Sinopharm's Subsidiary Sihuan Pharma Secures NMPA Approval for Three New Drugs Amid China CDC’s Release of Largest 70,000-Case COVID-19 Analysis

Westlake University Successfully Determines the Spatial Structure of the Cellular Receptor for SARS-CoV-2

Recently, the laboratory of Professor Qiang Zhou at Westlake University successfully resolved the full-length structure of ACE2, the receptor for the novel coronavirus, using cryo-electron microscopy. This marks the first time in the world that the full-length structure of ACE2 has been resolved. The related research findings were posted on the preprint platform bioRxiv at around 3:00 a.m. Beijing time on February 19. This achievement also represents a significant outcome of the emergency scientific and technological research tasks undertaken by Westlake University for the prevention and control of novel coronavirus pneumonia in Zhejiang Province.

Chinese CDC Releases Analysis of 70,000 Cases for the First Time

On February 17, the Chinese Center for Disease Control and Prevention released the largest-to-date epidemiological analysis of COVID-19, based on raw data from more than 70,000 cases reported in mainland China as of February 11, 2020. The corresponding paper was published in the Chinese Journal of Epidemiology. The paper concluded that, as of February 11, the epidemic situation in China was trending downward, but the outbreak had not yet ended. It emphasized the need to continue effectively implementing case detection and management at the community and workplace levels to prevent a resurgence of the epidemic after work resumption. Unresolved issues in current research include identification of animal hosts, determination of the infectious period, elucidation of transmission routes, and development of effective treatments and preventive measures (including the development of rapid diagnostic tests, as well as drugs and vaccines).

Large-scale transcriptomic studies reveal significantly elevated expression of the 2019-nCoV receptor gene ACE2 in smokers

Recently, Guoshuai Cai, an Assistant Professor at the University of South Carolina, uploaded a research paper to the preprint platform medRxiv. Through analysis of four large-scale transcriptomic datasets based on normal lung tissue, the study found no significant differences in the expression of the ACE2 gene, the receptor for 2019-nCoV, across race (Asian vs. Caucasian), age (>60 years vs. <60 years), or sex (male vs. female). However, ACE2 gene expression was elevated in smokers. Furthermore, the author discovered that ACE2 gene expression occurred in specific cell types associated with smoking history and the anatomical site of smoke exposure.

Biotech Firm Imara Plans $86 Million IPO to Advance PDE9 Inhibitor for Sickle Cell Disease

Recently, Imara, a company dedicated to developing therapies for sickle cell disease and thalassemia, announced its plan to raise $86 million through an initial public offering (IPO) to further advance the clinical development of its lead candidate for treating sickle cell anemia. IMR-687, developed by Imara, is a signaling protein that inhibits phosphodiesterase 9 (PDE9), thereby improving cyclic GMP levels and reactivating fetal hemoglobin expression to alleviate anemia symptoms. Currently, IMR-687 is undergoing Phase 2 clinical trials to evaluate its safety and efficacy in patients with sickle cell anemia.

Pharmaceutical Company BioCryst Announces FDA Acceptance of New Drug Application for Berotralstat for the Prevention of Hereditary Angioedema Attacks

Recently, biopharmaceutical company BioCryst announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for berotralstat (BCX7353), a once-daily oral medication for the prevention of hereditary angioedema (HAE) attacks. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of December 3, 2020. In the NDA acceptance letter, the FDA stated that it does not currently intend to convene an advisory committee meeting to discuss the NDA.

Merck Announces FDA Rejection of Six-Week Dosing Regimen for Keytruda

On February 18, Merck & Co. announced that the U.S. Food and Drug Administration (FDA) had issued Complete Response Letters (CRLs) for the six supplemental Biologics License Applications (sBLAs) it had submitted. These six sBLAs sought to update the dosing frequency of Keytruda to include a once-every-six-weeks (Q6W) regimen, specifically: 400 mg administered via intravenous infusion over no less than 30 minutes every six weeks, for multiple therapeutic indications. Currently, the FDA-approved dosing regimen for Keytruda in the United States is 200 mg every three weeks. If the Q6W regimen is ultimately approved, it will provide a more patient-friendly treatment option for cancer patients in the U.S. by reducing the frequency of administration, thereby offering greater treatment flexibility for both patients and oncologists.

