Chinese pharmaceutical companies enter overseas to record with up to $5 billion in licensing fees!

Akeso announced that it has granted Summit Therapeutics an exclusive license to AK112 in the United States, Canada, Europe and Japan, and Dr. Yu Xia, chairman of Akeso, will be appointed as a member of Summit Therapeutics' board of directors.

The total value of the transaction is expected to reach $5 billion, with a down payment of up to $500 million, and Akeso will also receive a low double-digit percentage of net sales as a royalty for Evesi!

As soon as the news came out, the industry was shocked, and the highest intraday stock price rose by more than 37%, and the transaction volume also set a new record for China's local innovative drug license-out.

Licensing fees are as high as $5 billion

How effective is Iwosi?

Evocimab is a PD-1/VEGF bispecific antibody and the world's first PD-1/VEGF bispecific antibody to enter phase III clinical studies. Evocimab, developed as AK112, blocks the binding of PD-1 to PD-L1 and PD-L2, and at the same time blocks the binding of VEGF to VEGFR. The combination therapy of PD-1 antibody and VEGF blocker has shown strong efficacy in a variety of tumors (non-small cell lung cancer, renal cell carcinoma and hepatocellular carcinoma), and anti-VEGF and anti-PD-1 can both modulate the tumor immune microenvironment, so the combination of the two drugs may exert the effect of 1+1>2. Evoxi may have advantages in terms of treatment convenience and patient dependence.

Evesi currently has two Phase III trials underway, namely the Phase III head-to-head study of AK112 versus pembrolizumab monotherapy for PD-L1-positive NSCLC (NCT05499390), and the Phase III study of AK112 plus chemotherapy versus chemotherapy in EGFR-TKI-resistant EGFR-mutant advanced NSCLC (NCT05184712).

Published data show that in the phase 1b/II trial (NCT04900363) of Evosi's single-agent first- or second-line treatment of advanced non-small cell lung cancer, 96 patients with advanced NSCLC were enrolled in four dose groups of 10mpk Q3W, 20mpk Q2W, 20mpk Q3W and 30mpk Q3W. In 54 PD-L1-positive patients, an overall response rate (ORR) of 60.0% was obtained; In patients with PD-L1 expression > 50%, the PR was 76.9%. Whether Ewoxi single drug can prevail compared with K drug, the OS and PFS of the third stage are the gold standard for testing.

In another Phase II clinical trial (NCT04736823) of evoci plus docetaxel in patients with NSCLC, 83 NSCLC patients were enrolled in three subgroups, untreated EGFR/ALK wild-type patients, EGFR-positive EGFR-TKI resistant advanced patients, and PD-(L)1 plus platinum-based therapy progression. EGFR-TKI-resistant advanced patients had a total ORR of 68.4% and a median progression-free survival (mPFS) of 8.2 months, compared with 4.3 months for historical controls with current standard therapy (pemetrexed and platinum-containing chemotherapy).

Beyond lung cancer

Iwosi's multi-faceted "medicine" raw

Evesi has been recognized as a breakthrough therapy by the National Medical Products Administration of China, including first-line treatment of PD-L1-positive (TPS≥1%) locally advanced or metastatic NSCLC, combination chemotherapy versus chemotherapy in EGFR-TKI-resistant EGFR-mutated advanced non-squamous NSCLC, and docetaxel in combination with docetaxel for patients with previously PD-(L)1 inhibitors and platinum-containing chemotherapy for patients with locally advanced or metastatic NSCLC.

In addition to lung cancer, the drug is also deployed in indications such as ovarian cancer, endometrial cancer, liver cancer, triple-negative breast cancer and metastatic colon cancer.

A rising biopharmaceutical star

In addition to Ewosi, there are three drugs of cardunilib (PD-1/CTLA-4, already on the market), AK131 (PD-1/CD73 biantibody), AK129 (PD-1/LAG3) and AK130 (TIGIT/TGF-β) bispecific antibodies are also worth paying attention to.

Cardunilimab (AK104, PD-1/CTLA-4 dual antibody, trade name: Kaitanil) is the first domestic bispecific antibody approved by NMPA and the world's first new tumor dual immune checkpoint biantibody. Under the poor environment this year, Kaitani still achieved sales revenue of about 300 million yuan in the first half of the year. Akeso expects the first full annual sales of Kaitani to reach 1 billion yuan. In the next 2-3 years, the company has almost no competitors in the field of cervical cancer, and it is believed that Catani will reach a peak sales of 3 billion yuan in this time period. It is worth mentioning that the drug will participate in the 2022 medical insurance negotiations, and if it enters the medical insurance catalog, Akeso's stock price is bound to rise to a new level.

In addition to dual antibody products, Akeso's AK117 (CD47 monoclonal antibody) has also attracted much attention, which is expected to overtake multinational pharmaceutical giants and become a first-in-class new drug.

Akeso has also developed new drugs with popular targets such as PCSK9, IL-4R, IL-12/IL-23, IL-17, VEGFR-2, and TIGIT. In addition, Akeso has also laid out some new fields, including cell therapy, ADC, neurological diseases, etc., while ensuring the leading position of bispecific antibodies, it has also set foot in more innovative drug forms that may give birth to blockbuster drugs.

The end-to-end comprehensive drug development platform (ACE platform) established by Akeso since its inception has produced many original products for Akeso, and has also allowed Akeso to retain the license-out opportunity. In 2015, the company licensed CTLA-4 monoclonal antibody AK107 (Quavonlimab, MK1308) to Merck for a total consideration of $200 million, which made Akeso a hit. Now, Akeso has licensed PD-1/VEGF dual antibody Ewosi to Summit for a total amount of up to $5 billion, making history again. Akeso also has about 10 new drugs in international clinical trials, and there is still no lack of license-out opportunities in the future.

Biotech's most important thing is its ability to innovate, and at present, Akeso has established a rich and competitive R&D pipeline and is growing into a biopharmaceutical superstar.