Double Anti selling 546 million yuan! With a total revenue of 1.1 billion yuan in 2022, Kangfang Bio is on the road to a wild ride

Recently, Kangfang Biological released 2022 financial results, annual product sales of 1.104 billion yuan, a year-on-year growth of 422%. Less than half a year after the launch of PD-1/CTLA-4 double anti-cardonilizumab, under the influence of the combined epidemic, the sales volume still increased strongly, reaching 546 million yuan. Dr. Xia Yu, founder and chairman of Kangfang Biological, said at the performance exchange meeting that there was no doubt that Cardonilizumab would reach the target of 1 billion yuan in the first year.

It is expected that in the next 5 years, more than 6 kinds of self-developed new drugs will be listed in China and even the world, to build a product platform of 10 billion.

The revenue of three commercial products is 1.1 billion yuan, and the double antibody is outstanding

At present, Kangfang Biological has 3 commercial products, among which PD-1/CTLA-4 dual anti ketanil (AK104, Cardonilizumab) approved last June achieved sales of 546 million yuan in half a year. PD-1 monoclonal antibody Anichol (Piamprilimab) annual product sales of 558 million yuan; In addition, PD-1 monoclonal antibody (PD-1) Puyouheng (Putrelimab) Kang Fang will also receive milestone payments and a 7% share of sales.

Products under development, Kangfbiol has 6 products, a total of 14 clinical studies in the critical/phase III stage, including the core dual antibody AK104 and AK112 (PD1/VEGF-A dual antibody, Ivosi), Eroccimumab (IL-12/IL-23, AK101) in the field of autopilot, Inucimumab (PCSK9, AK101) in the field of metabolism. AK102) and other potential products.

In 2022, the total investment of Kangfang Biological research and development is 1.323 billion yuan, which corresponds to the company's rapid promotion of multiple R&D pipelines, which is quite thrifty.

Of course, Kang Fang biological is the most concerned or its double resistance pipeline.

AK104 (Cardonilizumab, Ketanyl)

Carak104 is a PD-1/CTLA-4 bi-specific antibody independently developed by Kangfang Biochem. It was approved in China in June 2022 for the treatment of patients with recurrent or metastatic cervical cancer who failed to receive platinum-containing chemotherapy. This is the world's first tumor double immune checkpoint double anti-drug.

With its exclusive advantage in the field of cervical cancer, AK104 rapidly increased its sales volume once it was launched and achieved a sales volume of 546 million yuan in less than half a year, which is highly likely to exceed the management's previous expectation of 1 billion yuan in the first year. It is worth mentioning that Kangfang did not choose to allow AK104 to enter the medical insurance. Instead, after comprehensively considering the difficulty of realizing the price-volume relationship in the medical insurance negotiation, Kangfang adopted the route of drug donation for commercial promotion. At present, the annual treatment cost is 198,000 yuan.

Cervical cancer is only a small indication, and AK104 is currently undergoing phase III clinical trials in stomach cancer, liver cancer, and non-small cell lung cancer. In fact, AK104 is now being used off-label, and cervical cancer now accounts for about a third of Ketanyl sales, according to Dr. Xia. As for the expectation of Kaitani sales peak, Kang Fang biological think there is infinite possibility, is expected to break the curse of 3 billion ~4 billion yuan.

AK112 (Ivosi)

AK112 is another high-weight core dual antibody product developed by Kangfang Biotics, which is PD1/VEGF-A dual antibody. Due to its impressive Phase 2 clinical data, AK112 set a new record by awarding Summit Therapeutics an exclusive license to develop a new drug in the U.S., Europe, Canada, and Japan with a total transaction volume of US $5 billion (US $500 million down payment) and double-digit net sales royalty at the end of last year.

The fastest progress in clinical studies on AK112 is in the field of lung cancer. Currently, 3 clinical studies have entered phase 3, covering the whole population of non-small cell lung cancer. Among them, the Phase 3 registered clinical studies on the head-to-head first-line treatment of AK112 and Pabolizumab in PD-L1+ non-small cell lung cancer have attracted much attention and are looking forward to reading out the data.

