LAEKNA-B (02105.HK): First subject enrolled in Phase I clinical study of LAE118 for advanced solid tumours

NewTimeSpace News: On 1 September 2026, LAEKNA-B (02105.HK) announced that the first subject has been enrolled in the Phase I clinical study of LAE118, a novel PI3Kα pan-mutation selective inhibitor, for advanced solid tumours in China; the drug has received IND approval from the US FDA and CDE, and in June 2026 the Group entered into an exclusive licence agreement with Vasque Bio providing for payments of up to USD 527 million.

NewTimeSpace News: On 1 September 2026, Laekna, Inc. (stock code: 02105) announced that the Group has initiated subject recruitment for the Phase I clinical study of LAE118 for the treatment of advanced solid tumours in China, with the first subject enrolled. LAE118 is a novel PI3Kα pan-mutation selective inhibitor independently developed by the Group, which has obtained investigational new drug (IND) approval from the US FDA and the Centre for Drug Evaluation (CDE) of China's National Medical Products Administration as of the date of this announcement.

In June 2026, the Group entered into an exclusive licence agreement with Vasque Bio, Inc. Under the agreement, the Group is entitled to receive upfront and milestone payments of up to USD 527 million in aggregate, which are non-refundable and non-creditable, as well as tiered sales royalties of single-digit to double-digit percentages of the future net sales of LAE118 in the licensed territory. The Group is also entitled, without additional consideration, to equity interests of up to high double-digit percentages of the issued ordinary shares of Vasque Bio, or cash payments in lieu of such ordinary shares. If Vasque Bio completes an eligible strategic cooperation or acquisition transaction meeting certain conditions related to the use of LAE118, the Group will be entitled to additional payments of up to 50% of the value of such strategic transaction.

Vasque Bio is a US-based clinical-stage biotechnology company focused on developing innovative therapies for serious rare diseases, supported by a consortium of leading life science investors including The Column Group (TCG) and F-Prime, while the Group focuses on developing LAE118 as an oncology therapy outside the licensed territory. The Company noted that LAE118 may ultimately not be successfully developed and commercialised.

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