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>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>Eli Lilly announced positive topline results from Phase 3 trial, evaluating orforglipron, discovered by Chugai. Hisamitsu Pharmaceutical initiated Phase 3 trial of HP-6050, a transdermal formulation for sedation in Japan.</li>
<li>WuXi XDC completed GMP release of its new drug product facility in China. CSPC Pharmaceutical’s application for marketing approval of Semaglutide Injection has been accepted by the NMPA of China.</li>
<li>Junshi Biosciences’s indication expansion application for toripalimab for treatment of urothelial carcinoma has been accepted in China. Hanmi Pharma advances HM17321, a first-in-class obesity therapy, into global Phase 1 trials.</li>
</ul>


Eli Lilly announced positive topline results from Phase 3 trial, evaluating orforglipron, discovered by Chugai. Hisamitsu Pharmaceutical initiated Phase 3 trial of HP-6050, a transdermal formulation for sedation in Japan.
WuXi XDC completed GMP release of its new drug product facility in China. CSPC Pharmaceutical’s application for marketing approval of Semaglutide Injection has been accepted by the NMPA of China.
Junshi Biosciences’s indication expansion application for toripalimab for treatment of urothelial carcinoma has been accepted in China. Hanmi Pharma advances HM17321, a first-in-class obesity therapy, into global Phase 1 trials.


APAC Healthcare Weekly (Aug 10) – Chugai, Hisamitsu, Wuxi XDC, CSPC Pharma, Junshi Bio, Hanmi Pharma

<ul>
<li>Shanghai Henlius Biotech initiated Phase 3 U.S. clinical trial for HLX22 for gastroesophageal junction and gastric cancer. CanSino Biologics obtained clinical trial approval in China for polio vaccine.</li>
<li>FDA rejected Nippon Shinyaku’s new drug application for CAP-1002 for DMD. JCR Pharmaceuticals announced license agreement with Acumen Pharmaceuticals to develop Alzheimer’s disease drug using JCR’s BBB -penetrating technology platform.</li>
<li>Mesoblast recorded $13.2M revenue from Ryoncil post-launch March 28 through June 30. Sun Pharma launched Leqselvi in the U.S. for the treatment of adults with severe alopecia areata.</li>
</ul>


Shanghai Henlius Biotech initiated Phase 3 U.S. clinical trial for HLX22 for gastroesophageal junction and gastric cancer. CanSino Biologics obtained clinical trial approval in China for polio vaccine.
FDA rejected Nippon Shinyaku’s new drug application for CAP-1002 for DMD. JCR Pharmaceuticals announced license agreement with Acumen Pharmaceuticals to develop Alzheimer’s disease drug using JCR’s BBB -penetrating technology platform.
Mesoblast recorded $13.2M revenue from Ryoncil post-launch March 28 through June 30. Sun Pharma launched Leqselvi in the U.S. for the treatment of adults with severe alopecia areata.


APAC Healthcare Weekly (July 20) – Henlius Bio, CanSino, Nippon Shinyaku, JCR, Mesoblast, Sun Pharma

<ul>
<li>RemeGen granted exclusive rights to develop and commercialize Telitacicept worldwide (excluding Greater China) to Vor Biopharma for $125M. Innovent Biologics received a first-in-class weight loss drug approval in China.</li>
<li>Daiichi Sankyo received FDA approval for Datroway for the treatment of certain types of non-small cell lung cancer (NSCLC). SanBio now expects Akuugo approval in H2FY26, instead of Q2FY26.</li>
<li>Otsuka in-licensed HBM7020 from Harbour BioMed for an upfront payment of $47M and near-term milestones. Glenmark Pharmaceuticals has launched Beigene’s Tevimbra in India for NSCLC.</li>
</ul>


RemeGen granted exclusive rights to develop and commercialize Telitacicept worldwide (excluding Greater China) to Vor Biopharma for $125M. Innovent Biologics received a first-in-class weight loss drug approval in China.
Daiichi Sankyo received FDA approval for Datroway for the treatment of certain types of non-small cell lung cancer (NSCLC). SanBio now expects Akuugo approval in H2FY26, instead of Q2FY26.
Otsuka in-licensed HBM7020 from Harbour BioMed for an upfront payment of $47M and near-term milestones. Glenmark Pharmaceuticals has launched Beigene’s Tevimbra in India for NSCLC.


APAC Healthcare Weekly (June 29)- RemeGen, Innovent, Daiichi, SanBio, Otsuka, Chugai, Glenmark

Australia

Imugene Limited is a health biotechnology development company.  The Company manufactures vaccines for gastric and breast cancer treatments. Imugene operates in Europe and Australia.

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Imugene Ltd (IMU AU)

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 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 (Aug 10) – Chugai, Hisamitsu, Wuxi XDC, CSPC Pharma, Junshi Bio, Hanmi Pharma

Obesity treatment related development dominated the week, with Chugai’s drug candidate meeting Phase 3 trial goals, CSPC is a step ahead for...

Tina Banerjee

APAC Healthcare Weekly (July 20) – Henlius Bio, CanSino, Nippon Shinyaku, JCR, Mesoblast, Sun Pharma

Henlius Bio initiates P3 U.S. trial for cancer drug. FDA rejected Nippon Shinyaku’s new drug filing. JCR partners with Acumen to develop...

Tina Banerjee

APAC Healthcare Weekly (June 29)- RemeGen, Innovent, Daiichi, SanBio, Otsuka, Chugai, Glenmark

Last week couple of Chinese companies signed outlicensing deals with international players. Innovent got weight loss drug approval in China....

Tina Banerjee

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