Beijing News (Reporter Wang Kara) On March 24, information on the official website of the State Food and Drug Administration showed that Fuhong Henlius’ innovative PD-1 drug slulimumab was approved for single drug use The treatment of unresectable, metastatic highly microsatellite unstable (MSI-H) solid tumors after failure of standard therapy is also the seventh PD-1 monoclonal antibody approved for marketing in China. On the morning of March 25, the stock price of Henlius increased by up to 8.27%, and the stock price fell to HK$21.4/share at the close of noon.
Henlius’ 4 previously approved products are all biosimilars, and slulimumab is its first self-developed PD-1 product, known as It is an “H drug” and is regarded as an important representative product in the transformation from Biotech (biotechnology company) to Biophama (biopharmaceutical company).
Slulimumab has multiple indications under investigation
Slulimab The marketing registration application for limumab monotherapy for the indication of unresectable, metastatic highly microsatellite unstable (MSI-H) solid tumors after failure of standard therapy was accepted by the State Food and Drug Administration in April last year and included in Priority review approval process. This indication is screened based on specific MSI-H tumor markers, not differentiated by cancer types, and covers a wide range of patient groups, so it is also known as a “pan-cancer type” indication in the industry.
The second indication for slulimumab in China is the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer, which is also expected to be approved this year listed. According to the data of the international multi-center Phase 3 clinical study published by Henlius, the combination therapy can significantly prolong the progression-free survival of patients.
Taking the opportunity and foundation of H medicine, Henlius is also conducting 9 clinical trials of immunocombination therapy globally, covering a wide range of lung cancer, esophageal cancer, head and neck cancer and gastric cancer and other high-incidence large tumor species. In December 2021, the phase III study of drug H combined with chemotherapy in the first-line treatment of small cell carcinoma reached the primary endpoint of overall survival. Henlius plans to submit the registration application for this indication in China and the EU in 2022. Drug H is expected to become The world’s first first-line anti-PD-1 monoclonal antibody for the treatment of small cell lung cancer. In addition, Henlius plans to submit a registration application for slulimumab combined with chemotherapy (cisplatin + 5-FU) in the first-line treatment of locally advanced/metastatic esophageal squamous cell carcinoma in China.
With the approval of slulimumab, the commercialization of Henlius will start soon. Henlius introduced in its annual report that in October 2021, the Xuhui base successfully passed the GMP compliance on-site inspection by the Shanghai Food and Drug Administration for the southern line of slulimumab stock solution production, the second line of preparation production, and the first-line packaging area of preparation production.
Many pharmaceutical companies deploy “pan-cancer” indications
MSI-H /dMMR solid tumor treatment is a cutting-edge therapeutic area with a wide range of application scenarios. Previous literature reported that the proportion of MSI-H/dMMR in solid tumor patients ranges from 5% to 15%. In addition to Henlius, many other companies are deploying products for highly microsatellite unstable (MSI-H) solid tumors.
According to Lilac Garden Insight database, high microsatellite instability (MSI-H) cancer cells have more genetic markers than normal cells, which are called “microsatellite instability”. satellite”. They are short repetitive DNA sequences that normally repair mismatched DNA when cells replicate DNA, and cancer cells with a large number of microsatellites may be defective in this function (also known as defective mismatch repair, or dMMR ). MSI-H and dMMR tumors are most commonly seen in colorectal, other types of gastrointestinal, and endometrial cancers, and may also occur in patients with breast, prostate, bladder, and thymic cancers.
Lilac Garden Insight database shows that up to now, including slulimumab, four new drugs have been approved for MSI-H/dMMR solid tumors in China. Among them, there are two approved in 2021, namely Merck’s K drug pembrolizumab (anti-PD-1 monoclonal antibody), and Envolizumab, a collaboration between Simcere Pharmaceuticals/Corning Jereh/Sidi Pharmaceuticals Anti-PD-L1 mAb. The indication of BeiGene’s tislelizumab (anti-PD-1 monoclonal antibody) was just approved in March this year, and the fourth is Henlius’ slulimumab (anti-PD-1 monoclonal antibody). 1 mAb).
In addition, Lepu Bio’s core product, pterizumab (anti-PD-1 monoclonal antibody), has filed for MSI-H/dMMR solid tumors in November last year. month was included in priority review and approval.
There are also corresponding clinical trials in China that are actively exploring this field, including Chia Tai Tianqing/Kangfang Bio’s Piamprimab, and Kangfang Bio’s double-antibody AK104 ( PD-1/CTLA-4), Qilu Pharmaceutical’s anti-PD-1 monoclonal antibody QL1604, etc.
Proofreading Liu Baoqing