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康方生物(9926.HK):医药增持依沃西新适应症申报上市 管线加速兑现

Kangfang Biology (9926.HK): Increased pharmaceutical holdings and accelerated implementation of the new Evosil application and marketing pipeline

國泰君安 ·  Jul 30

Introduction to this report:

Evosi's first-line PD-L1 expression positive NSCLC indications were declared and marketed, and a number of core indications continued to advance.

Core pipelines such as Cardonelli and Iwasi have successively entered the commercial cashing period, maintaining the “increase in holdings” rating.

Key points of investment:

“Accumulation” rating. The company's core pipeline accelerated implementation, ushered in a harvest period, maintained the 24-26 revenue forecast of 2.896/4.525/6.386 billion yuan, and maintained an “gain” rating.

The pace of harvesting of Iwasi accelerated, and first-line NSCLC declared a listing. On July 29, the company announced that the first-line treatment of ivoracil as a single drug for locally advanced or metastatic NSCLC with positive PD-L1 expression (PD-L1 TPS ≥ 1%) has been accepted by the NMPA and is expected to provide a new “de-chemotherapy” plan for first-line NSCLC. Previously, the phase III clinical results of Evosil monotherapy compared to Pabolizil (K drug) for first-line treatment of PD-L1 positive NSCLC were obtained. The mid-phase analysis reached the main PFS study end. Evosil became the first and only drug in the world to prove that the curative effect was significantly superior to K drug in phase III single-drug head-to-head clinical studies.

Evosi has been newly approved for listing, and many core indications continue to advance. Evosi was approved for marketing by the NMPA in May. The first indication was NSQ-nsCLC, which progressed after treatment with EGFR-TKI in combination with chemotherapy. Follow-up Ivorsi's phase III clinical layout in the field of lung cancer includes:

(1) An international multi-center phase III clinical study of evosilizumab plus chemotherapy versus tirizumab plus chemotherapy for first-line late-stage squamous NSCLC registration is expected to be completed in 2024H2; (2) The international multi-center phase III clinical study of evosil+ chemotherapy for lated/metastatic non-squamous NSCLC progressing through three generations of EGFR-TKI treatment, is expected to complete enrollment in 2024H2; (3) Evosil+chemotherapy led by partner Summit compared with K drug+chemotherapy for first-line metastatic squamous squamous disease NSCLC's phase III clinical trial is in the enrollment phase.

First-line indications for cardonilli have been implemented at an accelerated pace, and rich pipelines have ushered in a harvest period one after another. Cardonil's first-line gastric cancer and first-line cervical cancer indications are currently in the NDA stage, and both indications have obtained positive OS results in phase III clinical trials. Additionally, iroximab (IL-12/23) and inucimab (PCSK9) are in the NDA stage, and ploximab (VEGFR2), gumocimab (IL-17), and mandoximab (IL-4R) are in phase III clinical phase. The company has a deep layout in the ADC field, cooperated with Rongchang Biotech to promote phase II research on gastric cancer with cardonili+verdicitumab (HER2 ADC), and cooperated with Lixin Pharmaceutical to promote research on the use of evasil+LM-302 (Claudin18.2 ADC) for solid tumors; in addition, the company's various self-developed ADCs and dual-antibody ADCs are in the pre-clinical stage.

Risk factors: the risk of uncertainty in the development of new drugs; the risk that commercialization progress falls short of expectations.

The translation is provided by third-party software.


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