Nanxin Pharma Surges 86% on STAR Market Debut; Gilead Requests Withdrawal of Remdesivir's Orphan Drug Designation

PerkinElmer Novel Coronavirus Nucleic Acid Detection Kit Receives FDA Emergency Use Authorization

On March 24, PerkinElmer, the world’s largest manufacturer of analytical instruments, announced that the U.S. Food and Drug Administration (FDA) had granted Emergency Use Authorization (EUA) for its novel coronavirus nucleic acid test kit (RT-PCR). Meanwhile, PerkinElmer also announced that this novel coronavirus nucleic acid test kit, as an in vitro diagnostic (IVD) device, complies with the requirements of the European Union’s In Vitro Diagnostic Medical Devices Directive (IVDD) and can be marketed in more than 30 countries and regions across Europe.

Biotech Firm Vir Biotechnology Announces That Its Virus-Neutralizing Antibody Is Poised to Initiate Clinical Trials This Summer

On March 26, 2020, biotechnology company Vir Biotechnology announced that it had identified multiple monoclonal antibodies capable of neutralizing the novel coronavirus, with human clinical trials expected to commence within three to five months. These candidate antibodies not only hold promise as therapeutic options for COVID-19 but may also provide prophylactic effects against infection. To accelerate development, Vir had previously entered into collaboration agreements with WuXi Biologics and Biogen for several of these candidate antibodies.

Emergency Use Authorization May Further Accelerate Moderna’s COVID-19 Vaccine Development Process

Recently, Moderna stated in a regulatory filing (Form 8-K) that the Phase 1 clinical trial of its COVID-19 vaccine candidate, mRNA-1273, is currently proceeding smoothly. Although it may take 12–18 months to complete the development and manufacturing processes for a commercially viable vaccine available at scale, Moderna noted that if relevant regulatory agencies grant an Emergency Use Authorization (EUA) for this therapy, it could potentially be used as early as this fall in certain populations, such as frontline healthcare workers. This development timeline hinges on the positive performance of mRNA-1273 in clinical trials and regulatory authorization. Currently, the company is expanding its production capacity, aiming to achieve a monthly output of millions of vaccine doses.

FDA Authorizes Emergency Use of Convalescent Plasma Therapy for Critically Ill COVID-19 Patients

On March 24, under the latest emergency treatment protocol approved by the U.S. Food and Drug Administration (FDA), physicians across the United States will be permitted to begin using plasma donated by individuals who have recovered from COVID-19 to treat critically ill patients. Data from China indicate that a single plasma donation can save the lives of two to three COVID-19 patients. Additionally, some studies suggest that transfusing plasma into healthy individuals may confer a certain degree of preventive benefit; however, the FDA has explicitly prohibited its use for any prophylactic purpose. As this therapy has not yet undergone clinical validation, the FDA has approved its use solely in emergency situations where patients’ lives are under serious threat.

《bioRxiv》: Scientists Use CRISPR to Cleave the SARS-CoV-2 Genome for COVID-19 Treatment

Recently, researchers from Stanford University’s Department of Bioengineering and other institutions developed a CRISPR-Cas13-based strategy called PAC-MAN (Prophylactic Antiviral CRISPR in huMAN cells) to effectively degrade SARS-CoV-2 sequences and live influenza A virus (IAV) genomes in human lung epithelial cells, thereby achieving potent viral suppression. The researchers stated that this PAC-MAN approach could serve as a rapidly deployable pan-coronavirus suppression strategy, helping to effectively combat emerging pandemic strains.

Fosun Pharma’s COVID-19 Nucleic Acid Test Kit Receives Emergency Approval from the National Medical Products Administration

On March 26, Fosun Pharma announced that the novel coronavirus nucleic acid detection kit developed by its wholly-owned subsidiary, Fosun Diagnostics, had passed the emergency review of the National Medical Products Administration (NMPA) and obtained a Medical Device Registration Certificate (Registration No.: Guo Xie Zhu Zhun 20203400299). The product can complete full testing of 96 samples within two hours. Automated testing reduces the risk of infection for operators and the risk of cross-contamination in laboratories, thereby improving testing efficiency. Additionally, on March 17, the nucleic acid detection reagent independently developed by Fosun Diagnostics received CE certification from the European Union, meeting the market access requirements for the EU.

