CloudBreak Therapeutics Secures RMB 180 Million in New Financing; LinkTech Pharma Closes Tens of Millions USD Series A Round

Boyun Bio Completes New Round of Financing Worth Approximately RMB 180 Million, Advancing Phase III Clinical Trials of Core Ophthalmic Product CBT-001

On April 17, Boyun Bio, an innovative ophthalmic drug developer, announced the completion of a new financing round of approximately RMB 180 million. The round was led by Yicun Capital, with participation from Grand Pharma (a Hong Kong-listed company), Haoyue Capital, and Bank of China International. The proceeds will be primarily used to advance the Phase III clinical trials of its core product, CBT-001, propel four other innovative ophthalmic drug candidates into Phase II clinical trials, and expand the R&D team at its Guangzhou facility.

Linko Pharma Completes Tens of Millions of USD in Series A Financing to Advance IND Applications for Multiple Preclinical Projects

On April 17, 2020, Linko Therapeutics (Hangzhou) Co., Ltd., a new drug development company, announced that it had completed a Series A financing round worth tens of millions of U.S. dollars before the Spring Festival this year. The round was led by Decheng Capital, with participation from Zheshang Innovation Capital, while existing investors Mifang Capital and Cathay Capital continued to participate. The funds raised will primarily be used to advance Investigational New Drug (IND) applications for multiple preclinical projects in Linko Therapeutics’ R&D pipeline, as well as to conduct two to three Phase I clinical trials. Additionally, the company will leverage the raised capital to drive the development of new projects and foster international collaborations.

Moderna Secures $483 Million in Funding to Accelerate COVID-19 Vaccine Development

On April 17, 2020, the U.S. biotechnology company Moderna announced that it had reached an agreement with the Biomedical Advanced Research and Development Authority (BARDA) to receive up to $483 million in funding. This support will be used to facilitate the continued testing and production of the mRNA-1273 vaccine and to help Moderna secure approval from the U.S. Food and Drug Administration (FDA). Moderna stated that it is expanding its manufacturing capacity and can currently supply millions of doses of the mRNA-1273 vaccine per month. If the mRNA-1273 vaccine proves successful in clinical studies and the company secures additional investment, Moderna aims to scale up production to tens of millions of doses per month by 2021.

Novartis’ Secukinumab for Ankylosing Spondylitis Set for Imminent Approval in China

Recently, the marketing application for a new indication of Novartis’s secukinumab (commonly known as “Su Jin Dan Kang”; acceptance number: JXSS1900025) has been updated to “under review,” with approval expected in the near future. Secukinumab was first approved for marketing by China’s National Medical Products Administration (NMPA) in March 2019. This new approval marks its second indication, specifically for ankylosing spondylitis. Secukinumab (brand name: Cosentyx/Ke Shan Ting; commonly known as “Su Jin Dan Kang”) is a fully human IgG1κ monoclonal antibody targeting IL-17A, developed by Novartis.

Fosun Pharma’s Febuxostat Tablets Become the First to Pass Quality and Efficacy Consistency Evaluation, for Long-Term Treatment of Hyperuricemia in Patients with Gout

On April 16, Fosun Pharma announced that its subsidiary, Jiangsu Wanbang Biopharmaceuticals, had received a “Drug Supplemental Application Approval” from the National Medical Products Administration (NMPA) for its febuxostat tablets, making it the first company in China to pass the consistency evaluation for this drug. Febuxostat tablets are primarily used for the long-term treatment of hyperuricemia in patients with gout. Currently, only three companies have obtained approval for generic versions in China: Hengrui Medicine, Wanbang Biopharmaceuticals, and Zhuyangxin Pharmaceutical. The original innovator product, febuxostat tablets (brand name Uloric/Feibuli) manufactured by Japan’s Teijin Limited, was approved for import by the NMPA on September 4, 2018.

