Aimisen Secures Tens of Millions in Series A Funding; Haijingge Pharma Completes Series B Round and Files IPO Prospectus

Haijinge Pharma Announces Completion of Series B Financing

On April 27, Haijinge Pharma announced the completion of its Series B financing, with the investors and amount undisclosed. The company stated that its clinical research operations, which had been suspended due to the pandemic, have now fully resumed, accelerating its dual-driven development powered by both business operations and capital. Beijing Haijinge Pharmaceutical Technology Co., Ltd. is a contract research organization (CRO) specializing in providing Phase I–IV clinical trials and related technical services to pharmaceutical companies, medical device manufacturers, and new drug research institutions.

Ameson Completes Tens of Millions in Series A Financing to Boost Early Cancer Detection

On April 27, 2020, Wuhan Imesen Life Technology Co., Ltd. announced the completion of its Series A financing round, raising tens of millions of yuan from the CCB Medical Growth Fund. The funds will be used to accelerate the development and market expansion of the company’s early-stage cancer detection products.

Yaozhi.com Completes Tens of Millions in Series A Financing, Accelerating Its Expansion in the Greater Health Sector

Recently, Kangzhou Big Data (Yaozhi.com) completed an A-round financing of tens of millions of yuan. The funds will accelerate the company’s strategic layout in digital economy technologies—including big data, artificial intelligence, pharmaceutical industry internet, and cloud computing—as well as in the broader health sector led by biopharmaceuticals. This achievement lays a solid foundation for establishing a new pattern of industrial development and provides strong support for the company’s comprehensive entry into new industries, new business formats, and new models within the pharmaceutical digital economy.

Xunminkang Completes Tens of Millions in Series A Financing for New Product R&D

Recently, Xunminkang, a clinical microbiology precision diagnostics company, announced the completion of its tens-of-millions-yuan Series A financing round, invested by Xinran Capital. Li Ziqin, Co-founder and General Manager of Xunminkang, stated that the funds from this round will be used for new product development, establishment of new technology platforms, as well as optimization, upgrading, and promotion of existing products.

Zhifei Biologicals’ Class 1 Novel Drug, Recombinant Mycobacterium tuberculosis Fusion Protein, Approved for Market Launch

Recently, the recombinant Mycobacterium tuberculosis fusion protein developed by Anhui Zhifei Longcom Biopharmaceutical Co., Ltd. has been approved for marketing by the National Medical Products Administration (NMPA). This product will be used for: 1. Screening for Mycobacterium tuberculosis infection; 2. In combination with purified protein derivative (PPD) of tuberculin, primarily to differentiate between Bacille Calmette-Guérin (BCG) vaccination and Mycobacterium tuberculosis infection; 3. Distinguishing among three groups—individuals who revert to negative or remain uninfected after BCG vaccination, those who remain positive after BCG vaccination, and those infected with Mycobacterium tuberculosis—to facilitate the administration of different types of vaccines to each group; and 4. Clinical auxiliary diagnosis of tuberculosis.

Eight Drugs, Including Yimucao Soft Capsules, Reclassified as Over-the-Counter Medications

Recently, the National Medical Products Administration (NMPA) issued an announcement on converting eight drugs, including Yimucao Soft Capsules, from prescription to over-the-counter (OTC) status. The specific products listed are Yimucao Soft Capsules, Andrographolide Dispersible Tablets, Antiviral Capsules, Omeprazole Magnesium Enteric-coated Tablets, Omeprazole Enteric-coated Capsules, Metronidazole Mouthwash, Sodium Hyaluronate Eye Drops, and Vitamin C Chewable Tablets. Among these, five are classified as Class A OTC drugs, and five are dual-status drugs (available as both prescription and OTC).

Henlius Announces NMPA Approval of Hanlikang® 500 mg Strength

On April 24, 2020, Henlius announced that the company’s supplemental application for drug registration to add a new specification of its first product, Hanlikang® (generic name: Rituximab Injection), specifically 500 mg/50 mL per vial, had been officially approved by the National Medical Products Administration (NMPA). Following the approval of the supplemental application for the 2,000-liter production scale of Hanlikang®, the approval of the 500 mg specification marks the entry of Hanlikang®’s commercial production into a phase of comprehensive acceleration. Previously, Hanlikang® (100 mg/10 mL per vial) had received formal approval from the NMPA in February 2019 and is primarily indicated for the treatment of non-Hodgkin lymphoma.

