Qilu Pharma's Trastuzumab Biosimilar Approved; Daiichi Sankyo, Sinoexcel, and Antengene Announce Key Drug Approvals

Jul 08, 2024 20:30 CST Updated 20:30

Qilu Pharmaceutical

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Daiichi - Sankyo

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1. Qilu Pharmaceutical's "Trastuzumab" Biosimilar Approved for Marketing, Targeting Breast Cancer

On July 5, the official website of China's National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical...Trastuzumab Biosimilar for InjectionThe marketing application has been officially approved. According to the press release previously issued by Qilu Pharmaceutical, this is a product developed by the company.Herceptin Biosimilar (QL1701),Indicated for the treatment of HER2-positive metastatic breast cancerPrior studies have shown that QL1701 is highly consistent with the original product. Trastuzumab can specifically target the extracellular domain of HER2, preventing the activation of intracellular tyrosine kinase and inhibiting the proliferation and survival of HER2-dependent tumor cells. Additionally, it can kill tumor cells through antibody-dependent cell-mediated cytotoxicity (ADCC). The original trastuzumab product, Herceptin, developed by Roche, has previously been approved in China for the treatment of breast cancer and gastric cancer. In September 2019,Qilu Pharmaceutical Launches Trastuzumab (Antuzumab®)Phase I Clinical Study. The results showed that Antruzumab® is bioequivalent to Herceptin®. In April 2020, a Phase III clinical study was initiated. The Phase III study of Trastuzumab (Antruzumab®) is a multicenter, randomized, double-blind, parallel-controlled trial comparing the efficacy and safety of Trastuzumab (Antruzumab®) with Herceptin®, both in combination with Docetaxel, in untreated HER2-positive metastatic breast cancer patients. Conducted across 73 centers in China, the study met its predefined primary endpoint, showing that this product is similar to the originator drug in terms of efficacy, safety, and pharmacokinetics.

2.Daiichi-Sankyo's GABA Analog "Mirogabalin Besylate Tablets" Approved for Marketing in China to Treat Chronic Pain

July 5,Daiichi - SankyoInnovative drugs independently developedDelijing® (Mirogabalin Besylate Tablets, English trade name: Tarlige®)Approved by the National Medical Products Administration for the treatment of diabetic peripheral neuropathic pain in adults. The approval of this indication is an important milestone in the field of diabetic peripheral neuropathic pain, breaking the long-standing treatment困境 and broadening the new landscape of diabetic peripheral neuropathic pain management in China.Delijing®AsThe Third Generation of Calcium Channel ModulatorsIts site of action is the α2δ subunit of calcium ion channels. It has a high affinity for the α2δ subunit but dissociates slowly from the α2δ-1 subunit (more associated with analgesic effects) and quickly from the α2δ-2 subunit (more associated with central adverse reactions), thus achieving a better balance between efficacy and safety. In preclinical studies, it demonstrated stronger and longer-lasting analgesic effects. This approval was based on the results of the DS5565-A-A315 clinical study, a randomized, double-blind, placebo-controlled Phase III clinical trial in China. The trial included 393 participants and aimed to evaluate the efficacy and safety of mirogabalin besylate in treating patients with DPNP. The study results showed that compared to the placebo group, the group receiving 15 mg of mirogabalin twice daily exhibited statistically significant improvement in pain scores at week 14 (P=0.0301). Additionally, there were notable improvements in patients' overall impression of pain, sleep, and quality of life.

3.SALUBRIS DPP-4 Inhibitor "Foglitin" Approved for Marketing in China, for Treatment of Type 2 Diabetes

Recently,SALUBRISAnnouncement: New Diabetes Drug "Foglitinib Benzoate Tablets" (Trade name: "Xinlitin) has obtained the drug registration certificate issued by the National Medical Products Administration. Voglibose Benzoate Tablets (Xinliting) is a dipeptidyl peptidase-4 (DPP-4) Inhibitor, used to improve blood glucose control in adult patients with type 2 diabetes (including monotherapy and combination therapy when metformin hydrochloride alone cannot effectively control blood glucose), a domestically produced Class 1 innovative drug (Project Code: SAL067).Foglitinib Benzoate (Xindatin)InhibitableDPP-4Activity, reducing DPP-4 hydrolysis of incretin hormones, thereby increasing the plasma concentration of the active forms of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), increasing insulin release and lowering glucagon levels in a glucose-dependent manner to reduce blood glucose; characterized by rapid oral absorption, long-lasting effect, high selectivity, and good safety. In October 2023, Sinopharm published the Phase III SAL067-C-009 study results of Fugliflozin for the treatment of type 2 diabetes. This study was a multicenter, randomized, double-blind, placebo-controlled clinical trial (n=458), evaluating the efficacy and safety of Fugliflozin (12mg/day) compared with Alogliptin (25mg/day) and placebo in patients with type 2 diabetes. The primary endpoint was the change in glycated hemoglobin (HbA1c) at week 24 relative to baseline. Results showed that, compared with the placebo group, HbA1c significantly decreased in the Fugliflozin group (-0.70% vs. -0.26%), and Fugliflozin was non-inferior to Alogliptin (-0.70% vs. -0.72%). Additionally, the proportion of patients achieving HbA1c below 7.0% in the Fugliflozin, Alogliptin, and placebo groups were 37.0%, 35.5%, and 15.5%, respectively.