Beide Pharmaceutical’s Clarithromycin Tablets Pass the Consistency Evaluation and Are Indicated for Infections Caused by Clarithromycin-Susceptible Bacteria

On April 15, Sunflower announced that its controlled subsidiary, Zhejiang Beide Pharmaceutical Co., Ltd., recently received the "Drug Supplemental Application Approval" for Clarithromycin Tablets issued by the National Medical Products Administration (NMPA). The Clarithromycin Tablets manufactured by Beide Pharmaceutical have passed the consistency evaluation of quality and efficacy for generic drugs. Clarithromycin Tablets are indicated for infections caused by clarithromycin-sensitive organisms, including nasopharyngeal infections, lower respiratory tract infections, skin and soft tissue infections, acute otitis media, Mycoplasma pneumoniae pneumonia, and urethritis and cervicitis caused by Chlamydia trachomatis. They are also used for the treatment of Legionella infections, either as monotherapy or in combination with other drugs for infections caused by Mycobacterium avium complex and Helicobacter pylori.

Wanbang Pharma’s Febuxostat Tablets Pass the Generic Drug Consistency Evaluation

Recently, Jiangsu Wanbang Biopharmaceutical Group Co., Ltd., a controlling subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., received the “Approval for Supplementary Drug Application” issued by the National Medical Products Administration regarding febuxostat tablets (brand name: Uritong®, strengths: 40 mg and 80 mg). The drug has passed the consistency evaluation for generic drugs.

CR Double-Crane Valsartan Capsules Pass the Generic Drug Consistency Evaluation

On April 16, China Resources Double-Crane Pharmaceutical issued an announcement stating that its wholly-owned subsidiary, China Resources Saike Pharmaceutical Co., Ltd., had passed the consistency evaluation for generic drugs for its Valsartan Capsules (80 mg). With this approval, China Resources Double-Crane has entered the domestic valsartan capsule market, which is valued at over RMB 5 billion. Valsartan Capsules are primarily indicated for the treatment of mild to moderate essential hypertension. As a blockbuster angiotensin II receptor antagonist (ARB) antihypertensive agent, it is one of the most widely used antihypertensive medications in the Chinese market.

Borui Pharmaceutical Obtains Drug Registration Approval for Micafungin Sodium for Injection

On April 16, Borui Medicine announced that its wholly-owned subsidiary, Xintai Pharmaceutical, had received the Drug Registration Approval issued by the National Medical Products Administration for “Micafungin Sodium for Injection.” The indications for Micafungin Sodium for Injection are as follows: infections caused by Aspergillus and Candida, including fungemia, respiratory fungal infections, and gastrointestinal fungal infections.

Luye Pharma’s Marketing Application for Bevacizumab Injection, an Anti-Tumor Biologic, Accepted

On April 17, 2020, Luye Pharma Group announced that its marketing application for LY01008 (generic name: Bevacizumab Injection), an anti-tumor biologic, had been accepted by the Center for Drug Evaluation of the National Medical Products Administration of China. LY01008 is a biosimilar to Avastin®, indicated for the treatment of advanced, metastatic, or recurrent non-small cell lung cancer and metastatic colorectal cancer.

Regeneron’s Ebola Drug REGN-EB3 Receives FDA Priority Review

On April 16, Regeneron announced that the U.S. Food and Drug Administration (FDA) had accepted its application and granted priority review for the Ebola drug REGN-EB3. In clinical trials, REGN-EB3 demonstrated superior therapeutic efficacy compared to ZMapp. REGN-EB3 is a cocktail of three monoclonal antibodies and had previously received orphan drug designation and breakthrough therapy designation.

Innovent Biologics’ Tyvyt Granted Third Orphan Drug Designation by FDA for the Treatment of Esophageal Cancer

On April 16, Innovent Biologics announced that the U.S. FDA has granted Orphan Drug Designation to its PD-1 inhibitor Tyvyt® (sintilimab) for the treatment of esophageal cancer. This marks the third Orphan Drug Designation received by Tyvyt®. Previously, it had been granted an orphan designation by the European Medicines Agency (EMA) for peripheral T-cell lymphoma and by the FDA for T-cell lymphoma.