Biopharmaceutical Company Puma Bio’s New Drug Nerlynx Launches in Singapore, Reducing Recurrence Risk by 42%

Recently, biopharmaceutical company Puma Biotechnology announced that its licensing partner, Specialised Therapeutics Asia (STA), has launched Nerlynx (neratinib) in Singapore. This targeted therapy for breast cancer is indicated for extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have completed prior adjuvant trastuzumab-based therapy. Nerlynx is an oral medication intended for female patients with HER2-positive early-stage breast cancer who have previously undergone surgery, chemotherapy, and adjuvant trastuzumab treatment.

FDA Approves Supplemental New Drug Application for Pfizer’s Crisaborole Ointment (2%) for the Treatment of Atopic Dermatitis

Recently, Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for crisaborole ointment (2%), expanding the age indication for pediatric patients with mild-to-moderate atopic dermatitis (AD; eczema) from 24 months down to 3 months of age. Crisaborole was previously approved for use in adults and children aged 2 years and older. This supplemental approval makes crisaborole the first and only non-steroidal topical prescription medication indicated for patients aged 3 months to 2 years with mild-to-moderate atopic dermatitis (AD; eczema).

AstraZeneca and Merck Announce Positive Phase 3 Clinical Results for Targeted Cancer Drug Olaparib, Extending Overall Survival in Prostate Cancer Patients

Recently, AstraZeneca and Merck announced further positive results from the Phase III PROfound trial evaluating the targeted anticancer drug Lynparza (olaparib) for the treatment of prostate cancer. The trial results demonstrated that, in patients with metastatic castration-resistant prostate cancer (mCRPC) harboring BRCA1/2 or ATM gene mutations (a subset of homologous recombination repair [HRR] gene mutations), Lynparza treatment yielded statistically significant and clinically meaningful improvements in the key secondary endpoint of overall survival, compared with enzalutamide or abiraterone.

Johnson & Johnson’s Anti-Inflammatory Drug Simponi Aria Submits Application to FDA for the Treatment of Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis

Recently, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, announced that it had submitted two supplemental Biologics License Applications to the U.S. FDA, seeking approval for the anti-inflammatory drug Simponi Aria (golimumab), in combination with methotrexate, for the treatment of polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis in patients aged 2 years and older. If approved, Simponi Aria would become the first intravenously administered tumor necrosis factor (TNF)-α biologic agent available for treating these forms of juvenile arthritis.

Roche’s Satralizumab Significantly Reduces Relapse Risk in Phase 3 Clinical Trial for NMOSD

Recently, Chugai Pharmaceutical, a Japanese pharmaceutical company under Roche Holding, announced that the results of the global Phase III clinical trial SAkuraStar, which evaluated satralizumab as monotherapy for neuromyelitis optica spectrum disorder (NMOSD), have been published online in The Lancet Neurology. The results showed that satralizumab monotherapy significantly reduced the risk of relapse in NMOSD patients compared with placebo, and demonstrated favorable tolerability and safety.

FDA Approves RemeGen’s Novel ADC Drug RC48 for Direct Entry into Phase II Clinical Trials

Recently, RC48 (disitamab vedotin; brand name: AidiXi), an antibody-drug conjugate (ADC) independently developed by RemeGen, has received FDA approval to directly initiate a Phase II clinical trial in the United States for the treatment of HER2-positive locally advanced or metastatic urothelial carcinoma.

Biotech Firm Mesoblast’s Mesenchymal Stem Cell Therapy Remestemcel-L Shows Efficacy, with 88% Survival Rate in Moderate to Severe Acute Respiratory Distress Syndrome

Currently, remestemcel-L is being used in the United States to treat acute respiratory distress syndrome (ARDS) in patients with novel coronavirus pneumonia (COVID-19) through expanded access compassionate use programs and randomized controlled clinical trials. Recently, Mesoblast announced the initial treatment data for remestemcel-L: between March and April, 12 COVID-19 patients with moderate-to-severe ARDS who were dependent on mechanical ventilation received remestemcel-L treatment. Of these, 10 patients survived, yielding a survival rate of 83%. Patients received two intravenous infusions of remestemcel-L over the first five days. Seventy-five percent of the patients were weaned off mechanical ventilation within a median of 10 days, and seven patients have been discharged to date. All patients received remestemcel-L at Mount Sinai Hospital in New York City under either an emergency investigational new drug application or an expanded access protocol.

