On June 29, the latest announcement on the official website of China’s National Medical Products Administration was that the PD-1/CTLA-4 bispecific antibody cardunilimab injection independently developed by Kangfang Biologics was approved for marketing. Patients with recurrent or

2024/05/0402:14:32 science 1853

China's cancer patients have caught up with unprecedented good times! The first domestically developed PD-1/CTLA-4 bispecific antibody Candonilimab injection (Candonilimab, code name AK104) with stronger anti-cancer effect was approved for marketing! This is the first bispecific antibody drug independently developed in China and the first approved PD-1/CTLA-4 immune dual antibody in the world, which is a milestone! With the rise of China's independent research and development of anti-cancer drugs, domestic patients can now receive world-leading new anti-cancer drug treatments!

On June 29, the latest announcement on the official website of China’s National Medical Products Administration was that the PD-1/CTLA-4 bispecific antibody cardunilimab injection independently developed by Kangfang Biologics was approved for marketing. Patients with recurrent or - DayDayNews

Source: Kangfang Bio official website

Immunotherapy is hailed as the hope of conquering cancer and has set off a revolution in tumor treatment. The magic of this therapy is:

1. Restore the body's own immune system to resist and attack cancer. Therefore, the overall side effects are much smaller than traditional chemical drugs;

2. It has a broad-spectrum anti-cancer effect suitable for a variety of cancer types;

3. Once effective, it can allow patients with advanced cancer to survive for a long time and even achieve clinical cure.

Therefore, immunotherapy has become a "special" drug for tumor patients and has also become a hot spot in global research and development!

Four years ago, when the first PD-1 keytruda was launched in China, the annual cost reached 300,000 yuan. Most domestic families could not afford it and could only wait for the drug. What is exciting for domestic patients is that in recent years, the research and development of anti-tumor drugs in China has developed rapidly, and independently developed immunotherapy drugs have emerged rapidly. Since the first domestically produced PD-1 toripalimab was launched in 2018, in just four years, In 2019, we have ushered in the ninth domestically produced PD-1/L1 drug.

is the world’s first model! The “cancer killer” bispecific antibody cardunilimab is launched in China!

There are currently 15 types of PD-1/L1 on the market worldwide, including 7 types listed in the United States and 8 types listed in China. But what is unsatisfactory is that PD-1/L1 only works in 20% to 30% of patients. Oncologists around the world are vigorously developing new immunotherapies with better efficacy and longer survival for cancer patients. .

China is the first to hear the good news!

On June 29, the official website of the National Medical Products Administration of China (NMPA) recently announced that the PD-1/CTLA-4 bispecific antibody candonilimab injection (Candonilimab, code-named AK104) independently developed by Kangfang Biological ) was approved for marketing for patients with recurrent or metastatic cervical cancer who have failed previous platinum-containing chemotherapy. At the same time, it also has a well-known name--Kaitani®!

Kaitanil® is the world's first approved dual immune checkpoint inhibitor dual antibody for tumors. It is completely independently developed by China. This new type of immunotherapy with better efficacy has created a new era of dual immunotherapy and will bring more benefits to cancer patients. Bringing new hope of “healing”!

On June 29, the latest announcement on the official website of China’s National Medical Products Administration was that the PD-1/CTLA-4 bispecific antibody cardunilimab injection independently developed by Kangfang Biologics was approved for marketing. Patients with recurrent or - DayDayNews

China National Medical Products Administration (NMPA) official website

Why is cardenilimab more effective in anti-cancer?

Most patients who are concerned about immunotherapy have heard of the name of immunogemini O+Y (nivolumab + ipilimumab). The combination of these two immune drugs can be said to be a golden partner in the fight against cancer, spanning more than ten major cancer types, and has once again raised the response rate and efficacy of immunotherapy to a higher level. Because studies have found that the combination of these two drugs can simultaneously block the two signaling pathways of PD-(L)1 and CTLA-4, shows synergistic anti-tumor activity and will achieve a 1+1> cancer-killing effect!

However, when two drugs are superimposed, the corresponding risk of adverse reactions will increase.

Cardunilimab injection is a bispecific antibody targeting human PD-1 and CTLA-4. It is equivalent to installing two precision missile heads on a weapon, which can block PD-1 at the same time. The interaction with CTLA-4 and its ligands promotes tumor-specific T cell immune activation, thereby exerting a stronger anti-tumor effect without producing more side effects, achieving better efficacy and controllable safety. Ideal anti-cancer effect. The good news is that a number of new immunotherapies that are on the market and under research at home and abroad are undergoing clinical trials in China. Patients who want to know about new immunotherapies can contact the Medical Department of Global Oncology Doctor Network.

On June 29, the latest announcement on the official website of China’s National Medical Products Administration was that the PD-1/CTLA-4 bispecific antibody cardunilimab injection independently developed by Kangfang Biologics was approved for marketing. Patients with recurrent or - DayDayNews

Which patients is cardenilimab suitable for?

The domestically approved indications of cardunilimab are: Patients with recurrent or metastatic cervical cancer who have failed platinum-containing chemotherapy (R/M CC) .

In addition, Cardunil is also undergoing clinical research in the first-line treatment of cervical cancer and advanced gastric or gastroesophageal junction adenocarcinoma. We also look forward to the early availability of these two indications. Batch, bringing more choices to patients.

What is the therapeutic effect of cardenilimab?

The approval of Caitani® was based on a pivotal clinical study involving patients with recurrent or metastatic cervical cancer (R/M CC) who had failed platinum-containing chemotherapy. According to the latest data presented at the 2022 American Society of Gynecological Oncology (SGO) annual meeting:

Among 100 patients in the entire population (regardless of PD-L1 expression positive or negative) who can be evaluated for efficacy, the objective response rate (ORR) is 33 .0%, with a complete response (CR) rate of 12.0%! This means that nearly 1/3 of patients with advanced refractory disease have significantly reduced lesions after receiving treatment, and 1/10 patients have lesions that completely disappear!

In addition, among PD-L1 positive (CPS ≥ 1) patients, the objective response rate (ORR, the proportion of patients with tumor shrinkage of more than 30%) is as high as 43.8%!

What is the price of cardenilimab? Although the drug

is good, patients are most concerned about the price. The price of this drug has not yet been announced. However, with the launch of more domestic PD-1 drugs, coupled with tilted medical insurance and aid policies, the price of immune drugs in China has dropped to less than a thousand yuan. For example, the price of 80 mg of toripalimab is only 906.08 yuan. , breaking the lowest PD-1 record! It also makes PD-1 inhibitors, which were originally high-end “magic drugs”, really become a treatment option within reach for patients!

reveals good news here. After cardunilimab is approved, it is very likely that it will participate in national medical insurance negotiations in the second half of the year, with a view to entering the medical insurance catalog. Let us look forward to it together.

blossoms and bears fruit! Many new immunotherapies open the door to long-term survival for patients!

In the past decade, cancer immunotherapy has made great progress, reversing the survival time of advanced patients. In addition to immune checkpoint inhibitors such as CTLA-4, PD-1/L1, LAG-3, and many other new drugs are being developed around the world. Under development, such as TIGIT inhibitors, TIM-3 inhibitors, etc. We hope these good medicines will be available as soon as possible to benefit patients.

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