4. Roche's ALK Inhibitor Alectinib Approved for New Indication in China to Treat Non-Small Cell Lung Cancer

On July 5, the latest announcement on the official website of China's National Medical Products Administration (NMPA) showed,Roche(Roche) Alectinib Hydrochloride Capsules New Indication Approved for Marketing. According to the priority review announcement by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration, the indication approved this time is: for adjuvant treatment post complete tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer.AlectinibInitially approved for marketing in the United States in 2015. In August 2018, the drug was approved for marketing in China, as a single agent for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for anaplastic lymphoma kinase (ALK). In April this year, Roche announced that Alectinib (Alecensa) received DFA approval for a new indication, as adjuvant therapy following complete tumor resection in patients with ALK-positive NSCLC. Alectinib has become the first and currently the only approved treatment for early-stage ALK-positive NSCLC patients who have undergone surgical tumor removal.ALK InhibitorPreviously, the positive results of the Phase III clinical ALINA study were announced. The study included a total of 257 participants, with disease-free survival (DFS) as the primary endpoint. The results showed that, in patients with completely resected Stage IB-IIIA ALK-positive NSCLC, Alecensa reduced the risk of disease recurrence or death by 76% compared to the platinum-based chemotherapy group (HR=0.24, 95% CI: 0.13-0.43, p<0.0001). Additionally, an exploratory analysis observed an improvement in central nervous system (CNS) disease-free survival (DFS) (HR=0.22, 95% CI: 0.08-0.58). In terms of safety, the safety and tolerability profile of Alectinib was consistent with previous studies, with no new unexpected safety issues observed.

5. Antengene's XPO1 Inhibitor Selinexor Approved for New Indication, Targeting Diffuse Large B-Cell Lymphoma

On July 5, the official website of China's National Medical Products Administration (NMPA) announced,AntengeneIntroducedOralXPO1InhibitorSelinexorNewThe marketing application for the indication has been approved. According to the priority review announcement by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration, the approved indication for this drug is: applicable for patients who have previously received at least two lines of systemic treatment.Recurrent or refractory diffuse large B-cell lymphoma (DLBCL), including adult patients with DLBCL transformed from follicular lymphoma. SelinexorIt is a targeted drug that works by targetingXPO1To achieve the purpose of treating diseases, it mainly blocks Exportin 1 (XPO1), reversibly inhibiting the nuclear export of tumor suppressor proteins (TSPs), growth regulators, and oncogenic protein mRNAs. It was approved for marketing in the United States by the FDA in 2019, with approved indications including multiple myeloma and diffuse large B-cell lymphoma. Due to its indications and efficacy, it received the "Priority Review" and "Orphan Drug" designations from the U.S. FDA. In July 2022, Selinexor also gained approval from China's National Medical Products Administration (NMPA) and has been included in the medical insurance system. Selinexor was initially developed byKaryopharm TherapeuticsThrough research and development, Antengene has obtained the exclusive rights for the development and commercialization of this product in multiple Asia-Pacific markets, including Greater China and South Korea. Notably, in August 2023,AntengeneAndHansoh PharmaAnnouncement of a Cooperation Agreement on the Commercialization of Selinexor and Products Containing or Composed of Selinexor in Mainland China. Antengene will receive an upfront payment of up to RMB 200 million from Hansoh Pharma, as well as milestone payments of up to RMB 535 million. Selinexor has previously demonstrated encouraging clinical efficacy with good tolerability in the pivotal SADAL study for relapsed or refractory DLBCL. In the SADAL trial targeting various disease subtypes, single-agent oral selinexor achieved an overall response rate (ORR) of 29%, including a complete response rate (CR) of 13%. Notably, some patients experienced sustained responses, with 38% achieving a duration of response lasting six months.

6.Novo Nordisk's Long-Acting Therapy for Hemophilia A, Pegylated Recombinant Factor VIII (Pegrocoagulase Alfa), Approved for Marketing in China

7On the 5th day of the month, the official website of China's National Medical Products Administration (NMPA) announced,Novo NordiskThe marketing application for Pabinafusp Alfa has been officially approved.Injectable Peturocoagulase α(Turoctocog alfa pegol) isNovo NordiskA product developed based on Turoctocog alfaLong-acting Recombinant Coagulation Factor VIII (FVIII)The product was first approved by the FDA in February 2019 for both prophylactic and acute treatment of hemophilia A in adults and children. In February 2019, Powder for Injection Perturocoagulant Alpha received FDA approval in the United States for the prophylactic and acute treatment of hemophilia A in adults and children. The approval was based on clinical trial results involving 270 patients with hemophilia A. Data showed that prophylactic treatment with Powder for Injection Perturocoagulant Alpha (50 IU/kg) administered every four days maintained the annual bleeding rate at a low level of 1.18 times per year. Researchers also conducted a survey among hemophilia A patients using Powder for Injection Perturocoagulant Alpha. Results indicated that patients were more satisfied with this treatment compared to previous therapies, mainly due to reduced infusion frequency, ease of storage, excellent hemostatic efficacy, and improved quality of life.

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