Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Sichuan Kelun-Biotech announces Phase 3 trial success for ADC-Keytruda combination therapy in first-line lung cancer. ImmuneOnco received Phase 3 trial approval for IMM0306 lenalidomide combination for follicular lymphoma in China.</li>
<li>Otsuka received FDA accelerated approval of Voyxact for immunoglobulin A nephropathy. Eisai has completed FDA submission of Leqembi Iqlik subcutaneous autoinjector as a weekly starting dose for early Alzheimer’s disease.</li>
<li>Alteogen secures $15M milestone payment from Merck as Keytruda subcutaneous formulation gets EU approval. SK Biopharmaceuticals in-licenses second radiopharmaceutical candidate, which has potential to target clear cell renal cell carcinoma.  </li>
</ul>


Sichuan Kelun-Biotech announces Phase 3 trial success for ADC-Keytruda combination therapy in first-line lung cancer. ImmuneOnco received Phase 3 trial approval for IMM0306 lenalidomide combination for follicular lymphoma in China.
Otsuka received FDA accelerated approval of Voyxact for immunoglobulin A nephropathy. Eisai has completed FDA submission of Leqembi Iqlik subcutaneous autoinjector as a weekly starting dose for early Alzheimer’s disease.
Alteogen secures $15M milestone payment from Merck as Keytruda subcutaneous formulation gets EU approval. SK Biopharmaceuticals in-licenses second radiopharmaceutical candidate, which has potential to target clear cell renal cell carcinoma.  


APAC Healthcare Weekly (November 30) – Kelun Bio, ImmuneOnco, Otsuka, Eisai, Alteogen, SK Biopharma

<ul>
<li>3SBio will spin-off and separately list the shares of Mandi, a subsidiary of the company. Celltrion got EC approval for Remsima IV liquid, world’s first liquid formulation of IV infliximab.</li>
<li>Hanmi Pharmaceutical is acquiring all of the issued and outstanding common shares of Aptose Biosciences that are not currently owned or controlled by Hanmi.</li>
<li>Otsuka got CHMP positive opinion for donidalorsen for the prevention of recurrent attacks of HAE. CSL plans to expand U.S. presence over the next five years, with ~$1.5B U.S. capex.</li>
</ul>


3SBio will spin-off and separately list the shares of Mandi, a subsidiary of the company. Celltrion got EC approval for Remsima IV liquid, world’s first liquid formulation of IV infliximab.
Hanmi Pharmaceutical is acquiring all of the issued and outstanding common shares of Aptose Biosciences that are not currently owned or controlled by Hanmi.
Otsuka got CHMP positive opinion for donidalorsen for the prevention of recurrent attacks of HAE. CSL plans to expand U.S. presence over the next five years, with ~$1.5B U.S. capex.


APAC Healthcare Weekly (November 23) – 3SBio, Celltrion, Hanmi Pharm, HK Inno.N, Otsuka, CSL

<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>Takeda has dropped AstraZeneca-partnered antibody drug candidate from its pipeline. Eisai and Merck are closing late-stage trial of Lenvima plus Keytruda in hepatocellular carcinoma on disappointing result.</li>
<li>Wuxi AppTec sharpens CRDMO business by selling its China-based clinical research subsidiaries. FDA has designated Celltrion’s Stoboclo and Osenvelt as interchangeable biosimilars to the reference products Prolia and Xgeva, respectively.</li>
<li>CSL is delaying demerger of CSL Seqirus ‘to maximise shareholder value.’ PharmaEssentia has filed for the additional indication of Besremi for Essential Thrombocythemia (ET) with the FDA.</li>
</ul>


Takeda has dropped AstraZeneca-partnered antibody drug candidate from its pipeline. Eisai and Merck are closing late-stage trial of Lenvima plus Keytruda in hepatocellular carcinoma on disappointing result.
Wuxi AppTec sharpens CRDMO business by selling its China-based clinical research subsidiaries. FDA has designated Celltrion’s Stoboclo and Osenvelt as interchangeable biosimilars to the reference products Prolia and Xgeva, respectively.
CSL is delaying demerger of CSL Seqirus ‘to maximise shareholder value.’ PharmaEssentia has filed for the additional indication of Besremi for Essential Thrombocythemia (ET) with the FDA.


APAC Healthcare Weekly (November 2) – Takeda, Eisai, Wuxi AppTec, Celltrion, CSL, PharmaEssentia

<ul>
<li>Innovent Biologics announced strategic global collaboration with Takeda for total deal value of $11.4B. Akeso announced that phase 3 trial evaluating ivonescimab versus tislelizumab in sq-NSCLC met primary endpoint.</li>
<li>Celltrion received FDA approval for two additional pediatric indications for Humira biosimilar, Yuflyma. Classys plans to acquire 77.5% stake in JL Health, South American energy-based aesthetic medical device distribution group. </li>
<li>Syngene plans to add a bioconjugation suite at its commercial biologics facility. Cipla and Eli Lilly agreed to distribute and promote tirzepatide in India under a second brand name, Yurpeak.</li>
</ul>


Innovent Biologics announced strategic global collaboration with Takeda for total deal value of $11.4B. Akeso announced that phase 3 trial evaluating ivonescimab versus tislelizumab in sq-NSCLC met primary endpoint.
Celltrion received FDA approval for two additional pediatric indications for Humira biosimilar, Yuflyma. Classys plans to acquire 77.5% stake in JL Health, South American energy-based aesthetic medical device distribution group. 
Syngene plans to add a bioconjugation suite at its commercial biologics facility. Cipla and Eli Lilly agreed to distribute and promote tirzepatide in India under a second brand name, Yurpeak.


APAC Healthcare Weekly (October 26) – Innovent, Akeso, Celltrion, Classys, Daiichi, Syngene, Cipla

South Korea

Celltrion, Inc. produces and sells biosimilar products, as well as consignment processing services for other businesses.

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Celltrion (068270 KP)

APAC Healthcare Weekly (November 30) – Kelun Bio, ImmuneOnco, Otsuka, Eisai, Alteogen, SK Biopharma

Kelun Bio announces Phase 3 trial success for ADC-Keytruda combo in first-line lung cancer. Otsuka got FDA approval for IgAN drug. Alteogen secures...

Tina Banerjee

APAC Healthcare Weekly (November 23) – 3SBio, Celltrion, Hanmi Pharm, HK Inno.N, Otsuka, CSL

3SBio will spin-off and separately list its subsidiary. Celltrion got EC approval for Remsima IV liquid. Hanmi Pharm is acquiring Aptose...

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 (November 2) – Takeda, Eisai, Wuxi AppTec, Celltrion, CSL, PharmaEssentia

Takeda and Eisai witnessed clinical trials setback. Wuxi AppTec is selling China-based CRO subsidiaries. CSL is delaying demerger of CSL Seqirus....

Tina Banerjee

APAC Healthcare Weekly (October 26) – Innovent, Akeso, Celltrion, Classys, Daiichi, Syngene, Cipla

Innovent Biologics announced collaboration with Takeda. FDA approves two additional indications for Celltrion's Humira biosimilar. Syngene is...

Tina Banerjee

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