FDA Grants Priority Review to Roche’s Application for Tecentriq Monotherapy as First-Line Treatment for Lung Cancer

On February 19, Roche announced that the U.S. Food and Drug Administration (FDA) had accepted its supplemental Biologics License Application (sBLA) for Tecentriq (atezolizumab) as a first-line (initial) monotherapy for patients with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) who have high PD-L1 expression (TC3/IC3 wild-type [WT]) and lack EGFR or ALK mutations, as determined by PD-L1 biomarker testing. The FDA also granted Priority Review designation to this application, with a target action date of June 19, 2020.

Pfizer Announces EU Approval of Vyndaqel for the Treatment of Adult Patients with ATTR-CM

Recently, Pfizer announced that the European Commission (EC) has approved Vyndaqel (tafamidis), a once-daily 61 mg oral capsule for the treatment of adult patients with wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM). Prior to this approval, treatment options for patients with ATTR-CM were limited to symptom management and, in rare cases, heart (or combined heart and liver) transplantation. Vyndaqel is the first and only drug approved in the EU for the treatment of ATTR-CM, and the only one proven to reduce mortality and cardiovascular-related hospitalizations in patients with wild-type or hereditary ATTR-CM.

Novartis’ PI3Kα Inhibitor BYL719 for Breast Cancer Clinical Application Accepted by CDE

On February 19, Novartis’ clinical trial application for BYL719 in China was accepted by the Center for Drug Evaluation (CDE). This new drug had just received FDA approval on May 24, 2019, under the brand name Piqray. BYL719 (alpelisib) is a PI3Kα inhibitor. Its first approved indication is in combination with fulvestrant for postmenopausal women with HR-positive, HER2-negative, PI3Kα-mutated advanced breast cancer who have experienced disease progression following endocrine therapy. It is the first PI3Kα inhibitor approved for the treatment of breast cancer.

Betta Pharmaceuticals’ Innovative Drug BPI-27336: Clinical Trial Application Accepted

On February 19, Beta Pharma announced that the National Medical Products Administration (NMPA) had accepted its Investigational New Drug (IND) application for BPI-28592, a candidate therapy for patients with solid tumors. According to the announcement, BPI-28592 is a novel molecular entity compound independently developed by Beta Pharma, with full independent intellectual property rights. It is a new-generation, potent, and highly selective oral small-molecule inhibitor of tropomyosin receptor kinase (TRK), also known as neurotrophin receptor tyrosine kinase (NTRK). The drug is designed to target multiple cancer types and is intended for the treatment of patients with locally advanced or metastatic solid tumors harboring NTRK gene alterations.

NMPA Accepts New Drug Application for Yuheng Biopharma’s Sipalimab Injection

On February 18, 2020, Guangzhou Yuheng Biotechnology Co., Ltd. announced that the National Medical Products Administration (NMPA) had formally accepted its New Drug Application (NDA) for the investigational recombinant fully human anti-PD-1 monoclonal antibody, zimberelimab injection (formerly known as GLS-010 injection), for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (r/r cHL) in the second-line setting or beyond.

Sihuan PharmaceuticalRivastigmine Bitartrate Capsules Granted Drug Production Approval

On February 18, Sihuan Pharmaceutical announced that the Rivastigmine Hydrogen Tartrate Capsules developed by the Group had received the Drug Production Approval issued by the National Medical Products Administration of the People's Republic of China. The approved strengths of Rivastigmine Hydrogen Tartrate Capsules are 1.5 mg and 3.0 mg, indicated for the treatment of mild to moderate Alzheimer’s disease dementia. The Group obtained the production approval for Rivastigmine Hydrogen Tartrate Capsules as a new chemical drug under Category 4, becoming the first company in China to market this product after passing the consistency evaluation.

Sihuan Pharmaceutical’s Levetiracetam Tablets Receive Drug Production Approval

On February 18, Sihuan Pharmaceutical Holdings Group Ltd. announced that its developed levetiracetam tablets had received the Drug Production Approval from the National Medical Products Administration (NMPA) of China. The approved strengths of levetiracetam tablets are 0.25 g and 0.5 g, primarily indicated as adjunctive therapy for partial-onset seizures in adult and pediatric epilepsy patients aged four years and older. As a new-generation broad-spectrum antiepileptic drug, levetiracetam exerts its antiepileptic effects by modulating synaptic vesicle protein SV2A, potassium channels, and N-type calcium channels. It offers advantages such as high bioavailability, linear pharmacokinetics, low plasma protein binding, lack of hepatic enzyme induction, and minimal drug-drug interactions, thereby improving long-term medication adherence and reducing seizure frequency.

