162 HK)

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

China Healthcare Weekly Wrap (27-31 July)

Hutchmed 1H26 results takeaways; CSPC and Antengene released positive profit alert; Kelun's sac-TMT gained NMPA review for 1L TNBC; AZ's CLDN18.2...

Wilfred Yuen

APAC Healthcare Weekly (August 2) – CSPC, Hengrui, Otsuka, Nippon Shinyaku, PharmaEssnetia, Cipla

Hengrui got NMPA approval for long-acting insulin. FDA approves Otsuka’s new CNS drug. Pharmaessentia announced positive topline result from Phase...

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 (March 22) – Hengrui, Microport Neuro, Celltrion, Samsung Bio, Sun Pharma

Celltrion signed KRW375B biologics CMO deal with a global pharma company. Samsung Bioepis expands biosimilar collaboration with Sandoz. 40+ Indian...

Tina Banerjee

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