Double anti is still short of "explosive", Kang Fang can break the game?

The so-called bisspecific monoclonal antibody (BsAb, short for double antibody) is an antibody formed by combining two different heavy chain amino acids and two different light chain amino acids through chemical coupling, recombinant DNA or cell fusion. Compared with monoclonal antibodies, dual antibody drugs can target two different epitopes and are critical in the treatment of complex diseases.

However, the development of dual antibody is also more difficult. In the long-term development, the industry has gradually formed a consensus that "monoclonal antibody is the target, while dual antibody is the platform".

In 2009, the world's first dual antibody Removab (targeting EpCAM/CD3 for malignant ascites) was approved for market in the European Union, but was discontinued in 2017.

By the end of 2022, a total of eight dual-antibody drugs had been marketed worldwide, of which half (4) were approved in 2022, including Cardonilizumab of Kangfang Bionics.

In terms of market performance, the five disclosed biabs generated revenue of $5.3 billion in 2022, with Roche's Hemlibra dominating the market share of biabs with sales of SFr3.823 billion (approximately $4 billion) in 2022.

The past few years have seen a lot of progress with a huge increase in drug approvals, but they lack a star product like Enhertu (DS-8201, trastuzumab) in the ADC space. Where is Enhertu in the field of dual antibody?

Kang Fang biological is no doubt the domestic double antibody field leader. With its unique TETRABODY technology, Kangfang Biotech has a rich pipeline of innovative dual-antibody products, giving it an unparalleled first-mover advantage.

Although cardonilizumab has only been approved as a second-line treatment for cervical cancer, its launch has shaken the position of K /O drugs in the field of cervical cancer treatment and is widely favored by the market. An industry source said, "Cardonilide is to cervical cancer what DS-8201 is to breast cancer." This statement, although not supported by sufficient data, reflects the expectations of cardonilizumab.

With the promotion of PD-1 antibody cervical cancer indications by Shiyao Group, Qilu Pharmaceutical and other companies, although Kang Fang biological products may lose its exclusive advantage, but the first-mover advantage of Cardonili is still not able to be robbed by other products, and cervical cancer is just the beginning, multiple cancer is the star sea.

The company's other in-development dual anti-PD-1 /VEGF drug, ivoximab (AK112), was launched in December 2022 under a $5 billion license from Summit Therapeutic, a partner whose founders launched blockbuster products such as Ibutinib, The AK112 is now Summit's core asset and is expected to replicate the success of Ibrutinib.

At present, AK112 is carrying out a number of phase III clinical trials of non-small cell lung cancer in China, including first-line therapy of single-drug head-to-head K-drug challenge and second-line therapy of EGFR TKI resistance combined with chemotherapy. If successful, it will not only have great significance for AK112 itself, but also for the whole field of dual antibody. In the United States, SUMMIT is in active communication with the FDA for three major cancer indications and expects to begin Phase III trials soon this year.

Also from the TETRABODY platform, Kangfang Biogas also has AK131(PD-1/CD73), AK129 (PD-1/LAG-3), AK130 (TIGIT/TGF-β), AK132 (Claudin18.2/CD47) and other double antibodies. It is also very likely to replicate the previous success, whether it is self-development or license out will bring great profits to the company.

Explosive products often have advantages such as ① excellent curative effect ② first-mover advantage ③ wide indications and long life cycle. AK104 and AK112 of Kangfang Biological are verifying these characteristics one by one. Whether they can become "explosive products" still needs time to test.

Conclusion

In recent years, the development of new drugs in China has mushroomed rapidly, and the market competition is extremely fierce, especially the cancer track. Therefore, the State Medical Products Administration issued the Guiding Principles for Clinical Research and Development of Anti-tumor Drugs Oriented by Clinical Value, which clearly proposed that new drug research and development should be oriented to patient needs, and monoclonal antibody, ADC and dual antibody drugs are only tools, while clinical value is the purpose.

Whether there is a blockbuster in the dual-antibody space depends on the emergence of a product as effective as Enhertu. AK104, AK112 and others are still waiting to be tested...