APTBIO Completes Nearly RMB 200 Million Series A Financing to Advance Mass Spectrometry Platform and Precision Medicine Development

APTBio Completes Nearly RMB 200 Million in Series A Financing to Support the Construction of Its Mass Spectrometry Platform Capacity Center and Other Initiatives

On April 22, Shanghai Zhongke New Life Biotechnology Co., Ltd. announced the completion of its Series A financing round, raising nearly RMB 200 million. The round was led by Luxin Venture Capital and Wuxi Financial Investment Group, with participation from Guangzhou Qudao Asset Management and other investors. The funds raised will be primarily used to expand the company’s mass spectrometry platform production center and high-performance computing center, develop precision medicine products, and expand into domestic and international markets, thereby further enhancing its R&D and commercial operational capabilities.

Astellas Acquires Unique Screening Platform Nanna to Boost Drug Development for Mitochondrial Diseases

On April 21 (local time), Astellas announced that it had acquired the UK-based biotechnology company Nanna Therapeutics Limited (“Nanna”), with plans to apply Nanna’s advanced compound screening technology to the early-stage drug development for mitochondrial-related diseases. Reportedly, the acquisition was executed through Astellas’ UK subsidiary, which purchased all of Nanna’s issued share capital. Astellas paid an acquisition consideration of £12 million, and Nanna’s shareholders are also eligible to receive potential R&D milestone payments of up to £57.5 million in the future.

Tremfya (Guselkumab), Janssen’s Targeted Interleukin-23 Inhibitor, Launches in China

Recently, Janssen Pharmaceutical Companies of Johnson & Johnson’s subsidiary in China, Xian Janssen Pharmaceutical Ltd., announced that its product TREMFYA® (guselkumab injection; international brand name: TREMFYA®) has been launched in China for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. TREMFYA® is the world’s first approved interleukin-23 (IL-23) inhibitor, which selectively targets and inhibits IL-23, a key cytokine involved in the pathogenesis of psoriasis.

Jianmin Group’s Anti-Epileptic Drug Levetiracetam Oral Solution Approved

On April 21, Jianmin Group announced that its wholly-owned subsidiary, Jianmin Group Yekaitai Pharmaceutical (Suizhou) Co., Ltd., had received the Drug Registration Approval issued by the National Medical Products Administration for Levetiracetam Oral Solution. Levetiracetam Oral Solution is indicated as adjunctive therapy for partial-onset seizures in adult, pediatric, and infant patients aged one month and older with epilepsy.

CR Double-Crane Launches Feitong, a Pediatric Primary Respiratory Drug

On April 22, China Resources Double-Crane held the national launch conference for Feitong® via cloud live streaming, attracting nearly 30,000 online viewers. This launch marks the addition of another blockbuster product to China Resources Double-Crane’s pediatric portfolio. Caffeine Citrate Injection is a medication recommended by multiple authoritative guidelines for the treatment of primary apnea in premature neonates; it is listed as a Class B drug under the National Reimbursement Drug List and included in the National Essential Medicines List (2018 Edition). Feitong® is currently the only Caffeine Citrate Injection in China that has passed the Consistency Evaluation of Generic Drugs.

Qianjin Pharmaceutical’s Controlled Subsidiary’s Valsartan Capsules Pass the Consistency Evaluation

On April 21, Qianjin Pharmaceutical announced that its controlled subsidiary, Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd., had received the "Approval for Supplemental Drug Application" issued by the National Medical Products Administration (NMPA) for Valsartan Capsules. The drug has passed the consistency evaluation of quality and efficacy for generic drugs. Valsartan Capsules are a specific angiotensin II receptor antagonist used to treat mild to moderate primary hypertension.

Yiming Pharmaceutical’s Miglitol Tablets for Diabetes Become the First to Pass Consistency Evaluation

On April 22, Vio Pharmaceuticals, a wholly-owned subsidiary of Yiming Pharmaceutical, received the "Drug Supplementary Application Approval" for the chemical drug "Miglitol Tablets (50mg)" issued by the National Medical Products Administration (NMPA), thereby passing the consistency evaluation of quality and efficacy for generic drugs of this product. Vio Pharmaceuticals is the drafting entity for the quality standards of Miglitol Tablets. Miglitol Tablets are indicated, in conjunction with dietary control and exercise, for improving glycemic control in adults with type 2 diabetes mellitus. In patients with diabetes, miglitol delays glucose absorption by inhibiting α-glucosidase, thereby reducing postprandial hyperglycemia and flattening peak blood glucose levels.