Nanxin Pharmaceutical Lists on the STAR Market, Raising 1.223 Billion Yuan

On March 26, Hunan Nanxin Pharmaceutical Co., Ltd. was officially listed on the STAR Market, with an issue price of RMB 34.94 per share, a total issuance of 35 million shares, and proceeds amounting to RMB 1.223 billion. Nanxin Pharmaceutical plans to allocate 34% (RMB 409 million) of the IPO proceeds to innovative drug research and development, including RMB 177 million for the follow-up development of metrafenib, RMB 133 million for the follow-up development of meflufenidone hydrochloride, and RMB 100 million for the R&D of two improved new drug projects based on peramivir.

WuXi AppTec Plans Private Placement to Raise No More than RMB 6.528 Billion

On March 25, WuXi AppTec released its 2020 plan for the non-public issuance of A-shares. The number of A-shares to be issued in this non-public offering shall not exceed 75 million shares, with total proceeds not exceeding RMB 6.528 billion. After deducting relevant issuance expenses, the net proceeds will be invested in the following projects: “Phase I Project of New Drug Formulation Development Services and Formulation Production by WuXi STA (Wuxi),” “Global R&D Center and Supporting Facilities Project of WuXi STA,” “New Drug Production and R&D Center Project of WuXi STA (Changzhou),” “Integrated New Drug Production and R&D Project of WuXi STA (Changzhou),” “Project for Upgrading Technological Capabilities of Small-Molecule Innovative Drug Manufacturing Process Platform at WuXi STA,” “Project for Upgrading Technological Capabilities of Drug R&D Platform at WuXi AppTec (Shanghai),” and “Supplementing Working Capital.”

Merck’s MET Inhibitor Tepmetko Receives First Global Approval for First-Line Treatment of Patients with Specific Lung Cancer

On March 25, Merck announced that Japan’s Ministry of Health, Labour and Welfare had approved the marketing of Tepmetko (tepotinib) for the treatment of patients with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. This marks the first orally administered MET inhibitor approved for market launch worldwide. Tepotinib is an oral MET inhibitor designed to suppress MET receptor signaling triggered by MET gene alterations, including MET exon 14 skipping mutations, MET amplification, or MET protein overexpression.

Johnson & Johnson’s Stelara® (Stelara) Approved in Japan for New Indication: Treatment of Ulcerative Colitis

Recently, Tanabe Mitsubishi Pharma announced that Janssen Pharmaceutical K.K., a subsidiary of Johnson & Johnson’s Janssen division in Japan, has received partial approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for changes to the manufacturing and marketing authorization application for the anti-inflammatory drug Stelara® (Chinese brand name: Xidano®; generic name: ustekinumab). The approved scope includes the intravenous infusion formulation (for induction therapy in adult patients with moderately to severely active ulcerative colitis [UC] who have had an inadequate response or intolerance to conventional therapy or biologics) and the subcutaneous injection formulation (for maintenance therapy in adult patients with moderately to severely active ulcerative colitis [UC] who have had an inadequate response or intolerance to conventional therapy or biologics).

Daiichi Sankyo’s Antibody-Drug Conjugate Enhertu Approved in Japan for the Treatment of Patients with HER2-Positive Breast Cancer

Recently, Daiichi Sankyo announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Enhertu (trastuzumab deruxtecan, DS-8201) for the treatment of patients with HER2-positive, unresectable or metastatic breast cancer who have relapsed after prior chemotherapy (limited to patients who are refractory to or intolerant of standard therapy). In the United States, Enhertu received accelerated approval in December 2019 for adult patients with HER2-positive metastatic breast cancer who have previously received two or more anti-HER2-based regimens in the metastatic setting.

Takeda’s Targeted Anti-Cancer Drug Cabometyx Approved in Japan for the Treatment of Unresectable and Metastatic Renal Cell Carcinoma

Recently, Exelixis announced that its Japanese partner, Takeda Pharmaceutical Company Limited, has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to manufacture and market the targeted anticancer drug Cabometyx (cabozantinib) for the treatment of patients with unresectable and metastatic renal cell carcinoma (RCC). Under the collaboration and license agreement between the two parties, Exelixis is eligible to receive a $31 million milestone payment upon Takeda’s first commercial sale of Cabometyx for the treatment of unresectable or metastatic RCC.

