Interface News reporter |
Interface News Editor |Xie Xin
SubsequentlyAuthorized in October this yearFollowing the deal, Hansoh Pharma, a veteran Chinese pharmaceutical company, has once again partnered with GSK (GlaxoSmithKline) in the ADC (Antibody-Drug Conjugate) field.
On December 20, Hansoh Pharma announced that its wholly-owned subsidiary, Shanghai Hansoh BioMedical Co., Ltd., entered into a licensing agreement with GlaxoSmithKline Intellectual Property (No.4) Limited. The agreement grants the latter an exclusive global license (excluding mainland China, Hong Kong, Macao, and Taiwan) for the development, manufacture, and commercialization of HS-20093. The licensee is a wholly-owned subsidiary of GSK.
According to the agreement between both parties, Hansoh Pharma will receive an upfront payment of $185 million and is eligible to receive up to $1.525 billion in milestone payments. Additionally, following the commercialization of HS-20093, the licensee will also pay tiered royalties on global net sales outside of mainland China, Hong Kong, Macao, and Taiwan.
However, on December 21, the share price of Hansoh Pharma opened slightly higher and then quickly fell. As of the time of writing, it was trading at HK$13.320 per share, a sharp drop of 11.44%.
By contrast, the transaction amount this time exceeds the level of the transaction in October this year. At that time, Hansoh Pharma granted GSK the rights to the ADC pipeline HS-20089 targeting B7-H4 within the same regional scope, with an upfront payment of 85 million US dollars and a maximum milestone payment of 1.485 billion US dollars.
Moreover, even amidst this year's wave of all domestically-produced innovative drugs going global, the transaction value of this deal remains strikingly impressive, second only toBaili Tianheng and BMS(HER3/EGFR bispecific ADC), Eternity Bio and AstraZeneca (small molecule GLP-1R agonist), and BrightGene and Eisai (HER2 ADC) deals.
In total, GSK has acquired two clinical-stage ADCs from Hansoh Pharma for an upfront payment of $265 million, with a potential total deal value reaching up to $3.275 billion, demonstrating GSK's strong commitment to the ADC field.
In fact, GSK has not only missed the opportunity in the COVID-19 vaccine within its areas of strength over the past two years, but also faced considerable setbacks in the oncology field since its return in 2016. Specifically, its PD-1 product Jemperli and PARP inhibitor Zejula both fell short of expectations. Additionally, its globally first-in-class BCMA-targeted drug, which was granted accelerated approval, also encountered challenges.BlenrepIt is also an ADC drug, but due toVerificationFailed in clinical trials and was withdrawn from the market in December 2022. Therefore, GSK may hope to succeed in the current wave of ADCs to boost its presence in the oncology field.
Hansoh Pharma is regarded as a representative of traditional pharmaceutical companies transitioning from imitation to innovation. In terms of the latest performance, in the first half of this year, its revenue was 4.511 billion yuan, of which innovative drugs contributed 2.786 billion yuan, accounting for more than 60%. In terms of therapeutic areas, revenue from the oncology field was 2.555 billion yuan, accounting for more than half of the total revenue, with Almonertinib, the first domestically developed third-generation EGFR-TKI in China, becoming the top-selling product. Additionally, the company has eight technology platforms, including emerging drug types such as bispecific antibodies, ADC, siRNA, fusion proteins, and PROTAC.
Specifically, in terms of the products involved in the transaction, HS-20093 and HS-20089 target B7-H3 and B7-H4 respectively, both of which are relatively new targets. The HS-20093 involved in 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 Phase I study (ARTEMIS-001) of the drug showed that in 11 SCLC patients who had previously received an average of three lines of treatment, HS-20093 demonstrated an ORR (Objective Response Rate) of 63.6%, a DCR (Disease Control Rate) of 81.8%, a median PFS (Progression-Free Survival) of 4.7 months, and a 3-month progression-free survival rate of 72.7%. Hansoh Pharma believes that the drug has shown promising clinical efficacy, particularly in SCLC patients.
It is worth mentioning that in October this year, Merck also reached a total amount of up to 22 billion US dollars.Purchased the three ADC products from Daiichi Sankyo., including DS7300, which also targets B7-H3. Currently, the SCLC indication for DS7300 is also in Phase II clinical trials. In other words, HS-20093 and DS7300 are in "close competition." On the other hand, GSK's purchase of HS-20093 at this time also demonstrates its recognition of Hansoh Pharma's products and ADC platform.
However, apart from the aforementioned two products, there are many players targeting this point. The Dingxiangyuan Insight database shows that, within the global range of ADCs,MacroGenicsSome products are in Phase II/III clinical trials. Subsequently, a number of China-based biotech companies, including Yilian Biologics, Mabwell, Innovent Biologics, DualityBio, and Minghui Pharmaceuticals, also have products in Phase I/II clinical trials.
Additionally, as of now, no drugs targeting B7-H3 have been approved globally. Notably, in October 2022, Y-mAbs Therapeutics' B7-H3 monoclonal antibody Omburtamab for neuroblastoma did not receive approval from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) due to limited clinical benefit.
In addition, in July 2022, based on safety risks, MacroGenicsTerminationB7-H3 Monoclonal Antibody EnoblituzumabHead and Neck Squamous Cell CarcinomaThe Phase II clinical study. The drug was jointly developed by MacroGenics and China's biotech I-Mab Biopharma. These all indicate the development risks associated with the B7-H3 target.