Taiji Group’s Antidepressant Citalopram Hydrobromide Passes Consistency Evaluation

On April 21, Taiji Group announced that its controlled subsidiary, Southwest Pharmaceutical, had received the “Approval for Supplementary Application” from the National Medical Products Administration (NMPA) for Citalopram Hydrobromide Tablets, indicating that the drug has passed the generic drug consistency evaluation. Citalopram Hydrobromide Tablets are listed as a Category B drug in the “National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance (2019 Edition).” The indication for Citalopram Hydrobromide Tablets is the treatment of depression.

AbbVie’s Imbruvica Receives FDA Approval for 11th Indication: Treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL)

On April 21, AbbVie announced that the U.S. Food and Drug Administration (FDA) had approved Imbruvica (ibrutinib) in combination with rituximab as a first-line treatment for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). This marks the 11th indication for Imbruvica since its market launch in 2013, and the sixth approval specifically for CLL indications.

EMA Revokes Authorization for LEO Pharma’s Actinic Keratosis Drug Picato Over Cancer Risk

Recently, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) issued an announcement confirming that Picato (ingenol mebutate), a topical gel product from LEO Pharma of Denmark used for treating actinic keratosis, may increase the risk of skin cancer. Furthermore, the EMA advised patients who have been treated with Picato to monitor for any abnormal skin changes or growths that may occur within weeks to months after use and to seek medical attention if such symptoms arise. On February 11, LEO Laboratories voluntarily requested the withdrawal of its marketing authorization.

TopAlliance Biosciences’ TAB008 Randomized Phase III Clinical Trial Meets Primary Endpoint

On April 21, Allist Pharmaceuticals announced that the randomized Phase III clinical trial of TAB008 (a bevacizumab biosimilar) had met its prespecified primary endpoint. This primary endpoint compared the efficacy of TAB008 with Avastin by evaluating the objective response rate (ORR) in patients from both groups within 18 weeks after initiation of treatment. Bevacizumab was first approved for marketing by the U.S. Food and Drug Administration in 2004 under the brand name Avastin, and has since obtained seven indications abroad, including metastatic colorectal cancer, non-small cell lung cancer, malignant glioma, metastatic renal cell carcinoma, ovarian cancer, breast cancer, and cervical cancer.

Biotech Company Scynexis’ Antibiotic Ibrexafungerp Meets Key Phase 3 Clinical Endpoints

Recently, biotechnology company Scynexis announced that its investigational oral antifungal agent, ibrexafungerp, met both the primary and secondary endpoints in VANISH-306, the second pivotal Phase 3 clinical trial evaluating the drug in patients with vulvovaginal candidiasis (VVC). The data from this trial will support Scynexis’s submission of a New Drug Application (NDA) for ibrexafungerp for the treatment of VVC in the second half of this year.

Pharmaceutical Company Cara’s Breakthrough Itch Therapy Korsuva Meets Phase 3 Clinical Endpoints

Recently, pharmaceutical companies Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) jointly announced that Korsuva (CR845/difelikefalin) injection, developed by Cara, achieved positive top-line data in the pivotal Phase 3 KALM-2 trial evaluating its efficacy in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). Korsuva is a peripheral kappa-opioid receptor agonist. Cara and VFMCRP expect to submit a New Drug Application (NDA) for Korsuva in the second half of this year.

bioRxiv: First Preclinical Experimental Data on Inactivated SARS-CoV-2 Vaccine Released

On April 19, researchers from Sinovac Biotech Ltd., the Institute of Medical Laboratory Animal Science at the Chinese Academy of Medical Sciences, and other scientific institutions collaborated to publish an article on the preprint server bioRxiv (not yet peer-reviewed), releasing for the first time the preclinical experimental data of a purified inactivated candidate vaccine against SARS-CoV-2. The study showed that the vaccine could induce SARS-CoV-2-specific neutralizing antibodies in mice, rats, and non-human primates. These antibodies effectively neutralized 10 representative strains of SARS-CoV-2, suggesting broad neutralizing capacity against globally circulating variants. Furthermore, the vaccine demonstrated a favorable safety profile, with no evidence of antibody-dependent enhancement (ADE) observed. These findings support the rapid clinical development of human vaccines against SARS-CoV-2.

