Novartis Launches Phase III Trial of Hydroxychloroquine for COVID-19; BeiGene Submits New Indication Application for Tislelizumab in First-Line Advanced Squamous NSCLC

New Horizon Health Completes $20 Million Series D Financing, Continuing to Lead the Field of Early Cancer Screening

On April 21, 2020, New Horizon Health, a pioneer in the field of early cancer screening in China, announced the completion of a $20 million Series D financing round. The round was led by Omniscience Capital, a private equity fund focused on healthcare investments, and participated by existing shareholders Qiming Venture Partners, SoftBank China, and Duke University Management Company, as well as Exome Asset Management, a U.S.-based healthcare fund. The proceeds from this financing will be used to develop new product pipelines, continue investing in large-scale clinical studies, further upgrade service systems, and strengthen brand marketing, with the aim of maintaining its leadership in the field of early cancer screening.

Sanofi’s Breakthrough Cardiovascular Drug Praluent® Launches in China

On April 19, Sanofi announced the launch of alirocumab injection (brand name: Praluent®) in China. As a lipid-lowering agent in the class of PCSK9 inhibitors, Praluent® provides an important new treatment option for the large population of patients in China with suboptimal control of atherosclerosis, particularly by reducing the risk of major adverse cardiovascular events (MACE) and all-cause mortality. Concurrently, the “Care for Praluent – Praluent Patient Assistance Program” was officially launched to help patients with acute coronary syndrome (ACS) better manage their disease and associated risks.

Hainan Simcere’s Cefaclor for Suspension Passes Consistency Evaluation

On April 20, Simcere Pharmaceutical announced that its subsidiary, Hainan Simcere Pharmaceutical Co., Ltd., had received the “Approval for Supplementary Drug Application” from the National Medical Products Administration (NMPA). With this approval, Simcere’s Cefaclor for Suspension became the first product in China to pass the consistency evaluation. According to available data, Cefaclor for Suspension (brand name: Zaike) is primarily indicated for respiratory, urinary, ear-nose-throat, and skin and soft tissue infections caused by susceptible organisms. It features a broad spectrum of activity, a favorable safety profile, high compliance among pediatric patients, and a bioavailability of up to 95%.

Huabang Pharmaceutical’s “Tadalafil Tablets” Receive Drug Registration Approval for the Indication of Erectile Dysfunction

On April 21, Enhua Pharmaceutical announced that its wholly-owned subsidiary, Chongqing Huapont Pharmaceutical Co., Ltd., had recently received the "Drug Registration Approval" for the chemical drug "Tadalafil Tablets," issued by the National Medical Products Administration (NMPA). The announcement stated that tadalafil is a selective and reversible phosphodiesterase type 5 (PDE5) inhibitor indicated for erectile dysfunction (ED), with two additional potential indications: benign prostatic hyperplasia and pulmonary arterial hypertension.

Baiyunshan’s Subsidiary Tianxin Pharmaceutical Receives Approval for Aztreonam for Injection

On April 20, Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd. announced that its controlled subsidiary, Tianxin Pharmaceutical, received the Drug Registration Approval (Approval Nos.: 2020S00188, 2020S00187) issued by the National Medical Products Administration on April 17, 2020. It is reported that Aztreonam for Injection was developed by Bristol-Myers Squibb Company in the United States, and the original branded product has not been marketed in China. The indications for Aztreonam for Injection include the treatment of various infections caused by susceptible aerobic Gram-negative bacteria. This drug is classified as a Category B product under the 2019 edition of the National Reimbursement Drug List.

Beigene Submits Tislelizumab for Approval as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer

On April 21, 2020, BeiGene announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) had accepted its supplemental New Drug Application (sNDA) for a new indication of BAIZEAN® (tislelizumab injection), an anti-PD-1 antibody, in combination with two chemotherapy regimens for the first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC). Currently, there are 15 potential registrational clinical trials of BAIZEAN® underway in China and globally, including 11 Phase 3 trials and four pivotal Phase 2 trials. BAIZEAN® has not yet been approved in countries or regions outside of China, nor has it been approved for the treatment of non-small cell lung cancer.

Ascendis Pharma’s New Hypoparathyroidism Drug TransCon PTH Eliminates Need for Standard Care After 4 Weeks of Treatment

Recently, Danish biopharmaceutical company Ascendis Pharma announced positive top-line results from the four-week, fixed-dose, double-blind portion of its global Phase II PaTH Forward trial evaluating TransCon PTH, a long-acting prodrug of parathyroid hormone (PTH). The trial is assessing the safety, tolerability, and efficacy of TransCon PTH in adult patients with hypoparathyroidism (HP). Results showed that the trial met its primary endpoint, demonstrating that four weeks of TransCon PTH therapy eliminated the need for standard-of-care treatment (active calcium plus vitamin D) in up to 82% of patients.

