In this week, in terms of drug review and approval, a new indication of Pfizer's tofacitinib sustained release tablet was approved in China; In terms of R&D, Phase III study of obesity indication of Eli Lilly's Tirzepatide succeeded in China; In terms of business, Ji Xing Pharmaceuticals acquires a global interest of the cardiovascular innovative product PB6440.

The news review in this week is from February 6 to 10, covering 3 sections, i.e. drug review and approval, R&D and business.

Drug review and approval

- NMPA

1. On February 9, the NMPA official website revealed that a new indication of Pfizer's Tofacitinib Citrate Sustained Release Tablets was approved for marketing. Tofacitinib is a JAK inhibitor developed by Pfizer, with approved indications worldwide for rheumatoid arthritis, ulcerative colitis, psoriatic arthritis, juvenile idiopathic arthritis and ankylosing spondylitis.

2. On February 8, the CDE official website revealed that the marketing application of the Category 5.1 new drug, Tafluprost/Timolol Maleate Eye Drops, developed by Santen, had been submitted and accepted. It is a fixed-dose compound eye drops without any preservative, which proposed indication is to lower the intraocular pressure in patients with open-angle glaucoma and ocular hypertension. Tafluprost/Timolol Maleate Eye Drops is an eye compound formulation, with the PG derivative which is the first-line therapeutic drug of glaucoma, but without the preservative.

3. On February 9, the CDE official website revealed that the marketing application of the Category 5.1 new drug, Ciprofloxacin Hydrochloride and Fluocinolone Acetonide Ear Drops, developed by Laboratorios Salvat and Lee's Pharm's subsidiary Zhaoke Pharmaceutical, had been submitted and accepted. The Ear Drops is a product treating the otitis, which has been approved for marketing in numerous countries and regions, such as America, Canada, Europe and Hong Kong, S.A.R., China.

4. On February 10, the CDE official website revealed that the marketing application of the first-in-class, Fotagliptin Benzoate Tablets, developed by Salubris, had been submitted and accepted. Fotagliptin is a DPP-4 inhibitor, with a rapid oral absorption, a long half-life period, a long-lasting effect and other characteristics, which target indication is the Type 2 diabetes.

5. On February 9, the CDE official website revealed that AstraZeneca had submitted the clinical trial application of ravulizumab, which is the drug's second clinical trial application declared in China. Ravulizumab, a long-acting complement C5 inhibitor, developed by the complement field's leading enterprise Alexion (it has been acquired by AstraZeneca), which has been approved initially by FDA for marketing in December 2018, is used for treating the paroxysmal nocturnal hemoglobinuria (PNH).

6. On February 9, the CDE official website revealed that Biogen had submitted the clinical trial application of aducanumab (Aduhelm) for treating the early AD, which is its first application for the clinical treatment in China. Aducanumab is a human IgG1 monoclonal antibody with a high affinity and targeting-Aβ conformation epitope. It can selectively bind with the amyloid protein deposition in AD patients' brain, and remove the protein deposition by activating the immune system.

7. On February 9, the CDE official website revealed that Hinova Pharma had submitted the clinical trial application of HP530S tablet for treating the solid tumor. HP530S tablet, a highly-active and highly selective focal adhesion kinase (FAK) inhibitor, independently researched and developed by the Hinova Pharma, can inhibit metastasis, proliferation and angiogenesis of tumor cells by inhibiting FAK and adjusting its downstream signaling pathway.

- FDA

8. On February 8, the Inmagene announced that Phase I clinical trial application (IND) of its IMG-008 had been approved by FDA. IMG-008, as the first long-acting IL-36R-targeted antibody to enter the clinical phase in the world, with a longer half-life period and higher exposure compared with the traditional IL-36R antibody, can offer a treatment plan for various inflammatory diseases, such as Generalized Pustular Psoriasis (GPP) and Hidradenitis Suppurativa (HS).

Priority review

9. On February 8, Vision Biotechnology announced that FDA had granted WSD0628, which can penetrate the blood-brain barrier, Orphan Drug Designation for the treatment of malignant gliomas. WSD0628, an ATM-targeted inhibitor penetrating the blood-brain barrier, is planned to develop as a radiotherapy sensitizer combining the radiotherapy for nerve center metastasis of brain glioblastoma (GBM), anaplastic glioma (AA) and other tumors.

- EMA

10. On February 6, Huahui Health registered a Phase II clinical trial (NCT05713318) on the website clinicaltrials.gov to evaluate the efficacy and safety of its self-developed nasal spray HH-120 in the treatment of mild SARS-CoV-2 infection. HH-120 is an angiotensin converting enzyme 2 (ACE2) Fc fusion protein.

Clinical data

11. On February 9, Immvira Pharma announced that its first oncolytic virus product for intratumoral injection, MVR-T3011 IT, had shown a positive result in the Phase II clinical project in China/America, that is monotherapy can significantly prolong the progression-free survival (PFS) of the advanced melanoma patients with a fail immunotherapy. As of January 2023, the median PFS is up to 12.9 months.

Business

12. On February 6, Ji Xing Pharmaceuticals announced that they had acquired a global interest of PhaseBio's PB6440 through asset purchase. PB6440, as a new generation, highly selective aldosterone synthase inhibitor, is a new candidate drug in the preclinical phase, intending for the treatment need that is not satisfied in the cardiovascular field including hypertension.

13. On February 8, Sihuan Pharm announced its subsidiary Jilin Sihuan's cooperation with Wangshi Biomedical, Junshi Biosciences's shareholding subsidiary, on the production and supply of the Deuremidevir Hydrobromide Tablets (Product Code: VV116), an oral nucleoside first-in-class against COVID-19. Under the agreement of the parties, Jilin Sihuan, as the entrusted producer, will cooperate with Wangshi Biomedical to carry out technology transfer and production, including the product process optimization, quality method transfer, pilot scale-up, process validation and so on, and registration and approval of entrusted production.

14. On February 9, Gloria Pharmaceuticals and Huahui Health jointly announced that they would build a cooperative relationship on clinical research. The two companies will carry out clinical research on combined therapy of Gloria Pharmaceuticals's anti-PD-1 monoclonal antibody, Zimberelimab Injection, and Huahui Health's anti-TIGIT monoclonal antibody, HH-101 Injection, evaluating the effectiveness and safety of the combined therapy in the patients with multiple solid tumors.

About  the Author:    

Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.