Pharma Frontiers: Daily Digest of Global Pharmaceutical News – Sep 14

1.Hengrui Pharmaceuticals' HER2 ADC Marketing Authorization Application Accepted

On September 13, Hengrui Pharmaceuticals announced that its marketing authorization application for SHR-A1811 (Rykuntrukin Alfa, an anti-HER2 ADC) was accepted by the NMPA and has entered priority review. It is indicated for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations who have previously received at least one systemic therapy. The phase II clinical trial of SHR-A1811 for HER2-mutated NSCLC reached its primary endpoint of efficacy in June 2024. SHR-A1811 is the first ADC new drug from Hengrui Pharmaceuticals to file for market approval. It has obtained six breakthrough therapy designations, covering low HER2-expressing recurrent or metastatic breast cancer, HER2-positive recurrent or metastatic breast cancer, advanced NSCLC with HER2 mutation after failure of platinum-based chemotherapy, HER2-positive colorectal cancer after failure of therapies that include oxaliplatin, fluorouracil, and irinotecan, HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma after failure of at least one anti-HER2 therapy, and HER2-positive, unresectable or metastatic biliary tract cancer after receiving at least one treatment regimen.

2.Roche's PD-L1 Monoclonal Antibody Subcutaneous Injection Approved for Market in the US

On September 13, Genentech, a member of the Roche Group, announced that atezolizumab (a PD-(L)1 inhibitor) for subcutaneous injection has been approved by the FDA. This marks it as the first and only PD-(L)1 inhibitor in the US designed for subcutaneous injection. It is approved for all the adult intravenous indications of atezolizumab in the US, which include certain types of lung cancer, liver cancer, skin cancer, and soft tissue sarcoma. The intravenous formulation of atezolizumab (brand name: Tecentriq) was first approved in the US in May 2016. Following positive data from the IMscin001 study, atezolizumab in its subcutaneous formulation (brand name: Tecentriq SC) was first approved in the European Union in August 2023. This subcutaneous form of atezolizumab, developed in collaboration with Halozyme Therapeutics’ Enhanze drug delivery technology, reduces the treatment duration to approximately 7 minutes compared to 30-60 minutes for the intravenous version, and helps decrease pain or discomfort for patients during administration.

3.Gilead Announces Promising Clinical Outcomes for Long-Acting HIV Therapy, Aiming for Market Release Next Year 

On September 13, Gilead Sciences announced that, based on the interim analysis of the second pivotal Phase 3 PURPOSE 2 trial, 99.9% of patients receiving their biannual injectable HIV-1 capsid inhibitor, lenacapavir, did not contract HIV. The efficacy in preventing HIV infection was superior to the existing daily oral therapy. Given these positive results, the independent Data Monitoring Committee (DMC) recommended halting the blind phase of the trial at the interim analysis and offering open-label lenacapavir to all participants. According to the press release, Gilead expects to submit a global regulatory filing for lenacapavir by the end of 2024, supporting its market launch in 2025 as the first biannual HIV prevention option.

4.Akeso Biopharma/Chia Tai Tianqing Announce Phase 3 Clinical Data for PD-1 Monoclonal Antibody as First-line Treatment for Liver Cancer

On September 13, 2024, the ESMO (European Society for Medical Oncology) conference website disclosed new breakthrough abstracts (Late-breaking Abstract, LBA). Among these, the Phase 3 study ALTN-AK105-III-02, researching Akeso Biopharma and Chia Tai Tianqing's investigational anti-PD-1 antibody Penpulimab in combination with Anlotinib as a first-line treatment for advanced hepatocellular carcinoma (aHCC), was selected for this year's LBA and will be reported in a Proffered Paper session. The ALTN-AK105-III-02 study, which compares Anlotinib combined with Penpulimab against sorafenib in first-line treatment of advanced HCC, focuses on two primary endpoints: progression-free survival (PFS) and overall survival (OS). As of June 5, 2023, based on the final analysis, the Anlotinib + Penpulimab group significantly improved median PFS (6.9 months vs. 2.8 months compared to the sorafenib group). As of January 29, 2024, in the interim analysis of OS, the Anlotinib + Penpulimab group showed a significantly extended median OS (16.5 months vs 13.2 months compared to the sorafenib group). Earlier in August, Chia Tai Tianqing had already communicated with the CDE about the new indication for first-line treatment of advanced hepatocellular carcinoma and received written consent from the CDE, planning to submit a market application soon. This will also be the 10th indication for Anlotinib hydrochloride capsules and the 5th indication for Penpulimab injection to be filed for market approval.

5.Hengrui Pharmaceuticals' Small Molecule GLP-1 Enters Phase III Clinical Trial

On September 13, the clinical trials registration and information public display platform revealed that Shandong Suncadia Medicine, a subsidiary of Hengrui Pharmaceuticals, has initiated a randomized, double-blind, Phase III study. The study assesses the efficacy and safety of HRS-7535 in comparison to Dapagliflozin in adult Type 2 diabetes patients who have failed to achieve adequate glycemic control after treatment with metformin. This marks the first domestically produced small molecule GLP-1R agonist to enter Phase III clinical trials, following closely behind Eli Lilly's small molecule GLP-1R agonist, orforglipron. HRS-7535 has completed a Phase I trial in healthy individuals in China, involving both single and multiple doses (HRS-7535-101). As the first published oral small molecule GLP-1 receptor agonist Phase I clinical study in China, the data from HRS-7535-101 indicate that HRS-7535 is well-tolerated with favorable safety and pharmacokinetic profiles, supporting once-daily dosing. Notably, even at a relatively low baseline weight (67.6 kg), a significant weight reduction of 4.38 kg was observed after 4 weeks of continuous dosing with HRS-7535 tablets.

6.Biokin Pharmaceutical Files IND for Another ADC New Drug

On September 13, according to the CDE official website, Biokin Pharmaceutical's Class 1 new drug, BL-M08D1 injection, has its clinical trial application accepted. This drug is an ADC (Antibody-Drug Conjugate), intended for the treatment of solid tumors, with its specific targets not yet disclosed. Since the start of 2024, Biokin Pharmaceutical has seen several new ADC drugs advance in research. Among these, the injection forms of BL-M08D1, BL-M14D1, BL-M17D1, and BL-B16D1 were filed for an IND for the first time in 2024, with their specific targets still undisclosed. Additionally, the clinical trial applications for injection form BL-M07D1, and BL-B01D1 were approved before 2024.

7.Summit Therapeutics Secures $235 Million to Accelerate Clinical Development of AK112

On September 13th, Summit Therapeutics Inc. announced that it has accepted offers from several leading biotechnology institutions and individual investors to purchase approximately 10.35 million shares of common stock at $22.70 per share, resulting in total proceeds of approximately $235 million. This financing was completed without the involvement of investment banking fees. All 16 executives of Summit participated in this round of financing. Insiders raised a total of $79 million, including contributions from Robert W. Duggan, Dr. Maky Zanganeh, Manmeet S. Soni, Bhaskar Anand, and board member Jeff Huber, who invested through a controlled entity. The remaining $156 million was raised by several leading biopharmaceutical institutional investors. Summit intends to use the net proceeds to advance the clinical development of ivonescimab, including the development for non-small cell lung cancer and other indications beyond lung cancer based on data presented at ESMO, potentially including but not limited to colorectal cancer and triple-negative breast cancer.

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