On September 30, 2019 Shanghai Henlius Biotech and PT Kalbe Genexine Biologics (hereinafter referred to "KG Bio"), a holding subsidiary to PT Kalbe Farma, an Indonesian pharmaceutical company, today entered into an Exclusive License Agreement for HLX10 – a recombinant humanized anti-programmed cell death (PD-1) monoclonal antibody (mAb) injection independently developed by Henlius (Press release, Shanghai Henlius Biotech, SEP 30, 2019, View Source [SID1234635133]). With the collaboration, KG Bio will be granted exclusive rights to develop and commercialize HLX10 in relation to (i) the first monotherapy for the treatment of solid tumour (MSI-high) (ii) the two combination therapies and (iii) two new indications KG Bio may in license in accordance with the Agreement in the Asia Pacific territory including the Philippines, Indonesia, Malaysia, Singapore, Thailand, Laos, Myanmar, Cambodia, Brunei and Vietnam. The estimated maximum payment may reach the total value of US$ 692 million including 1) non-creditable payment of US$10 million; 2) commercial sales milestone payments not exceeding US$650 million depending on the level of accumulative net sales of relevant products; 3) regulatory milestone payments not exceeding US$22 million; 4) US$10 million to fund the trials of two combination therapies to be initiated and performed by Henlius.
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Through the collaboration with KG Bio and Kalbe Farma, Henlius will strengthen its market access to Southeast Asia for HLX10 as a part of its international strategy through Kalbe Farma’s extensive sales networking in the market with the aim of sharpening its global competitiveness and brand awareness in the field of immuno-oncology. Moreover, the overall population of Southeast Asia hits 650 million, which translates into significant unmet needs. With the long-term commitment to "affordable innovation", through the collaboration, Henlius will also provide patients in Southeast Asia access to high-quality, affordable and novel biological therapies.
The collaboration also further strengthens the globalization of its immuno-oncology combination therapy in Southeast Asia. Although Anti-PD-1 mAb, as a broad-spectrum immunosuppressant, can be widely applied in the immunotherapy of cancer, it shows low efficacy as mono-therapy. Henlius thus adopts "Combo plus Global" strategy to differentiate its immuno-oncology combination therapy strategy with proprietary mAbs including HLX10 and HLX20 (anti-PD-L1 mAb) as backbones in combination with other therapies and with global multi-center clinical trials ongoing in various countries and regions worldwide.
Looking into the future, Henlius will proactively expand its global presence through continued strategic collaboration with international leading pharmaceutical companies, underscoring its mission to deliver quality products and effective treatment to patients worldwide.