CPhI Pharma Online (4.5-4.9)

The drug news that shocked the industry this week was that FibroGen admitted to changing the parameters of the cardiac safety data of roxastat in patients with chronic kidney disease anemia, which means that roxastat may not be superior to darpoetin alpha
.

This week’s review includes review, listing and 3 other sections.

Review

NMPA

Listed

1.
On April 6, the official website of NMPA showed that the application for the listing of Huadong Medicine's 4 generic drug Mirabegron sustained-release tablets (acceptance number: CYHS1900699) was changed to "under review", and it will be approved for listing in the near future, which will become the first domestic imitation.

.

Mirabegron is the first approved β3 receptor agonist for overactive bladder (OAB), which selectively relaxes the bladder detrusor and promotes urine by acting on β-adrenergic receptors (β-ARs) Storage, thereby increasing bladder capacity and prolonging the interval between urination

2.
On April 7, the NMPA official website showed that the third indication of AstraZeneca's osimertinib mesylate tablet application (acceptance number: JXHS2000150/JXHS2000151) has been changed to "approval completed-pending certification", that is The indications for adjuvant treatment of non-small cell lung cancer (NSCLC) adult patients with epidermal growth factor receptor (EGFR) sensitive mutations after tumor resection have been approved
.

3.
On April 7th, the official website of NMPA showed that Junshi Bio-Treplimumab Injection's third indication listing application (acceptance number: CXSS2000018, CXSS2000019) has been changed to "Approval completed-pending certification" , That is, the indication for the treatment of locally advanced or metastatic urothelial carcinoma (UC) that has been treated in the past has been approved
.

       4.
On April 7, the official website of NMPA showed that the new drug listing application of Takeda icatibant acetate injection in China (acceptance number: JXHS2000083) has been changed to "approval completed-pending certification", that is, the product has been approved It is used to treat acute attacks of hereditary angioedema (HAE) in adults, adolescents and children ≥2 years of age
.

       clinical

       5.
On April 6, Hengrui issued an announcement that the new class 1 drug SHR8008 capsules was approved for Phase 3 clinical trials.
It was used to evaluate the effectiveness and safety of SHR8008 capsules in the treatment of acute vulvovaginal candida disease (VVC).
Blind double simulation, fluconazole parallel control, multi-center phase III clinical study
.

SHR8008 is a new type of oral azole antifungal drug

       6.
On April 6, Hengrui Class 1 new drug HRS2543 tablets were approved for clinical use in the treatment of advanced malignant tumors
.

HRS2543 inhibits cell proliferation and exerts anti-tumor effects by inducing cycle arrest of tumor cells

       7.
On April 7, Hengrui issued an announcement that its 2.
2 class of modified new drug HR19042 capsules was approved for clinical use, and its indication is the treatment of primary IgA nephropathy
.

Primary IgA nephropathy is a group of clinical syndromes with immunopathological features dominated by IgA deposition in the glomerular mesangial area.

       8.
On April 6, Haisco Pharmaceuticals issued an announcement that its wholly-owned subsidiary Sichuan Haisco independently developed a drug clinical trial application for HSK29116 powder for the treatment of relapsed and refractory B-cell lymphoma
.

This is the world's first BTK-PROTAC approved for clinical use

       9.
On April 6, CDE's official website showed that the BPI-421286 capsule of Betta Pharmaceuticals was approved for clinical use
.

BPI-421286 is a new type of potent and highly selective covalent irreversible KRASG12C oral small molecule inhibitor independently developed by Betta.

       10.
On April 6, Deqi Pharmaceuticals announced that NMPA has approved ATG-019 to carry out a phase I clinical trial application, aimed at evaluating ATG-019 (single agent or combined with niacinER) in patients with advanced solid tumors or non-Hodgkin's lymphoma in China Safety and tolerability
.

