Created in China, the first bispecific antibody evaluation report is coming!

According to the data of the drug financing cloud, www.
pharnexcloud.
com shows that Candonilimab injection (R&D code: AK104) was approved by the National Medical Products Administration (NMPA) of China in June 2022 for the treatment of recurrent or metastatic cervical cancer (R/M CC) that has failed previous platinum-containing chemotherapy patient, became the world's first approved PD-1/CTLA-4 bispecific antibody
.

▲Pharma Cloud Data: www.
pharnexcloud.
com;

This product patent WO-2017071625

Cervical cancer ranks fourth in the world for female malignant tumors, and the treatment of advanced and recurrent cervical cancer is limited, with a 5-year survival rate of less than 20%.

Squamous cell carcinoma is the most common among cervical cancers, accounting for about 70%, followed by adenocarcinoma at 25%.

Persistent infection with human papilloma virus (HPV) causes almost 6 cervical cancers
.
In view of the unmet clinical needs, the efficacy, safety, efficacy prediction markers and treatment regimens of immunotherapy are also becoming the focus of attention in the
field of gynecology.
Accelerated approval of pembrolizumab in June 2018 for the treatment of patients with advanced cervical cancer (CPS≥ 1) during or after chemotherapy, and full approval for this indication in October 2021, along with the approval of pembrolizumab in combination with chemotherapy ±in patients with persistent, relapsed, or metastatic cervical cancer (CPS≥ 1
).
。 In September 2021, TIVDAK TM (tisotumab vedotintftv), an ADC drug targeting tissue factors, was approved in the US for the treatment of patients with relapsed or metastatic cervical cancer whose disease progresses during or after chemotherapy
.

The number of patients with recurrent or metastatic cervical cancer in China is large, and there is a significant unmet clinical need, and the use of immune checkpoint inhibitors of PD-1 for the treatment of cervical squamous cell carcinoma and adenocarcinoma has the potential
to benefit.
The approval is based on a pivotal clinical study of patients with relapsed or metastatic cervical cancer (R/M CC) who have failed previous platinum-containing chemotherapy
.
The results of the study were presented
at the 2022 American Society of Gynecologic Oncology (SGO) Annual Meeting.

• Among the 100 assessable whole-population patients (whether PD-L1 expression positive or negative), the objective response rate (ORR) confirmed by the Independent Imaging Evaluation Committee (IRRC) was 33.
  0%, with a complete response (CR) rate of 12.
  0%, a 6- and 12-month sustained response time (DOR) rate of 77.
  6% and 52.
  9%, a median progression-free survival (mPFS) of 3.
  75 months, and a median survival (mOS) of 17.
  51 months
  。
• In PD-L1 positive (CPS≥1) patients, ORR was as high as 43.
  8%, mPFS was as high as 6.
  34 months, and mOS data were not mature
  .
  
• The incidence of grade ≥3 treatment-related adverse events (TRAEs) was 27.
  0%
  in all enrolled patients.
  

▲ Product name: Kaitanil generic name: Cardonilimab injection specification: 125mg (10ml) / bottle

Indications: For the treatment of patients with relapsed or metastatic cervical cancer (R/M CC) who have failed previous platinum-containing chemotherapy

Yaorong cloud data, display price: 13220.
00 yuan / piece; The patient assistance program is specifically adopted as follows: adopt the "3+2" model

Cardunilimab adopts IgG-ScFv structure, which can quickly mediate independent PD-1 or CTLA-4 endocytosis on the basis of ensuring good antigen-differentiated binding with high retention of tumor tissue; In addition, the IgG1 backbone of kadunilimab shows more stable structural features and introduces Fc segment point mutations, eliminating the effect function of the Fc segment and bringing it a better safety profile
.
Previous clinical studies have shown that cardunilib is significantly superior to marketed CTLA-4 inhibitors in terms of overall safety and comparable
to marketed PD-1/PD-L1 inhibitors.
The near-term planned clinical development plans are as follows:

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