Bristol Myers Squibb and Exelixis Announce Success of Phase 3 Study of Opdivo in Combination with Cabozantinib for the Treatment of Renal Cell Carcinoma

On April 20, BMS and Exelixis announced positive first-line results from the pivotal Phase III CheckMate -9ER study. The study primarily evaluated the efficacy and safety differences between Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) versus sunitinib as first-line treatment for advanced or metastatic renal cell carcinoma (RCC). Results from the prespecified interim analysis demonstrated that the CheckMate -9ER study met its primary endpoint of improved progression-free survival (PFS), as well as secondary endpoints of improved overall survival (OS) and objective response rate (ORR). Regarding safety, no unexpected adverse events were observed.

Bristol Myers Squibb’s Opdivo Combined with Yervoy Meets Primary Endpoint in Phase 3 Trial for First-Line Treatment of Malignant Pleural Mesothelioma

On April 20, Bristol Myers Squibb (BMS) announced that the pivotal Phase 3 CheckMate-743 trial, evaluating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for previously untreated malignant pleural mesothelioma (MPM), had met its primary endpoint of overall survival (OS). According to a pre-specified interim analysis conducted by an independent data monitoring committee, the combination of Opdivo and Yervoy demonstrated a statistically significant and clinically meaningful improvement in OS compared with chemotherapy (pemetrexed plus cisplatin or carboplatin).

Idorsia’s Dual Orexin Receptor Antagonist Daridorexant Shows Positive Key Phase 3 Clinical Results

On April 21, pharmaceutical developer Idorsia announced that its dual orexin receptor antagonist, daridorexant, achieved positive top-line results in its first pivotal Phase 3 clinical trial involving 930 adult and elderly patients with insomnia (39.1% aged ≥65 years). The study confirmed the efficacy of daridorexant in improving both objective and subjective sleep parameters as well as daytime functioning, with no residual effects in the morning and no evidence of rebound or withdrawal symptoms upon treatment discontinuation.

Alexion Pharmaceuticals Initiates Phase III Study of Complement C5 Antibody for the Treatment of Severe COVID-19 Patients

On April 20, US pharmaceutical company Alexion announced the initiation of a global Phase III study to evaluate the efficacy of Ultomiris (ravulizumab-cwvz) in critically ill adult patients hospitalized with severe pneumonia or acute respiratory distress syndrome (ARDS) due to COVID-19. The study is scheduled to launch in May and will enroll 270 patients, who will be randomized in a 2:1 ratio to receive either Ultomiris or best supportive care. The primary endpoint is 29-day survival rate, while secondary endpoints include duration of mechanical ventilation, duration of oxygen therapy, length of ICU stay, length of hospital stay, and safety.

Novartis Launches Phase III Study of Hydroxychloroquine for the Treatment of COVID-19 Patients

Recently, Novartis announced that it has reached an agreement with the U.S. FDA to conduct a Phase III clinical trial evaluating the efficacy of hydroxychloroquine in treating hospitalized patients with coronavirus disease 2019 (COVID-19). The trial will enroll approximately 440 patients, and the hydroxychloroquine will be supplied by Sandoz, Novartis’s generics and biosimilars division. The study will be conducted at more than ten sites across the United States.

Sunovion’s Breakthrough Schizophrenia Drug SEP-363856 Achieves Success in Pivotal Clinical Study

Recently, Sunovion Pharma, the U.S. subsidiary of Japan’s Sumitomo Pharma (Sunovion), announced that the results of SEP361-201, a pivotal 4-week study evaluating the TAAR1 agonist SEP-363856 for the treatment of schizophrenia, have been published in the New England Journal of Medicine, a leading international medical journal. The study results demonstrated that the total score on the Positive and Negative Syndrome Scale (PANSS) was significantly improved in the SEP-363856 treatment group compared with the placebo group. In this study, the effects of SEP-363856 on extrapyramidal symptoms, body weight, and other metabolic parameters (including blood lipids, glycated hemoglobin, and prolactin) were similar to those observed in the placebo group.

Biotech Firm Genome&Company’s Anti-Cancer Microbiome Therapeutic GEN-001 Receives FDA IND Approval

On April 21, 2020, the biotechnology company Genome&Company announced that the U.S. Food and Drug Administration (FDA) had accepted its Investigational New Drug (IND) application for GEN-001, to be used in combination with avelumab (BAVENCIO®) for the treatment of patients with solid tumors. Avelumab is an anti-PD-L1 antibody jointly developed and commercialized by Merck KGaA, Darmstadt, Germany, and Pfizer Inc. Following this approval, Genome&Company will serve as the sole sponsor to conduct the first-in-human clinical trials in Asia, pioneering the combination therapy of anticancer microbiota with anti-PD-1/anti-PD-L1 agents.