Hualan Biological Obtains “Clinical Trial Notification” for Three Specifications of Intravenous Human Immunoglobulin

On April 22, Hualan Biological Engineering Inc. announced that it had recently received the "Clinical Trial Notification" for three specifications of Intravenous Human Immunoglobulin issued by the National Medical Products Administration (NMPA). Currently, there are no similar technologies or high-concentration products of this kind available on the market in China.

Innovent Biologics’ TIGIT Monoclonal Antibody IBI939 Initiates Clinical Trials for Combination Therapy in Advanced-Stage Cancer

On April 20, according to the Insight database, Innovent Biologics initiated a Phase I clinical trial of IBI939 as monotherapy—evaluating IBI939 monotherapy and its combination with sintilimab for the treatment of advanced malignant tumors. IBI939 is the first TIGIT antibody developed in China by Innovent Biologics. The role of TIGIT in tumor immune suppression is similar to that of PD-1/PD-L1. Multiple preclinical studies have demonstrated that anti-TIGIT antibodies and anti-PD-1/PD-L1 antibodies can exert synergistic anti-tumor effects.

CStone Pharmaceuticals’ PD-L1 Antibody Approved for New Clinical Trial: Combination with Donafenib for Advanced Solid Tumors

On April 21, the Center for Drug Evaluation (CDE) announced that Cosmo Pharmaceuticals’ recombinant fully human monoclonal antibody injection targeting PD-L1 has received implicit approval for a new clinical trial. The indication is for use in combination with donafenib tosylate in the treatment of advanced solid tumors, with adjustments to the selected indications to be made based on the progress of ongoing clinical trials. It is expected that a New Drug Application (NDA) will be submitted in China in the second half of this year.

Yunding Pharma’s Trop-2-Targeted Antibody-Drug Conjugate Approved for Clinical Trials in China for the Treatment of Triple-Negative Breast Cancer

On April 20, sacituzumab govitecan, jointly submitted by Everest Medicines and Qiyun Pharmaceuticals, received clinical trial approval in China for the treatment of metastatic triple-negative breast cancer (TNBC) in patients who have received at least two prior lines of therapy. The drug has currently filed a marketing application in the United States, with a PDUFA date of June 2, 2020, and is poised to become the first antibody-drug conjugate (ADC) approved for TNBC. Sacituzumab govitecan consists of hRS7 IgG1κ, a humanized monoclonal antibody targeting trophoblast cell-surface antigen 2 (Trop-2), conjugated to the cytotoxic compound SN-38.

BoruiDa Bio’s CD30 CAR-T Therapy BRD-01 Approved for Clinical Trials in China

On April 20, BoruiDa Biologics’ autologous T-cell injection product (BRD-01), genetically modified with a chimeric antigen receptor targeting CD30, was approved for clinical trials to treat CD30-positive relapsed/refractory hematologic malignancies in patients aged 18–70 years. This marks the first CD30-targeted CAR-T cell therapy approved for clinical investigation in China. BRD-01 consists of an extracellular murine single-chain variable fragment (scFv) that specifically recognizes CD30, fused with the intracellular signaling domains of CD28, 4-1BB, and CD3ζ.

Ascendis Pharma’s TransCon Therapy for Growth Hormone Deficiency Receives FDA Orphan Drug Designation

On April 15, Ascendis Pharma announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to TransCon human growth hormone (lonapegsomatropin) for the treatment of growth hormone deficiency (GHD). TransCon human growth hormone is an investigational long-acting prodrug of growth hormone, currently developed as a once-weekly therapy for GHD. Lonapegsomatropin previously received orphan drug designation from the European Commission (EC) in October 2019 for the treatment of GHD in Europe.

Myovant’s Oral GnRH Receptor Antagonist Relugolix Files for Marketing Approval in the U.S.

Recently, healthcare company Myovant Sciences announced that it has submitted a New Drug Application (NDA) to the U.S. FDA, seeking approval for once-daily oral relugolix (120 mg) for the treatment of male patients with advanced prostate cancer. In the Phase III HERO trial, relugolix demonstrated a response rate of 96.7%, significantly superior to leuprolide acetate.

Vaxart Plans to Advance COVID-19 Vaccine Candidate into Clinical Trials

Recently, vaccine developer Vaxart has obtained positive preclinical results for its COVID-19 candidate vaccines, with some of these candidates eliciting an immune response in all tested animals after a single dose. The company now plans to advance one or more of these candidates into clinical trials.

