After the authorized transaction in October this year, domestic veteran pharmaceutical company Hansen Pharmaceuticals once again teamed up with multinational pharmaceutical company GSK (GlaxoSmithKline) on ADC (antibody conjugated drugs).
On December 20, Hansen Pharmaceutical announced that Shanghai Hansen Biomedical Technology Co., Ltd., a wholly-owned subsidiary of the Group, had entered into a license agreement with GlaxoSmithKline Intelligent Property (No. 4) Limited to grant the latter a global exclusive license for the development, production and commercialization of HS-20093 (excluding Chinese Mainland, Hong Kong, Macao and Taiwan). Among them, the licensee is a wholly-owned subsidiary of GSK.
According to the mutual agreement, Hansen Pharmaceuticals will receive a down payment of $185 million and is eligible to receive a milestone payment of up to $1.525 billion. In addition, after the commercialization of HS-20093, the licensee will also pay a tiered royalty fee for global net sales outside mainland China, Hong Kong, Macau, and Taiwan.
However, on December 21st, the stock price of Hansen Pharmaceuticals rose slightly at the opening and quickly declined, falling 11.44% as of the press release of HKD 13.320 per share.
By comparison, the amount of this transaction exceeded the level of transactions in October this year. At that time, Hansen Pharmaceuticals granted GSK the rights to the ADC pipeline HS-20089 targeting B7-H4 within the same regional scope, with a down payment of $85 million and a maximum milestone payment of $1.485 billion.
In addition, even among all the domestic innovative drugs going global this year, the transaction amount is impressive enough, second only to the transactions between Baili Tianheng and BMS (HER3/EGFR dual antibody ADC), Chengyi Biotechnology and AstraZeneca (small molecule GLP-1R agonist), as well as the transactions between Baili Sikang and HER2 ADC.
Overall, GSK has included Hansen Pharmaceuticals' two clinical stage ADCs, with a total down payment of 265 million US dollars and a maximum total amount of 3.275 billion US dollars, which also demonstrates GSK's determination to expand into the ADC field.
In fact, GSK has not only missed the COVID-19 vaccine in the advantageous fields in the past two years, but also made rather poor progress after returning to the tumor field in 2016. Among them, the PD-1 product Jemperli and PARP inhibitor Zejula did not meet expectations. In addition, its world's first BCMA targeted drug, Blerep, which was approved for market acceleration, is also an ADC drug, but it was delisted in December 2022 due to failed validation clinical trials. So, GSK may hope to bet on success in this round of ADC wave to boost the cancer field.
Hansen Pharmaceuticals is seen as a representative of traditional pharmaceutical companies transitioning from imitation to innovation. Based on the latest performance, its revenue in the first half of this year was 4.511 billion yuan, of which innovative drugs contributed 2.786 billion yuan, accounting for over 60%. In terms of treatment field, the revenue in the anti-tumor field is 2.555 billion yuan, accounting for more than half of the total revenue. The first domestically produced third-generation EGFR-TKI Amitinib has become the top single product. In addition, the company also has 8 technology platforms, including emerging drug types such as dual antibodies, ADC, siRNA, fusion proteins, PROTAC, etc.
Specifically for trading products, HS-20093 and HS-20089 respectively target B7-H3 and B7-H4, which are relatively new targets. The HS-20093 for this transaction is currently in Phase II clinical stage, with indications covering osteosarcoma, soft tissue sarcoma, castration resistant prostate cancer, solid tumors, head and neck squamous cell carcinoma, small cell lung cancer (SCLC), and esophageal cancer.
At this year's ASCO (American Society of Clinical Oncology) annual meeting, the results of the Phase I study (ARTEMIS-001) of the drug showed that among 11 SCLC patients who had previously received an average of third line treatment, the ORR (objective response rate) of HS-20093 was 63.6%, the DCR (disease control rate) was 81.8%, the median PFS (progression free survival) was 4.7 months, and the 3-month progression free survival rate was 72.7%. Hansen Pharmaceuticals believes that the drug has shown promising clinical efficacy, particularly in SCLC patients.
It is worth mentioning that in October of this year, Merck also purchased three ADC products from the First Three Companies for a total amount of up to $22 billion, including the DS7300, which also targets the B7-H3. At present, the SCLC indications for DS7300 are also in the clinical stage II. In other words, HS-20093 and DS7300 can be described as "close combat". On the other hand, GSK's purchase of HS-20093 at this time also demonstrates its recognition of Hansen's products and ADC platform.
However, in addition to the aforementioned two products, there are many players laying out this target. According to the Dingxiangyuan Insight database, MacroGenics has products in clinical phase II/III among ADCs worldwide. Subsequently, a number of domestic biotech companies such as Yilian Biotechnology, Maiwei Biotechnology, Xinda Biotechnology, Yingen Biotechnology, and Minghui Pharmaceuticals also had their products in the clinical stage I/II.
Additionally, as of now, no drugs targeting B7-H3 have been approved globally. In October 2022, due to limited clinical benefits, Y-mAbs Therapeutics B7-H3 monoclonal antibody Omburtamab's BLA (Biological Product License Application) for neuroblastoma was not approved by the US Food and Drug Administration (FDA).
In addition, in July 2022, due to safety risks, MacroGenics terminated the phase II clinical study of B7-H3 monoclonal antibody Enoblituzumab for head and neck squamous cell carcinoma. This drug was jointly developed by MacroGenics and Biotech Biotech in China. This indicates the development risks on the B7-H3 target.