Alphamab Oncology’s Bispecific Antibody KN046 Receives FDA Approval for Phase II Clinical Trial

On April 16, 2020, Alphamab Oncology announced that the U.S. Food and Drug Administration (FDA) had approved the Investigational New Drug (IND) application for KN046, a recombinant humanized PD-L1/CTLA-4 bispecific antibody developed by its wholly-owned subsidiary, Jiangsu Alphamab Bio-Pharmaceuticals Co., Ltd. This approval will enable the initiation of a Phase II clinical study to treat PD-(L)1-refractory or recurrent non-small cell lung cancer (NSCLC). KN046 has demonstrated favorable safety profiles and preliminary efficacy in concurrent Phase I clinical trials conducted in Australia and China, as well as in multiple Phase II trials carried out in China. Following this FDA approval, KN046 will proceed directly to Phase II clinical trials in the United States.

BeiGene to Launch Clinical Trial of BTK Inhibitor Zanubrutinib in Patients with Severe COVID-19

On April 17, 2020, industry news emerged that BeiGene was conducting a clinical trial of its drug Brukinsa (zanubrutinib) in patients with severe COVID-19 in the United States. According to Forbes, BeiGene has submitted an application for a Phase 2 randomized trial to the U.S. FDA, planning to enroll 42 American patients, with results expected within two to three months. Zanubrutinib is an orally administered small-molecule BTK inhibitor independently developed by BeiGene. It is characterized by maximizing specific binding to the BTK target, thereby minimizing toxic side effects caused by off-target effects.

IVI, INOVIO, and KNIH to Partner with CEPI on Phase 1/2 Clinical Trial of INOVIO’s COVID-19 Vaccine Candidate in South Korea

On April 16, the International Vaccine Institute (IVI) announced that the Coalition for Epidemic Preparedness Innovations (CEPI) has provided a $6.9 million grant to INOVIO to support Phase 1/2 clinical trials of its COVID-19 vaccine candidate (INO-4800) in South Korea, conducted in collaboration with IVI and the Korea National Institute of Health (KNIH). These trials will be carried out concurrently with INOVIO’s Phase 1 study of INO-4800, which commenced in the United States on April 6, 2020, initially enrolling 40 healthy adults and later expanding to include older adults.

Sinovac Biotech’s Inactivated COVID-19 Vaccine Initiates Phase I Clinical Trial; First Batch of Volunteers Vaccinated

On April 16, Sinovac Biotech Ltd. announced that the Phase I clinical trial of CoronaVac™, the inactivated COVID-19 vaccine developed by its subsidiary Beijing Sinovac Life Sciences Co., Ltd., was officially launched in Suining County, Xuzhou City, Jiangsu Province. The first batch of volunteers has been successfully enrolled and received their first dose. According to the announcement, this randomized, double-blind, placebo-controlled (using a control vaccine without viral components) Phase I clinical trial is being conducted under the auspices of the Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Institute of Public Health). The study aims to evaluate the safety, tolerability, and preliminary immunogenicity of different doses of the inactivated COVID-19 vaccine in healthy volunteers. A total of 144 healthy volunteers aged 18 to 59 years were recruited for the first stage.

Novartis Releases Positive Long-Term Real-World Data on Aimovig for the Preventive Treatment of Migraine

On April 16, Novartis released the latest clinical data on Aimovig (erenumab) for the preventive treatment of migraine, confirming its real-world and long-term safety and therapeutic benefits for patients with episodic and chronic migraine. The newly disclosed real-world evidence includes interim exploratory results from the TELESCOPE study, which showed that 80% of patients treated with Aimovig reported reduced migraine intensity, 92% experienced a reduction in attack frequency, with an average decrease of 8 monthly migraine days (MMD). Another set of interim results came from the PERISCOPE study, involving 19,740 migraine patients, including 91 patients with an overall mean disease duration of up to 18 years. The results demonstrated that 85% of patients treated with Aimovig achieved better management of daily activities.