Gilead Partners with oNKo-innate to Develop NK Cell Immunotherapy

On April 21 local time, Kite Pharma, a subsidiary of Gilead Sciences, and the biotechnology company oNKo-innate announced that they have initiated a three-year research collaboration in cancer immunotherapy. This partnership aims to support the discovery and development of next-generation drugs and cell therapies with a focus on natural killer (NK) cells. Through this collaborative effort, oNKo-innate will leverage its genome-wide screening technologies and proprietary technology platforms to identify novel immune cell targets, enhance NK cell-mediated anti-tumor immunity, and develop NK cell-based therapies. Additionally, oNKo-innate will assist Gilead in launching its immuno-oncology discovery program.

Merck Invests €100 Million to Enhance Manufacturing Capabilities for Commercial Viral Vectors and Gene Therapy Products

On April 21, leading technology company Merck announced the construction of its second facility in Carlsbad, California, to deliver its BioReliance® viral and gene therapy services. The new commercial facility, valued at €100 million, is expected to open next year, more than doubling existing production capacity to support large-scale commercial manufacturing of viral vectors and gene therapy products.

Hualan Biological Engineering Inc. Plans to Spin Off Hualan Vaccine for Independent Listing

On the evening of April 20, Hualan Biological Engineering Inc. publicly announced its spin-off plan. According to the announcement, Hualan Biological intends to spin off its controlling subsidiary, Hualan Vaccine Co., Ltd., for listing on the ChiNext Board of the Shenzhen Stock Exchange, after the subsidiary completes its overall conversion into a joint-stock limited company. Hualan Vaccine has developed into China’s largest production base for influenza vaccines and is one of the enterprises in China’s vaccine industry with a relatively diverse product portfolio and comprehensive specifications. Its currently marketed vaccines include split-virion influenza vaccine, split-virion influenza A (H1N1) vaccine, quadrivalent split-virion influenza vaccine, group A and group C meningococcal polysaccharide vaccine, group A, C, Y, and W135 meningococcal polysaccharide vaccine, and recombinant hepatitis B vaccine (Hansenula polymorpha yeast).

TopAlliance Biosciences Appoints Dr. Liu Jun as Chief Operating Officer

Recently, TopAlliance Biosciences Inc. announced the appointment of Dr. Liu Jun as Chief Operating Officer to assist Huang Chunying, General Manager of TopAlliance Biosciences, in jointly advancing the company’s overseas business development. Dr. Liu joined TopAlliance Biosciences on October 17, 2016, and currently serves as Executive Director and Chief Scientific Officer, overseeing new product research and development as well as product quality control. Previously, Dr. Liu Jun served as Executive Director of the Biologics Research and Development Department at ChemPartner, Senior Scientist at Bayer Healthcare’s Global Biologics R&D Center in the United States, and Principal Investigator in the Department of Immunology at the Beckman Research Institute in California, USA.

WuXi Biologics Completes Acquisition of a German Biologics Manufacturing Facility

On April 22, WuXi Biologics announced the formal completion of its acquisition of a biologics manufacturing facility owned by Bayer in Leverkusen, Germany. Under the agreement reached in January, WuXi Biologics has taken over the plant’s operations, purchased relevant equipment, and secured a long-term lease for the facility. Equipped with industry-leading aseptic filling lines, the German plant will provide aseptic filling and lyophilized formulation services upon becoming operational, with an annual production capacity of up to 10 million vials.

Jiangsu Provincial Medical Products Administration Issues "Implementation Opinions on Promoting Sunshine Procurement of Drugs (Trial)"

On April 22, the Jiangsu Provincial Healthcare Security Administration held a press briefing to release the “Implementation Opinions on Promoting Sunshine Procurement of Pharmaceuticals (Trial).” Effective May 1, innovative drugs and newly approved and registered drugs within the past year will be given priority for listing on Jiangsu’s online procurement platform. The Opinions aim to establish a transparent and open pharmaceutical procurement system, foster a fair and equitable market competition environment, focus on reducing drug prices, ensure drug quality and supply, promote the coordinated reform of medical care, health insurance, and pharmaceuticals (“Three-Medical” linkage), and further deepen comprehensive healthcare system reforms.

