Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Sino Biopharmaceutical entered outlicensing agreement with Sanofi for rovadicitinib for upfront payment of $135M. Antengene entered outlicensing agreement with UCB for ATG-201 for upfront and near-term milestone payment of $80M.</li>
<li>FDA accepted Takeda’s NDA for polycythemia vera drug rusfertide and granted Priority Review.  Sumitomo Pharma received conditional and time‑limited approval in Japan for the allogeneic cell product Amchepry.</li>
<li>FDA has cleared ABL Bio’s application for a Phase 1 clinical trial of ABL209. Glenmark Pharmaceuticals received FDA approval for generic Flovent with 180-day CGT exclusivity.</li>
</ul>


Sino Biopharmaceutical entered outlicensing agreement with Sanofi for rovadicitinib for upfront payment of $135M. Antengene entered outlicensing agreement with UCB for ATG-201 for upfront and near-term milestone payment of $80M.
FDA accepted Takeda’s NDA for polycythemia vera drug rusfertide and granted Priority Review.  Sumitomo Pharma received conditional and time‑limited approval in Japan for the allogeneic cell product Amchepry.
FDA has cleared ABL Bio’s application for a Phase 1 clinical trial of ABL209. Glenmark Pharmaceuticals received FDA approval for generic Flovent with 180-day CGT exclusivity.


APAC Healthcare Weekly (March 8) – Sino Bio, Antengene, Takeda, Sumitomo Pharma, ABL Bio, Glenmark

<ul>
<li>Sino Biopharmaceutical got indication expansion approval for benmelstobart in stage III NSCLC in China. Hansoh Pharmaceutical got EU approval for Ameile as first-line treatment of advanced NSCLC.</li>
<li>EMA validated Daiichi Sankyo’s marketing authorization application for Enhertu as a monotherapy for HER2+ breast cancer. FDA accepted Ono Pharmaceutical’s NDA for primary central nervous system lymphoma drug candidate tirabrutinib.</li>
<li>ABL Bio initiates global phase 2 trial evaluating ABL111 as first-line treatment for metastatic gastric cancer. CSL entered an exclusive outlicensing agreement with Eli Lilly to develop and commercialise clazakizumab.</li>
</ul>


Sino Biopharmaceutical got indication expansion approval for benmelstobart in stage III NSCLC in China. Hansoh Pharmaceutical got EU approval for Ameile as first-line treatment of advanced NSCLC.
EMA validated Daiichi Sankyo’s marketing authorization application for Enhertu as a monotherapy for HER2+ breast cancer. FDA accepted Ono Pharmaceutical’s NDA for primary central nervous system lymphoma drug candidate tirabrutinib.
ABL Bio initiates global phase 2 trial evaluating ABL111 as first-line treatment for metastatic gastric cancer. CSL entered an exclusive outlicensing agreement with Eli Lilly to develop and commercialise clazakizumab.


APAC Healthcare Weekly (February 22) – Sino Bio, Hansoh Pharma, Daiichi Sankyo, Ono, ABL Bio, CSL

<ul>
<li>Shanghai Henlius Biotech entered outlicensing agreement with Eisai for serplulimab for upfront payment of $75M. Wuxi Biologics has signed a license and research service agreement with Vertex Pharmaceuticals. </li>
<li>Daiichi Sankyo’s indication expansion application for Datroway in TNBC has been accepted and granted Priority Review in the U.S. PeptiDream has initiated registrational Phase 2 clinical trial of radiotherapeutic candidate.</li>
<li>ABL Bio submitted clinical trial application to the FDA for a Phase 1 clinical trial of ADC candidate ABL209. SK Bioscience is in-licensing a clinical-stage RSV vaccine candidate.</li>
</ul>


Shanghai Henlius Biotech entered outlicensing agreement with Eisai for serplulimab for upfront payment of $75M. Wuxi Biologics has signed a license and research service agreement with Vertex Pharmaceuticals. 
Daiichi Sankyo’s indication expansion application for Datroway in TNBC has been accepted and granted Priority Review in the U.S. PeptiDream has initiated registrational Phase 2 clinical trial of radiotherapeutic candidate.
ABL Bio submitted clinical trial application to the FDA for a Phase 1 clinical trial of ADC candidate ABL209. SK Bioscience is in-licensing a clinical-stage RSV vaccine candidate.