Roche Upgrades Ocrevus Regimen for Multiple Sclerosis, Reducing Intravenous Infusion Time from 3.5 Hours to 2 Hours

Recently, Roche announced that regulatory applications for its multiple sclerosis drug Ocrevus (ocrelizumab) have been accepted by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The submission pertains to a 2-hour infusion regimen for Ocrevus, administered twice yearly for the treatment of patients with relapsing forms of multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The FDA and EMA are expected to render approval decisions by the end of 2020. If approved, the infusion time for Ocrevus would be reduced from the current 3.5 hours to 2 hours.

Harbour BioMed Announces First Patient Dosed in Phase 1b/2a Clinical Study of Batoclimab

On April 21, Harbour BioMed announced that the first patient had been enrolled and dosed in its Phase 1b/2a clinical study of batoclimab (HBM9161), a fully human anti-FcRn antibody, for the treatment of neuromyelitis optica spectrum disorders (NMOSD). This clinical study aims to evaluate the safety, tolerability, pharmacodynamics, and efficacy of batoclimab (HBM9161) in Chinese patients with NMOSD. It is also the first global study of an anti-FcRn targeted therapy in NMOSD.

AstraZeneca’s Koselugo Shows Significant Efficacy in Neurofibromatosis Type 1, Continuously Reducing Tumor Volume

Recently, the results of the open-label Phase II SPRINT Stratum 1 trial (NCT01362803), which evaluated AstraZeneca’s targeted anticancer drug Koselugo (selumetinib) for the treatment of symptomatic, inoperable plexiform neurofibromas (PNs) in pediatric patients with neurofibromatosis type 1 (NF1), were published online in the New England Journal of Medicine, a premier international medical journal. Data from the SPRINT Stratum 1 trial demonstrated that Koselugo provided significant clinical benefits, including sustained tumor volume reduction, pain relief, and improvements in daily functioning and overall health-related quality of life.

Pfizer’s TYK2 Inhibitor PF-06826647 Tablets Filed for Clinical Trial Approval in China

On April 20, the Center for Drug Evaluation (CDE) accepted Pfizer’s clinical trial application in China for PF-06826647, a TYK2 inhibitor tablet. This drug is currently in Phase I/II clinical trials globally. No TYK2 inhibitors have yet been approved for marketing worldwide. The most advanced competitor, BMS-986165, has entered Phase III clinical trials and has obtained approval for three clinical trials in China, targeting plaque psoriasis, Crohn’s disease, and lupus nephritis, respectively.

2020 List of Best Workplaces in the U.S. Biopharmaceutical Industry Released, with Genentech Ranking First

Recently, Fortune magazine released its list of the Best Workplaces in the U.S. Biopharma Industry for 2020, with Genentech (a member of the Roche Group), Novo Nordisk, and AbbVie ranking in the top three. Other biopharmaceutical companies featured on the list include Horizon Therapeutics, United Therapeutics, Acorda Therapeutics, Exact Sciences, Harmony Biosciences, Accent Therapeutics, and Boston Pharmaceuticals.

Boehringer Ingelheim’s Aservo® EquiHaler® Wins Red Dot Award for Outstanding Design Quality

On April 21, 2020, Boehringer Ingelheim announced that Aservo® EquiHaler® had received the Red Dot Product Design Award. Aservo® EquiHaler® is an inhalation therapy for severe equine asthma that has received marketing authorization from the European Commission.

《PLoS Pathog》: Study Shows Antiviral Drug Baloxavir Reduces Viral Transmission

A recent community-based study published in PLOS Pathogens by Aeron Hurt of Roche, Wendy Barclay of Imperial College London, and their colleagues demonstrates that baloxavir treatment reduces the transmission of influenza virus from infected ferrets to healthy ones, suggesting that this antiviral drug may help control early influenza outbreaks by limiting viral spread. As the authors note, this is the first evidence indicating that the rapid reduction in infectious viral particles associated with baloxavir treatment translates to a lower risk of influenza transmission to contacts.

Journal of Hepatology: Researchers Elucidate Complex Immune Evasion Mechanisms in Multifocal Hepatocellular Carcinoma

Recently, the team led by Gao Qiang from Zhongshan Hospital, Fudan University, in collaboration with the team led by Wu Kui from BGI-Shenzhen, published a research paper online in the international gastroenterology and hepatology journal Journal of Hepatology. In this study, the research team collected 47 tumor samples, along with corresponding adjacent non-tumor tissues and peripheral blood samples, from 15 patients with multifocal hepatocellular carcinoma (HCC). By employing high-throughput technologies—including deep whole-exome sequencing, transcriptome sequencing, T-cell receptor (TCR) sequencing, immunopeptidomics, and multiplex immunofluorescence—combined with functional immune assays, the researchers elucidated the immuno-genomic landscape of multifocal HCC and its heterogeneous immune escape mechanisms. Their findings validated an immunotherapeutic strategy that leverages the adaptive characteristics of the local immune response microenvironment to overcome the genetic complexity inherent in multifocal hepatocellular carcinoma.