Baiyunshan Subsidiary Receives "Drug Re-registration Approval" for 22 Drugs, Including Akafen Powder

On March 25, Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd. announced that its branch factories, including Baiyunshan General Pharmaceutical Factory and Hejigong Pharmaceutical Factory, as well as its controlled subsidiary Xingqun Pharmaceutical and wholly-owned subsidiary Qixing Pharmaceutical, had recently received the Drug Re-registration Approval issued by the Guangdong Provincial Medical Products Administration for 22 drugs, including APC Powder and Acetohydroxamic Acid Capsules.

Longshen Rongfa Xiaoshuan Tongluo Tablets (for Stroke Treatment) Approved for Registration in Singapore

On March 25, Longshen Rongfa announced that its wholly-owned subsidiary, Gansu New Silk Road Industrial Investment Co., Ltd., had received notification that the company’s drug, Xiaoshuan Tongluo Tablets, had obtained registration and filing approval from the Republic of Singapore. This approval permits the formal export and sale of Xiaoshuan Tongluo Tablets in the Republic of Singapore. The primary functions of Xiaoshuan Tongluo Tablets are to promote blood circulation, remove blood stasis, warm the meridians, and unblock collaterals. They are indicated for hemiplegia and limb numbness during the recovery phase (within one year) of stroke (cerebral thrombosis).

Bayer’s Eylea Approved in Japan for Fifth Indication: Treatment of Neovascular Glaucoma

Recently, Bayer Yakuhin, a Japanese subsidiary of Bayer, and Santen Pharmaceutical jointly announced that Eylea (aflibercept) has been approved in Japan for a new indication: the treatment of neovascular glaucoma (NVG). This approval covers both the vial formulation and the pre-filled syringe of Eylea. Eylea is the first drug globally approved for the treatment of NVG and had previously been granted orphan drug designation for this indication.

Sumitomo Pharma’s Latuda Approved in Japan for Schizophrenia and Bipolar Depression

On March 25, Sumitomo Dainippon Pharma announced that its atypical antipsychotic drug Latuda® (lurasidone HCl; lurasidone hydrochloride tablets; Chinese brand name: Luoshuda®) had been approved in Japan for the treatment of schizophrenia and bipolar depression. The press release stated that Sumitomo Dainippon Pharma submitted a new drug application to Japanese regulatory authorities on July 31, 2019, seeking approval of Latuda for schizophrenia and bipolar depression. This application was based on data from a Phase III study in patients with schizophrenia (the JEWEL study) and a Phase III study in patients with bipolar I depression (the ELEVATE study).

Jianyou Shares’ Bortezomib for Injection Receives Provisional FDA Approval for the Treatment of Multiple Myeloma and Mantle Cell Lymphoma

On March 25, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (King-Friend Shares) announced that its subsidiary, Hong Kong King-Friend, recently received notification from the U.S. Food and Drug Administration (FDA) that its Abbreviated New Drug Application (ANDA) for Bortezomib for Injection had been granted tentative approval. The U.S. patent for this product expired on July 25, 2022. Bortezomib is a dipeptide boronate analog and the world’s first synthetically produced novel competitive proteasome inhibitor used in clinical practice, indicated for the treatment of multiple myeloma and mantle cell lymphoma. To date, King-Friend Shares has invested approximately RMB 6.0671 million in research and development for Bortezomib for Injection.

AstraZeneca and Daiichi Sankyo’s Antibody-Drug Conjugate Enhertu Yields Positive Data in Non-Small Cell Lung Cancer Trial

On March 26, 2020, Enhertu (fam-trastuzumab deruxtecan-nxki, DS-8201), a HER2-targeting antibody-drug conjugate (ADC) co-developed by Daiichi Sankyo and AstraZeneca, reduced tumor size in 55.6% of patients with non-small cell lung cancer (NSCLC) in a Phase I clinical trial involving patients with previously treated HER2-overexpressing cancers.

Jazz Pharmaceuticals’ New Drug Application for Investigational Antioxidant JZP-258 Accepted by FDA for the Treatment of Narcolepsy

On March 25, biopharmaceutical company Jazz Pharmaceuticals announced that the U.S. FDA had accepted its New Drug Application (NDA) for JZP-258 for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients aged 7 years and older with narcolepsy, and would conduct a priority review. The PDUFA target date is July 21, 2020. JZP-258 is a novel oxybate candidate drug with a unique cationic composition.

MD Anderson Cancer Center Researchers Announce Results of First U.S. CAR-NK Cell Clinical Trial

Recently, researchers from institutions including The University of Texas MD Anderson Cancer Center announced the results of the first U.S. clinical trial of CAR-NK cells (NCT03056339). The study showed that most patients with relapsed or refractory non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL), who had previously undergone extensive treatment, achieved clinical responses after receiving umbilical cord blood-derived CAR-NK therapy, without significant toxicity.