Zai Lab’s Supplemental New Drug Application for Niraparib Granted Priority Review Status

On April 17, Zai Lab announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) had granted priority review status to the supplemental new drug application for Zejula® (niraparib) for the maintenance treatment of adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved a complete or partial response to first-line platinum-based chemotherapy.

Latest Clinical Trial Update on Remdesivir: Most COVID-19 Patients Discharged Within a Week

On April 17, the medical media outlet Stat News reported that partial clinical data on Gilead Sciences’ remdesivir for the treatment of COVID-19 patients were prematurely disclosed at an internal meeting at the University of Chicago Medical Center. The report indicated that among 125 COVID-19 patients who received remdesivir, most experienced rapid resolution of fever and respiratory symptoms and were discharged after one week of treatment. Of these, 113 enrolled patients had severe disease, and two died. Gilead has since confirmed the authenticity of the report, stating, “These are the study results we have been anticipating.”

Innovent Biologics’ IBI362 for Injection Approved for Clinical Trials, with Indications for Weight Loss and Type 2 Diabetes

On April 16, the CDE website showed that Innovent Biologics’ IBI362 for injection received implicit clinical trial approval, with indications for weight loss and type 2 diabetes. IBI362 (OXM3) is a dual agonist of the glucagon-like peptide-1 (GLP-1) receptor and the glucagon receptor, developed by Eli Lilly; on August 23, 2019, Innovent and Eli Lilly reached a strategic collaboration agreement to jointly advance the development and commercialization of OXM3 in China.

CartiMed and Shenghe Pharma Sign Strategic Partnership to Advance Development of Novel CAR-T Products

Recently, Nanjing Kati Medical Technology Co., Ltd. and Nanjing Sanhome Pharmaceutical Co., Ltd. signed a strategic cooperation agreement on the research and development of novel CAR-T products. Through its preliminary efforts, Sanhome Pharmaceutical has developed several outstanding humanized monoclonal antibody products. The company aims to expand its product portfolio into the field of cell therapy through collaboration with Kati Medical. This partnership will also enable Kati Medical to diversify its product offerings and accelerate the advancement of its pipeline. The first step in this strategic collaboration is the joint development of a CAR-T product incorporating a specific humanized antibody. This product, built on Kati Medical’s new CAR technology platform, targets several high-incidence solid tumors.

Pharmaceutical Company Soligenix and Boston Scientific Sign Exclusive Global Licensing Agreement for CoVaccine HT COVID-19 Vaccine Adjuvant

Recently, biopharmaceutical company Soligenix announced that it has entered into an exclusive global licensing agreement with Boston Scientific for CoVaccine HT, a novel adjuvant for COVID-19 vaccines. CoVaccine HT, from Boston Scientific’s BTG Specialty Pharmaceuticals division, is now licensed to Soligenix for use against SARS-CoV-2. The terms of the transaction were not disclosed.

JW Therapeutics Plans Overseas Listing to Raise Up to $300 Million, with Investors Including Sequoia China

On April 17, 2020, according to IPO Early Know, Shanghai WuXi Juno Biologics Co., Ltd., an innovative biopharmaceutical R&D company, plans to complete its overseas listing this year, with an expected fundraising scale of USD 200–300 million. However, it has not yet determined whether to list on the Hong Kong Stock Exchange or in the United States. WuXi Juno’s core business focuses on the research, translation, and application of cellular immunotherapy. The company has obtained China’s first Investigational New Drug (IND) approval for a CD19-targeted CAR-T cell therapy product, covering four indications in Phase I and Phase II clinical trials.

Biotech Company Provention Submits Teplizumab Biologics License Application to FDA on a Rolling Basis

On April 16, biotechnology company Provention Bio announced that it had initiated a rolling submission of the Biologics License Application (BLA) for teplizumab (PRV-031) to the U.S. Food and Drug Administration (FDA). Teplizumab is an anti-CD3 monoclonal antibody indicated for delaying or preventing type 1 diabetes (T1D) in high-risk populations. Provention has submitted the nonclinical module and plans to submit the clinical module in the third quarter and the Chemistry, Manufacturing, and Controls (CMC) module in the fourth quarter.

