Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Hansoh’s fourth-generation EGFR TKI HS-10504 tablets secured Breakthrough Therapy Designation in China for NSCLC. Junshi Biosciences got 13th indication expansion approval for toripalimab for HER2-expressing locally advanced or metastatic UC.</li>
<li>Daiichi Sankyo secured FDA approval for Enhertu’s two new breast cancer indications. The company’s Datroway got U.S. approval for TNBC. Japan approved NHI price for SanBio’s Akuugo.</li>
<li>Hanmi Pharmaceutical initiated domestic Phase 3 trial to expand indication for efpeglenatide beyond obesity to include the treatment of diabetes. Yuhan Corp signed $140M API supply contract with Gilead Sciences.</li>
</ul>


Hansoh’s fourth-generation EGFR TKI HS-10504 tablets secured Breakthrough Therapy Designation in China for NSCLC. Junshi Biosciences got 13th indication expansion approval for toripalimab for HER2-expressing locally advanced or metastatic UC.
Daiichi Sankyo secured FDA approval for Enhertu’s two new breast cancer indications. The company’s Datroway got U.S. approval for TNBC. Japan approved NHI price for SanBio’s Akuugo.
Hanmi Pharmaceutical initiated domestic Phase 3 trial to expand indication for efpeglenatide beyond obesity to include the treatment of diabetes. Yuhan Corp signed $140M API supply contract with Gilead Sciences.


APAC Healthcare Weekly (May 24)– Hansoh, Junshi Bio, Daiichi Sankyo, SanBio, Hanmi Pharm, Yuhan Corp

<ul>
<li>Shanghai Henlius Biotech announced that PMDA of Japan approved phase 2/3 clinical trial of HLX43 for injection (an anti-PD-L1 antibody-drug conjugate) for advanced squamous non-small cell lung cancer (NSCLC).</li>
<li>Simcere Pharmaceutical announced that, SIM0613 for Injection, an antibody-drug conjugate, received the clinical trial approval in China, and is intended for commencing the clinical trial for advanced solid tumors.</li>
<li>Olympus has signed an exclusive global distribution agreement with EndoRobotics. Under this agreement, robot-assisted technologies manufactured by EndoRobotics will be distributed globally by Olympus exclusively.</li>
</ul>


Shanghai Henlius Biotech announced that PMDA of Japan approved phase 2/3 clinical trial of HLX43 for injection (an anti-PD-L1 antibody-drug conjugate) for advanced squamous non-small cell lung cancer (NSCLC).
Simcere Pharmaceutical announced that, SIM0613 for Injection, an antibody-drug conjugate, received the clinical trial approval in China, and is intended for commencing the clinical trial for advanced solid tumors.
Olympus has signed an exclusive global distribution agreement with EndoRobotics. Under this agreement, robot-assisted technologies manufactured by EndoRobotics will be distributed globally by Olympus exclusively.


APAC Healthcare Weekly (May 10) – Henlius Bio, Simcere, Olympus, Daewoong Pharma

<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>Celltrion inlicensed two antibody-based new drug candidates for the treatment of autoimmune diseases in KRW1T deal. Dong-A ST received approval for epilepsy drug, Xcopri, developed by SK Biopharmaceuticals in Korea.</li>
<li>Hanmi Pharmaceutical will distribute and sell three major COPD treatments developed by Boehringer Ingelheim. Shandong Boan Biotechnology’s marketing application for denosumab biosimilar has been accepted in the UK.  </li>
<li>Eisai has settled patent infringement litigation with Torrent Pharmaceuticals related to Lenvima in the U.S. Otsuka Holdings initiated Phase 3 clinical trial evaluating quabodepistat, for the treatment of multidrug-resistant tuberculosis.</li>
</ul>


Celltrion inlicensed two antibody-based new drug candidates for the treatment of autoimmune diseases in KRW1T deal. Dong-A ST received approval for epilepsy drug, Xcopri, developed by SK Biopharmaceuticals in Korea.
Hanmi Pharmaceutical will distribute and sell three major COPD treatments developed by Boehringer Ingelheim. Shandong Boan Biotechnology’s marketing application for denosumab biosimilar has been accepted in the UK.  
Eisai has settled patent infringement litigation with Torrent Pharmaceuticals related to Lenvima in the U.S. Otsuka Holdings initiated Phase 3 clinical trial evaluating quabodepistat, for the treatment of multidrug-resistant tuberculosis.


APAC Healthcare Weekly (November 9) – Celltrion, Dong-A ST, Hanmi Pharm, Boan Bio, Eisai, Otsuka

<ul>
<li>Fosun Pharmaceutical’s marketing application of acute lymphoblastic leukemia drug was accepted by the NMPA. CSPC Pharma obtained approval to conduct clinical trial for Leqembi biosimilar in China.</li>
<li>Celltrion is acquiring Eli Lilly’s New Jersey biopharmaceutical production plant for KRW460B. Lotus Pharmaceutical is acquiring Alvogen US, a privately held, fully integrated pharmaceutical company.</li>
<li>Glenmark Pharmaceutical entered into an exclusive license and collaboration agreement with Hengrui Pharma for Trastuzumab Rezetecan, a next-generation HER2-targeting antibody drug conjugate (ADC) for an upfront payment of $18M.</li>
</ul>


Fosun Pharmaceutical’s marketing application of acute lymphoblastic leukemia drug was accepted by the NMPA. CSPC Pharma obtained approval to conduct clinical trial for Leqembi biosimilar in China.
Celltrion is acquiring Eli Lilly’s New Jersey biopharmaceutical production plant for KRW460B. Lotus Pharmaceutical is acquiring Alvogen US, a privately held, fully integrated pharmaceutical company.
Glenmark Pharmaceutical entered into an exclusive license and collaboration agreement with Hengrui Pharma for Trastuzumab Rezetecan, a next-generation HER2-targeting antibody drug conjugate (ADC) for an upfront payment of $18M.


APAC Healthcare Weekly (September 28) – Fosun Pharma, CSPC Pharma, Celltrion, Lotus Pharma, Glenmark

Taiwan

Lotus Pharmaceutical Co., Ltd. manufactures and distributes oral medicine, ointment and injection medicine.

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Lotus Pharmaceutical (1795 TT)

APAC Healthcare Weekly (May 24)– Hansoh, Junshi Bio, Daiichi Sankyo, SanBio, Hanmi Pharm, Yuhan Corp

Hansoh’s HS-10504 tablets secured BTD in China. Junshi Bio secured 13th indication approval for toripalimab. Daiichi Sanyo’s Enhertu and Datroway...

Tina Banerjee

APAC Healthcare Weekly (May 10) – Henlius Bio, Simcere, Olympus, Daewoong Pharma

Henlius Bio and Simcere got trial approval for their respective ADC candidates in Japan and China, respectively. Olympus forges exclusive global...

Tina Banerjee

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 (November 9) – Celltrion, Dong-A ST, Hanmi Pharm, Boan Bio, Eisai, Otsuka

Celltrion inlicensed two antibody drug candidates in KRW1T deal. Dong-A got domestic approval for Xcopri. Hanmi Pharm will distribute Boehringer...

Tina Banerjee

APAC Healthcare Weekly (September 28) – Fosun Pharma, CSPC Pharma, Celltrion, Lotus Pharma, Glenmark

CSPC Pharma got trial approval for Leqembi biosimilar. Celltrion is acquiring Lilly’s plant. Lotus Pharmaceutical is acquiring Alvogen US. Hengrui...

Tina Banerjee

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