Monthly News Review of PharmaSources (February) - R&D

In R&D, Chipscreen chidamide Ⅲ test reaches preset indicators, the company plans to submit an application for the marketing of a new indication; In business, Abbisko gives Allist the rights to develop, manufacture and commercialize a next-generation of EGFR TKI in China in a USD 180 million deal.

R&D

1. On February 20, the CDE official website revealed that Pfizer's first-in-class PF-06821497 was approved to be a clinical development candidate for treating advanced malignant tumors, including small cell lung cancer (SCLC), castration-resistant prostate cancer (CRPC) and follicular lymphoma. PF-06821497 is a EZH2 inhibitor under clinical development, and is not approved for marketing in any country or region around the world.

2. On February 21, the CDE official website revealed that Hangzhou Zhongmeihuadong Pharmaceutical Co., a wholly owned subsidiary of Huadong Medicine, Huadong Medicine has submitted a clinical trial application of first-in-class PRV-3279, together with Provention Bio. It is an investigational humanized bispecific antibody targeting CD32b and CD79b. Huadong Medicine has obtained the exclusive rights to develop and commercialize PRV-3279 in Greater China for its two clinical indications by nearly USD 190 million.

3. On February 22, the CDE official website revealed that the application for the marketing of a new indication of Sanofi's Dupilumab Injection was approved for priority review to treat adults with prurigo nodularis. Dupilumab is an anti-IL-4/IL-13 monoclonal antibody, the first and only biological preparation used in the treatments of Dermatology, Respiratory, and allergic reactions. Currently, the approved indications include atopic dermatitis, asthma, prurigo nodularis, eosinophilic esophagitis (for patients aged 12 years and older), chronic rhinosinusitis with nasal polyposis (CRSwNP).

4. On February 22, the CDE official website revealed that Mavacamten introduced by LianBio is intended to be included in the priority review procedure for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in cardiac function class II-III classified by New York Heart Association (NYHA). Mavacamten is a first-in-class cardiac myosin inhibitor.

5. On February 22, Drug Clinical Trial Registration and Information Publicity Platform of CDE showed that Eli Lilly launched a global multi-center phase III clinical trial (including China) to investigate the safety and efficacy of remternetug in patients with symptomatic alzheimer's disease via subcutaneous injection. Remternetug is an antibody new drug, targeting N3pG beta amyloid.

6. On February 27, the CDE official website revealed that Johnson & Johnson's Guselkumab monoclonal antibody injection was intended to be included as a drug of breakthrough therapy in adults with moderately to severely active Crohn's disease (CD). Guselkumab monoclonal antibody is the world's first approved interleukin 23 (IL-23) inhibitor, targeting cytokines inhibiting IL-23, which plays a crucial role in autoimmune diseases.

7. On February 27, the CDE official website revealed that, Novartis's LNP023 capsule (iptacopan) was intended to be included as a drug of breakthrough therapy in patients with paroxysmal nocturnal hemoglobinuria (PNH). Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, chronic, complement-mediated disease of the blood. Iptacopan is a first-in-class oral inhibitor developed by Novartis, targeting factor B, a component of the alternative pathway of complement activation.

8. On February 28, the CDE official website revealed that Kamari Pharma submitted a clinical trial application for KM-001 cream and was processed. KM-001 is a new drug for treating pruritus in development and it's also a TRPV3 inhibitor. TRPV3 is an ion channel protein and is thought to play important roles in many physiological processes.

9. On March 1, Zhejiang Medicine announced that, after reviewing the interim results, the independent data monitoring committee (IDMC) informed that ACE-Breast-02 met its pre-specified interim primary efficacy endpoint with statistical significance. ZMC-ARX788-211 or ACE-Breast-02 is a randomized, open-label, controlled multi-center phase Ⅱ/Ⅲ clinical trial of humanized anti-HER2 monoclonal antibody-AS269 conjugate (ARX788, an anti-HER2-ADC (antibody-drug conjugate), developed by its subsidiary, Novocodex Biopharmaceuticals) in the treatment of HER2 positive patients with locally advanced or metastatic breast cancers in China.

10. On March 1, Inovio announced the latest positive results from phase Ⅲ clinical trial (Reveal 2) of VGX-3100 (ABC-3100), the world's first therapeutic DNA vaccine. ApolloBio has exclusive rights to develop, produce and commercialize VGX-3100 within China. Though the efficacy endpoint of the investigational biomarker-selected population (25 participants) did not achieve statistical significance, trial results did achieve statistical significance in the all-participants (203) population with histologically-confirmed and clearance of virus. At the secondary endpoint of clearance of virus, the viral clearance of VGX-3100 group is significantly higher than that of the placebo group.

11. On March 1, Chipscreen announced that a phase III DEB study of subtype selective Histone deacetylase (HDAC) oral inhibitor chidamide for the treatment of diffuse large B-cell lymphoma (DLBCL) has completed the interim analysis. The drug is independently developed by the company. Upon evaluation, IDMC believed that the trial met the preset efficacy and safety indicators, and suggested the applicant to submit a marketing application with attached conditions in advance.

12. On March 2, the CDE official website revealed that Hengrui Pharmaceuticals's first-in-class HRS-8427 was approved for the clinical treatment of pulmonary infections. HRS-8427 injection plays the antibacterial and the sterilization role by inhibiting the biosynthesis of cell walls. A preclinical study showed that it has antibacterial efficacy in multiple standard strains and established mouse models of infections from clinically separated strains with good safety. At present, there's no similar product approved for marketing in China.