Immunotherapy Company PDS Delays Launch of Multicenter Phase 2 VERSATILE-002 Trial for Anti-Cancer Drug PDS0101

On April 16, immunotherapy company PDS Biotechnology announced an expanded infectious disease pandemic development plan, which includes the previously announced tuberculosis program developed in collaboration with Farmacore Biotechnology, as well as novel vaccines targeting COVID-19 and universal influenza. The company also announced that the launch of its multicenter Phase 2 VERSATILE-002 trial of PDS0101 for advanced/metastatic head and neck cancer has been delayed due to the severe adverse impact of the COVID-19 pandemic on clinical trial operations.

《bioRxiv》: Chinese Scientists Reveal the Structural Basis of Remdesivir Inhibiting SARS-CoV-2

Recently, researchers from the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, Zhejiang University School of Medicine, Tsinghua University, and other institutions published peer-review-free findings on the preprint platform bioRxiv. They revealed the structure of SARS-CoV-2 RdRp in its apo form and the structure of the complex formed by SARS-CoV-2 RdRp and a 50-nucleotide template-primer RNA at a resolution of 2.5–2.8 Å. The researchers found that the structure of the complex formed by SARS-CoV-2 RdRp and the 50-nucleotide template-primer RNA indicates that part of the double-stranded RNA template is inserted into the central channel of RdRp, where remdesivir is incorporated at the first replicated base pair, thereby terminating chain elongation.

BBRC: Specific cytokines may help package the influenza virus genome

Recently, a research report published in the international journal Biochemical and Biophysical Research Communications described how researchers used recombinant proteins and mass spectrometry to analyze the characteristics of the interaction between viral nucleoprotein and UAP56. They found that UAP56 highlights two binding sites on the nucleoprotein, one of which was previously unknown. This site is an extension at the N-terminus of UAP56 and can recognize the RNA-binding region of the viral nucleoprotein. The researchers stated that this study reveals how UAP56 acts on RNA-free viral nucleoproteins, and the findings may help to further analyze the mechanism of influenza virus genome packaging mediated by viral nucleoproteins.

《Genes & Dev》: Unveiling the Molecular Mechanism by Which Damaged Fertilized Eggs Send Signals to Help Mothers Maintain Health and Longevity

Recently, a research report published in the international journal Genes & Development revealed that scientists from Northwestern University and other institutions have found that communication between the embryo and the mother may regulate protein homeostasis, stress resistance, and the healthspan of the maternal organism. In other words, unhealthy offspring can promote the mother’s healthspan by inhibiting protein damage processes associated with proteins that drive the onset of human neurodegenerative diseases. This finding may hold significant implications for future research on healthy aging, stress resilience, and the suppression of protein damage in the body.

《Cell》: Caspase-6 May Aid in the Treatment of Viral Diseases Such as Influenza and Certain Inflammatory Disorders

On April 15, scientists at St. Jude Children’s Research Hospital published a study in Cell elucidating the function of the caspase-6 enzyme. The findings indicate that caspase-6 is a key regulator of innate immunity, inflammasome activation, and host defense. Modulating caspase-6 may aid in the treatment of viral diseases such as influenza, as well as other inflammatory conditions, including cancer.

《Diabetologia》: Obesity is a high-risk factor for type 2 diabetes, independent of genetic background

Recently, according to a study published in the journal *Diabetologia*, obesity increases the risk of developing type 2 diabetes by at least sixfold, regardless of genetic predisposition. The study results show that, compared with individuals of normal weight, those with obesity are nearly six times more likely to develop type 2 diabetes, while those who are overweight have a 2.4-fold increased risk. In terms of genetic risk, individuals with the highest genetic risk score (GRS) are twice as likely to develop type 2 diabetes as those with the lowest GRS. Furthermore, individuals with unhealthy lifestyles have an 18% higher likelihood of developing type 2 diabetes compared to those with the healthiest lifestyles.