Sichuan Ensures Patients Across the Province Access Price-Reduced Drugs by End of April, with an Average Price Cut of 73%

Currently, Sichuan Province is actively and systematically advancing the second batch of centralized drug procurement, ensuring that patients across the province can access price-reduced medications by the end of April 2020. This round of centralized procurement includes a total of 32 drugs, with an average price reduction of 73%, which will further benefit patients in Sichuan Province. It is reported that the 32 selected drugs from this national centralized drug procurement cover conditions such as diabetes, hypertension, coronary heart disease, malignant tumors, and Alzheimer's disease.

*Nat Commun*: Researchers Develop Electronic Cells Capable of Learning Like the Human Brain

Recently, a research team from the University of Massachusetts Amherst claimed to have identified an artificial substitute for neural synapses. In their study of protein nanowires, they proposed a design for a neuromorphic memristor, or “memtransistor,” that operates at voltage levels comparable to those found in the human brain. A study detailing this technology was published in Nature Communications. By passing tiny pulses of positive and negative charges through the nanowires within the memristor, the researchers were able to create new imprints and connections internally. The researchers stated that this process mimics the way the human brain learns, forming new connections as memories.

Cell: Development of the PAC-MAN Method for Efficient Targeted Degradation of Influenza Virus and SARS-CoV-2

Recently, in a new study, researchers from Stanford University and other institutions proposed an alternative antiviral strategy that relies on a CRISPR-based system to identify and degrade intracellular viral genomes and the viral mRNA they produce (Figure 1B). By targeting both the positive-sense genome and viral mRNA for simultaneous degradation of the viral genomic templates used for replication and gene expression, this approach is expected to robustly restrict viral replication. The related findings have been published online as a manuscript in the journal Cell.

Frontiers in Cell and Developmental Biology: Scientists Unveil a Novel Mechanism for Mitochondrial Self-Repair

Recently, a research team led by Liu Xingguo, a researcher at the Guangzhou Institutes of Biomedicine and Health, Chinese Academy of Sciences, in collaboration with multiple research groups including Wuhan University, unveiled a novel mechanism for mitochondrial self-functional repair. The related study was published online in Frontiers in Cell and Developmental Biology. Liu Xingguo’s team discovered that exon 4b of OPA1 directly regulates mitochondrial respiration to restore self-energy supply, independent of mitochondrial fusion. Mechanistic studies indicated that OPA1 exon 4b regulates the structure of mitochondrial DNA nucleoids, specifically binds to the D-loop region of mitochondrial DNA to modulate its transcription, repairs the electron transport chain, and ultimately restores mitochondrial respiratory function. This study demonstrates a novel OPA1 exon 4b-mediated mechanism for mitochondrial functional repair that is independent of mitochondrial fusion, and further reveals that this splice variant facilitates mitochondrial metabolic reprogramming in hepatocellular carcinoma.

Cell: Scientists Reveal How Small-Molecule Drugs Exert Anticancer Effects

Recently, scientists at the University of Michigan discovered that the small molecule DT-061 can specifically stabilize the B56α-PP2A holoenzyme, thereby enabling its dephosphorylation activity to exert anticancer effects. This research was published in the journal Cell. The researchers also noted that PP2A is dysregulated in other diseases beyond cancer, including cardiovascular and neurodegenerative disorders. Therefore, this finding also provides opportunities for developing new drugs to treat conditions such as heart failure and Alzheimer’s disease.

Nature: Study Reveals How Malignant Brain Tumors Evade Chemotherapy and Immunotherapy

Recently, scientists from Boston and Paris published an analysis of more than 10,000 gliomas and clinical outcomes in the journal Nature. The analysis revealed that checkpoint inhibitor therapy showed no significant efficacy in patients with hypermutated gliomas. These findings further underscore the challenges posed by malignant brain tumors. Malignant brain tumors are initially treated with surgery, but complete resection is difficult to achieve, necessitating systemic radiotherapy and chemotherapy. The study also indicated that treatment with temozolomide, the standard chemotherapy drug for gliomas, may induce tumor hypermutation and lead to resistance to subsequent therapies.

《Cell》: Discovery of the First Protein That Regulates Fatty Acid Synthase

Recently, in a new study, Holger Stark and Ashwin Chari from the Max Planck Institute for Biophysical Chemistry in Germany, along with their colleagues, discovered a protein that controls FAS function. This discovery opens up a new therapeutic pathway, particularly for tuberculosis. In biotechnological applications, this new control unit can produce customized FAS and special products that utilize only crude oil refining. This paves the way for "green biotechnology," and the relevant research findings were recently published in the journal Cell.