Four Rings Pharmaceutical's Midazolam Buccal Mucosal Solution Receives Drug Registration Approval

On February 18, Sihuan Pharmaceutical announced that the midazolam buccal mucosal solution developed by the Group had obtained a drug registration approval. Sihuan Pharmaceutical is the first company in China to receive such approval for midazolam buccal mucosal solution. This formulation is the first mucosal dosage form in China specifically developed for infants, children, and adolescents, indicated for the treatment of acute prolonged convulsive seizures caused by high fever or epilepsy.

Hengrui Initiates Phase III Clinical Trial of Fluzoparib, Alone or in Combination with Apatinib, for Advanced Ovarian Cancer

On February 18, Hengrui Medicine registered the initiation of a Phase III clinical study evaluating fluzoparib or fluzoparib combined with apatinib mesylate versus placebo as maintenance therapy following first-line platinum-based chemotherapy in patients with advanced ovarian cancer. This randomized, double-blind, parallel-controlled Phase III clinical trial plans to enroll 680 patients with advanced ovarian cancer. The primary endpoints are progression-free survival (PFS) assessed by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 criteria, and the type, incidence, grade (determined according to NCI-CTCAE V5.0 criteria), and severity of study drug-related adverse events of Grade 3 or higher.

Specialty Pharmaceutical Company Foamix Announces Strong Efficacy of Topical Antibiotic FMX103 in Treating PPR

Recently, Foamix Pharmaceuticals, a specialty pharmaceutical company, announced the pooled efficacy analysis results from two pivotal Phase III clinical trials of FMX103 (minocycline, 1.5% foam) for the treatment of moderate-to-severe papulopustular rosacea (PPR) in adults at the 2020 South Beach Symposium held in Miami. Currently, the New Drug Application (NDA) for FMX103 for the treatment of moderate-to-severe papulopustular rosacea (PPR) in adults (aged 18 years and older) is under review by the U.S. Food and Drug Administration (FDA). The FDA has set the Prescription Drug User Fee Act (PDUFA) target action date as June 2, 2020.

Roche’s Antisense RNA Therapy RG6042 Granted Orphan Drug Status in Japan for the Treatment of Huntington’s Disease

Recently, Chugai Pharmaceutical, a Japanese pharmaceutical company controlled by the Swiss pharmaceutical giant Roche, announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation (ODD) to its investigational drug RG6042 (formerly known as IONIS-HTTRx) for the treatment of Huntington’s disease (HD). RG6042 is an antisense RNA therapeutic that has been shown to reduce the production of mutant huntingtin protein (mHTT), the root cause of HD, which is produced by the gene associated with Huntington’s disease. Currently, the global Phase III clinical trial of RG6042 (GENERATION HD1) is ongoing.

Biotech Firm Five Prime Therapeutics’ New Drug Fails in Phase II Pancreatic Cancer Trial with Opdivo

On February 18, biotechnology company Five Prime Therapeutics announced that the Phase 2 clinical trial (NCT03336216) evaluating cabiralizumab in combination with Opdivo (nivolumab) for the treatment of advanced pancreatic cancer, conducted in collaboration with Bristol-Myers Squibb (BMS), failed to meet its primary endpoint.

CancerEarly Cancer Screening Company GRAIL Launches First Interventional Clinical Trial

On February 19, GRAIL, a company dedicated to early cancer diagnosis, announced that the U.S. Food and Drug Administration (FDA) had approved its Investigational Device Exemption (IDE) for its liquid biopsy test, officially launching its PATHFINDER clinical study. Currently, the first cohort of participants in this study has completed enrollment. PATHFINDER is GRAIL’s first clinical trial to provide early cancer detection results back to physicians, helping to guide diagnostic workups for more than 50 types of cancer, which may influence treatment decisions.

Hengrui Submits Apatinib for Approval of Its Second Indication: Second-Line Treatment for Liver Cancer

On February 19, the official website of the Center for Drug Evaluation (CDE) disclosed that Hengrui Medicine had submitted a marketing application for the second indication of its Class 1 innovative drug, apatinib, under acceptance number CXHS2000004. The second indication is for the second-line treatment of liver cancer. Apatinib is Hengrui’s second approved Class 1 innovative drug, with sales reaching approximately RMB 1.7 billion in 2018.