ATG-019 is a dual-target inhibitor of PAK4/NAMPT with oral bioavailability

       11.
On April 7, CDE's official website showed that the application for clinical trial of the new drug HEC88473 injection developed by Dongyang Sunshine had obtained the default permission, and it planned to carry out clinical research on type 2 diabetes and weight loss
.
HEC88473 is the first GLP-1/FGF21 dual agonist approved for clinical use in China
.

       12.
On April 7, Junshi Biopharmaceuticals issued an announcement that the clinical application of its self-developed anti-CTLA-4 monoclonal antibody JS007 injection has been accepted, which is mainly used for the treatment of advanced malignant tumors
.
JS007 can specifically bind to CTLA-4 and effectively block the interaction between CTLA-4 and its ligand B7 (CD80 or CD86), thereby activating T lymphocytes and inhibiting tumor growth
.

       13.
On April 8, the CDE official website showed that Kangfang Biologics Class 1 new drug AK120 injection was approved for clinical use, and the indication is moderate to severe atopic dermatitis.
This is the first time that the drug has been approved for clinical use in China
.
AK120 is a new type of autoimmune disease treatment drug that targets IL-4R independently developed by Kangfang Biology.
It inhibits the biological activity of dual cytokines IL-4 and IL-13 to achieve clinical treatment of allergic autoimmune diseases.

.

       Priority review

       14.
On April 7, the CDE official website revealed that Bayer’s application for Copanlisib’s listing in China is intended to be included in priority review for the treatment of relapsed or refractory follicular lymphoma (FL) that has received at least two systemic treatments in the past.
) Adult patients
.
Copanlisib is an intravenously injected phosphatidylinositol-3-kinase (PI3K) inhibitor.
It has inhibitory activity on both PI3K-α and PI3K-δ subtypes expressed in malignant B cells
.

       FDA

       15.
On April 6, the FDA announced the full approval of Gilead’s Trop-2ADC product Trodelvy for use in adult patients with metastatic triple-negative breast cancer who have previously received at least two therapies
.
Trodelvy is a First-in-class anti-Trop-2ADC drug.
It is the core product of Immunomedics.
Gilead acquired the product in September 2020 with a large-scale acquisition of Immunomedics for US$21 billion
.

       16.
On April 9, Immutep announced that the US FDA has granted the company’s candidate therapy eftilagimod alpha fast track qualification as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
.
Eftilagimod alpha is a soluble LAG-3 fusion protein
.

       European Union

       17.
On April 6, Ganli Pharmaceuticals announced that it had received an official written reply from the European Commission, granting it an orphan drug designation for the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor GLR2007 under development for the treatment of gelatin.
Mass tumor
.
GLR2007 is an innovative small molecule CDK4/6 inhibitor independently developed by Ganli Pharmaceutical.
It is intended to be used for the treatment of various advanced solid tumors including glioma
.

       Listed

       18.
On April 8, the Hong Kong Stock Exchange disclosed the IPO prospectus of Tengsheng Bo Pharmaceutical.
The prospectus disclosed that Teng Sheng Bo Pharmaceutical was founded in December 2017.
The products include a combination of independent research and development and external introduction.
The product treatment direction includes such as Major infectious diseases such as hepatitis B, AIDS, MDR/XDR gram-negative bacterial infections, and central nervous system diseases and other diseases that have a major public health burden
.

       19.
On the evening of April 8, the Hong Kong Stock Exchange disclosed the IPO prospectus of Connoa Biosciences.
Its core product is a highly effective, humanized antagonistic antibody CM310 against interleukin 4 receptor α subunit (IL-4Rα).
, Can double block the signal transduction of interleukin 4 (IL-4) and interleukin 13 (IL-13)
.

       other

       20.
On April 6, FibroGen issued a statement clarifying the previously disclosed data of the Phase 3 clinical safety analysis of Roxadustat (Roxadustat) in the treatment of chronic kidney disease anemia (CKD)
.
New data shows that Roxadustat may not be superior to darpoetin alpha in reducing the risk of adverse cardiovascular events in patients
.