Novartis’ Gene Therapy Zolgensma Demonstrates Robust Efficacy in Treating Type 2 SMA Patients via Intrathecal Injection

Recently, AveXis, a gene therapy company under Novartis, announced the latest data from the Phase I/II STRONG study evaluating intrathecal administration of the one-time gene therapy Zolgensma (onasemnogene abeparvovec, AVXS-101) in patients with type 2 spinal muscular atrophy (SMA). The results showed that pediatric patients with type 2 SMA (aged ≥2 to <5 years) who received a single intrathecal injection of Zolgensma at Dose B (1.2 × 10^14 vg) met the primary efficacy endpoint. Zolgensma is a one-time gene therapy designed to address the genetic root cause of SMA by replacing the function of the missing or nonfunctional SMN1 gene.

Innovent Biologics and Alector Partner to Develop and Commercialize Anti-SIRP-alpha Antibody in China

On March 26, 2020, Innovent Biologics and Alector, a clinical-stage biotechnology company, announced a collaboration under which Innovent Biologics obtained the rights to develop and commercialize AL008, Alector’s novel anti-SIRP-alpha antibody for the treatment of cancer (Alector development code: AL008), in China (including Hong Kong, Macao, and Taiwan). Under the terms of the agreement, Innovent Biologics will lead the development and commercialization of AL008 in China, including manufacturing, while Alector will lead the development of AL008 outside of China. Specific financial terms were not disclosed.

AstraZeneca Partners with Silence Therapeutics to Develop siRNA Therapies for Cardiovascular, Renal, Metabolic, and Respiratory Diseases

Recently, AstraZeneca announced a collaboration with Silence Therapeutics to discover, develop, and commercialize small interfering RNA (siRNA) therapies for the treatment of cardiovascular, renal, metabolic, and respiratory diseases. This multi-target partnership will leverage Silence’s siRNA platform to identify and develop liver-based targets, as well as to create novel delivery methods for targeting other tissues, including the heart, lungs, and kidneys.

Red Sun Plans to Acquire Controlling Stake in Kunning Biology with RMB 26.39 Million Capital Injection

Recently, Red Sun announced its plan to invest RMB 26.39 million from its own funds to acquire a controlling stake in Kunning Biology. Following the capital increase, Kunning Biology’s registered capital will rise to RMB 30.3 million, with Red Sun holding RMB 20.3 million of the registered capital, accounting for a 67% equity interest. The newly injected funds will be entirely allocated to preclinical research and clinical trials of a specific antidote for paraquat poisoning.

Molecular Diagnostics Company QIAGEN Appoints Thierry Bernard as CEO

On March 25, molecular diagnostics company QIAGEN announced the appointment of Thierry Bernard as Chief Executive Officer. On October 7, 2019, Peer M. Schatz, former CEO of QIAGEN, decided to resign from his positions as Chief Executive Officer and Chairman of the Management Board. At that time, Thierry Bernard, then Senior Vice President and Head of the Molecular Diagnostics business area, served as Interim CEO in collaboration with Chief Financial Officer Roland Saks.

Gilead Announces Request to Withdraw Orphan Drug Designation for Remdesivir

On March 26, 2020, Gilead Sciences issued a statement announcing that it had requested the U.S. Food and Drug Administration (FDA) to revoke the orphan drug designation granted to remdesivir and to waive all benefits associated with such designation. These benefits include the exemption from submitting a Pediatric Study Plan prior to the New Drug Application, a review process that can take up to 210 days. Gilead stated that the regulatory review of remdesivir would be expedited even without the orphan drug designation.

BeiGene Releases Update on the Supply Status of ABRAXANE® (Paclitaxel for Injection, Albumin-Bound) in China

On March 26, 2020, BeiGene issued an announcement stating that the National Medical Products Administration (NMPA) had announced on March 25, 2020, its decision to suspend the import, sale, and use of Celgene’s (now part of Bristol Myers Squibb) ABRAXANE® (paclitaxel protein-bound particles) for injectable suspension in China. This decision was based on inspection findings at a contract manufacturing organization located in the United States and affiliated with Bristol Myers Squibb. BeiGene anticipates that this will result in a temporary disruption of ABRAXANE® supply in China. The Company is working closely with Bristol Myers Squibb to restore supply as soon as possible, including Bristol Myers Squibb’s corrective actions at the existing manufacturing site and its submission of an application to utilize another manufacturing facility to supply the Chinese market.