APAC Healthcare Weekly (February 8) – Henlius Bio, Wuxi Bio, Daiichi Sankyo, Peptidream, ABL Bio

<ul>
<li>Simcere entered outlicensing agreement with Boehringer Ingelheim for IBD drug candidate SIM0709 for upfront payment of €42M. CSPC entered collaboration and license agreement with AstraZeneca for upfront payment of $1.2B.</li>
<li>Hanmi Pharm signs exclusive Mexico distribution deal for GLP-1 obesity drug efpeglenatide. HK inno.N will be launching 'X1 Plus Tablet', a triple antihypertensive drug for the first time in Korea.</li>
<li>Eisai’s Leqembi autoinjector is now under FDA review as weekly starting dose, with target action date of May 24. Chugai Pharmaceutical filed for additional indication of Tecentriq for bladder cancer.</li>
</ul>


Simcere entered outlicensing agreement with Boehringer Ingelheim for IBD drug candidate SIM0709 for upfront payment of €42M. CSPC entered collaboration and license agreement with AstraZeneca for upfront payment of $1.2B.
Hanmi Pharm signs exclusive Mexico distribution deal for GLP-1 obesity drug efpeglenatide. HK inno.N will be launching 'X1 Plus Tablet', a triple antihypertensive drug for the first time in Korea.
Eisai’s Leqembi autoinjector is now under FDA review as weekly starting dose, with target action date of May 24. Chugai Pharmaceutical filed for additional indication of Tecentriq for bladder cancer.


APAC Healthcare Weekly (February 1) – Simcere, CSPC, Hanmi Pharm, HK Inno.N, Eisai, Chugai Pharma

<ul>
<li>Insilico Medicine entered into outlicensing agreement for ISM8969 with Hygtia Therapeutics for upfront and milestone payment of $66M. Daiichi Sankyo’s Enhertu got its sixth indication approval in China.</li>
<li>Shionogi will pick up Pfizer’s 11.7% stake in HIV-focused ViiV Healthcare for $2.1B. Alteogen signed an exclusive license agreement with GSK’s subsidiary Tesaro for ALT-B4 for upfront payment of $20M.</li>
<li>HK inno.N completes enrolment for Phase 3 clinical trial for its once-weekly GLP-1 obesity drug candidate, IN-B00009. Sun Pharmaceutical has received approval for generic version of semaglutide injection in India.</li>
</ul>


Insilico Medicine entered into outlicensing agreement for ISM8969 with Hygtia Therapeutics for upfront and milestone payment of $66M. Daiichi Sankyo’s Enhertu got its sixth indication approval in China.
Shionogi will pick up Pfizer’s 11.7% stake in HIV-focused ViiV Healthcare for $2.1B. Alteogen signed an exclusive license agreement with GSK’s subsidiary Tesaro for ALT-B4 for upfront payment of $20M.
HK inno.N completes enrolment for Phase 3 clinical trial for its once-weekly GLP-1 obesity drug candidate, IN-B00009. Sun Pharmaceutical has received approval for generic version of semaglutide injection in India.


APAC Healthcare Weekly (January 25) – InSilico, Daiichi, Shionogi, Alteogen, HK Inno, Sun Pharma

China

Shanghai Henlius Biotech is a global, innovation-driven biopharmaceutical company focused on delivering high-quality, affordable biologic therapies for oncology, autoimmune diseases, and ophthalmic diseases. The company is engaged in biopharmaceutical research and development, manufacturing, and commercialization, offering products such as the biosimilars HANLIKANG (rituximab), HANQUYOU (trastuzumab), HANDAYUAN (adalimumab), and HANBEITAI (bevacizumab), as well as the innovative biologic HANSIZHUANG (serplulimab). Headquartered in Shanghai, China, the company was founded in 2010.

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Shanghai Henlius Biotech (2696 HK)

APAC Healthcare Weekly (March 8) – Sino Bio, Antengene, Takeda, Sumitomo Pharma, ABL Bio, Glenmark

Sino Bio and Anetengene stuck outlicensing deals with Sanofi and UCB, respectively. FDA accepted Takeda’s NDA for rusfertide. Sumitomo Pharma got...

Tina Banerjee

APAC Healthcare Weekly (February 22) – Sino Bio, Hansoh Pharma, Daiichi Sankyo, Ono, ABL Bio, CSL

Hansoh Pharma got EU approval for Ameile. EMA validated Daiichi Sankyo’s Enhertu in breast cancer. FDA accepted Ono Pharmaceutical’s tirabrutinib....

Tina Banerjee

APAC Healthcare Weekly (February 8) – Henlius Bio, Wuxi Bio, Daiichi Sankyo, Peptidream, ABL Bio

Henlius stuck outlicensing deal with Eisai. Wuxi Bio signs deal with Vertex. Daiichi’s Datroway got priority review in U.S. for TNBC. PeptiDream...

Tina Banerjee

APAC Healthcare Weekly (February 1) – Simcere, CSPC, Hanmi Pharm, HK Inno.N, Eisai, Chugai Pharma

CSPC and Simcere signed outlicensing deals with AstraZeneca and Boehringer Ingelheim, respectively. Eisai’s Leqembi autoinjector is now under FDA...

Tina Banerjee

APAC Healthcare Weekly (January 25) – InSilico, Daiichi, Shionogi, Alteogen, HK Inno, Sun Pharma

InSilico entered outlicensing deal. Daiichi’s Enhertu got China approval for 6th indication. Shionogi will pick up Pfizer’s stake in ViiV...

Tina Banerjee

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