Digital Cell Biology Company Berkeley Lights Establishes Global Alliance for Emerging Pathogen Antibody Discovery

On March 26, 2020, Berkeley Lights, a digital cell biology company, announced the establishment of the Global Emerging Pathogen Antibody Discovery (GEPAD) Alliance. Founding members of the alliance include Dr. James Crowe and Dr. Robert Carnahan from Vanderbilt University Medical Center. The alliance was formed with the goal of accelerating the discovery of neutralizing antibodies from patient blood samples. Leveraging Berkeley Lights’ Beacon platform, the alliance will use blood samples from recovered patients as a therapeutic basis for antibody discovery, with SARS-CoV-2 as its initial therapeutic target.

Salubris’ Recombinant Teriparatide for Injection Hits the Market, with a Retail Price of 960 Yuan per Box

Recently, Salubris’s recombinant teriparatide for injection (brand name: Xinfutai) has launched on the market, with a retail price of RMB 960 per box (10 vials per box, 200 IU/20 μg per vial). At a dosage of one vial per day, the annual treatment cost is approximately RMB 35,000. Teriparatide for injection (lyophilized powder for injection of recombinant human parathyroid hormone 1-34 [rhPTH1-34]) is a blockbuster drug in the field of osteoporosis treatment developed by Eli Lilly and Company, marketed under the brand name Forteo. It is currently the only FDA-approved medication that promotes bone formation.

Science Advances: Zhejiang University Team Successfully Develops “Universal Panda Blood” for Emergency Transfusion Without Matching

Recently, a joint research team led by Professor Tang Ruikang from the Department of Chemistry at Zhejiang University and Associate Professor Wang Ben from the Institute of Translational Medicine at Zhejiang University successfully developed “universal panda blood.” By constructing a gel network of polysialic acid–tyramine hydrochloride on the surface of red blood cells using cell membrane-anchoring molecules, this method enables the batch conversion of readily available RhD-positive red blood cells into RhD-negative ones. This allows for emergency transfusions without the need for RhD blood type matching and without triggering rejection reactions. This approach holds promise for efficiently addressing the shortage of “panda blood” donors. The related findings have been published in the international journal *Science Advances*.

Annals of Internal Medicine: Study Finds Interleukin-1β Inhibition Associated with Reduced Incidence of Anemia

On March 24, a study published online in the journal *Annals of Internal Medicine* found that inhibition of interleukin-1β (IL-1β) by the monoclonal antibody canakinumab reduces the incidence of anemia and improves hemoglobin levels in patients with anemia. In this study, Mounica Vallurupalli, MD, and colleagues from Brigham and Women’s Hospital in Boston conducted an exploratory analysis of a multicenter randomized controlled trial. The study included 8,683 participants who developed anemia following antithrombotic therapy, as well as 1,303 participants who developed anemia after treatment.

《Nature》: Scientists Map the World’s First Human Cell Atlas

Recently, the world’s first human cell atlas was successfully constructed at Zhejiang University. The research team performed Microwell-seq-based high-throughput single-cell sequencing analysis on 60 types of human tissue samples and seven types of cell culture samples, systematically generating a human cell atlas that spans both embryonic and adult stages and covers eight major physiological systems. This study provides the first comprehensive analysis of human cell types at the single-cell level across embryonic and adult periods. The resulting dataset will serve as a resource for exploring the mechanisms governing cell fate determination, and the methodology employed is expected to influence the identification of cellular states in both health and disease. These findings were published online in Nature.

Nature Communications: Study Confirms Close Link Between Infant Immunity and Maternal Gut Microbiota

On March 24, a health study published in the journal Nature Communications confirmed that the risk of allergies in infants after birth is closely related to the maternal gut microbiota—specifically, the presence of Prevotella copri in the gut microbiota of pregnant women reduces the risk of food allergies in infants during their first year of life.

Nature: Stanford University Team Leverages AI Technology for Non-Invasive Early Lung Cancer Screening

On March 26, 2020, a study published in Nature reported that researchers at Stanford University had developed a machine learning method capable of differentiating and screening for early-stage lung cancer. This approach is based on the detection of tumor-derived DNA in blood samples (i.e., liquid biopsy), thereby enabling early, non-invasive screening for individuals at high risk of lung cancer.