Johnson & Johnson’s Anti-Cancer Drug Darzalex, in Combination with RVd Regimen, Significantly Improves Efficacy as First-Line Treatment for Newly Diagnosed Multiple Myeloma Patients Undergoing Stem Cell Transplantation

A recent study published in Blood, a top-tier journal in the field of hematology, demonstrated that compared with the RVd regimen, the combination of Johnson & Johnson’s anticancer drug Darzalex (Chinese brand name: Zhaokesi®; generic name: daratumumab) with RVd (D-RVd) significantly improved efficacy without introducing new safety concerns. The drug is indicated for adult patients with relapsed and refractory multiple myeloma who have received prior therapies including a proteasome inhibitor and an immunomodulatory agent and whose disease progressed during or after their last treatment.

Biopharmaceutical Company Poxel’s Diabetes Drug Imeglimin Demonstrates Favorable Safety and Tolerability in Two Trials

Recently, biopharmaceutical company Poxel SA announced the results of two clinical studies on its novel oral antidiabetic drug, imeglimin. These two studies evaluated the potential for interactions between imeglimin and two widely prescribed antidiabetic agents: metformin (a biguanide) and sitagliptin (a DPP-4 inhibitor). The results showed that co-administration of imeglimin with either metformin or sitagliptin did not cause clinically relevant pharmacokinetic interactions in healthy subjects.

World’s First Autologous CD7-CAR-T Cell Therapy Clinical Trial Shows Positive Progress: ORR of 100% in the First Three Patients

Recently, a research team from China has achieved a breakthrough in the development of cellular therapies for T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL). In a clinical trial led by Professor Zhang Mingzhi from the First Affiliated Hospital of Zhengzhou University, evaluating autologous CD7-CAR-T cell therapy for patients with refractory or relapsed T-ALL/LBL, the first three enrolled patients achieved an overall response rate (ORR) of 100%, with two patients attaining complete remission (CR) and one patient achieving partial remission (PR).

Green Valley Pharmaceuticals’ New Alzheimer’s Drug, Sodium Oligomannate Capsules, Receives FDA Approval for Phase III Clinical Trials

On April 8, Green Valley Pharmaceuticals received official notification from the U.S. Food and Drug Administration (FDA) approving the Investigational New Drug (IND) application for the international multicenter Phase III clinical trial of its proprietary novel drug for Alzheimer’s disease, Sodium Oligomannate capsules (brand name: Nine-Period One®; English name: Sodium Oligomannate). The approval became effective on April 3. The entire international multicenter Phase III clinical trial is scheduled to be completed in 2024, with the aim of submitting the new drug registration application in 2025.

Hengrui Medicine Initiates Phase II Clinical Trial of PD-1 Inhibitor Combined with Famitinib for Advanced Solid Tumors

On April 24, Hengrui Medicine registered the initiation of a Phase II study evaluating camrelizumab in combination with famitinib for the treatment of advanced solid tumors. The principal investigator of this trial is Professor Fan Jia from Zhongshan Hospital, Fudan University. The primary endpoint is objective response rate, while secondary endpoints include duration of response, disease control rate, and progression-free survival assessed by imaging.

GSK Announces Latest Analysis Data from the Phase I/II GARNET Clinical Study of the Anti-PD-1 Therapy Dostarlimab

Recently, GlaxoSmithKline announced the latest analysis data from the GARNET Phase I/II clinical study of dostarlimab (formerly TSR-042), an anti-PD-1 therapy. The results showed that dostarlimab treatment provided clinically meaningful outcomes in patients with recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer who experienced disease progression during or after platinum-based chemotherapy.

China’s First Inactivated COVID-19 Vaccine Enters Phase II Clinical Trials

On April 24, the inactivated COVID-19 vaccine jointly developed by Sinopharm’s Wuhan Institute of Biological Products and the Wuhan Institute of Virology, Chinese Academy of Sciences, officially entered Phase II clinical trials. As of April 23, Sinopharm’s inactivated COVID-19 vaccine had completed vaccination for 96 participants across the first three age groups in the initial phase. Current data indicate a favorable safety profile, and ongoing safety monitoring continues.

CT053 from CARsgen Therapeutics Receives EMA Orphan Drug Designation for the Treatment of Multiple Myeloma

On April 27, 2020, Carsgen Therapeutics (Shanghai) Co., Ltd., a developer of CAR-T cell immunotherapies, announced that its application for orphan drug designation for its fully human BCMA CAR-T cell therapy (CT053) for the treatment of multiple myeloma had received a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA).

Biotech Company AGC Biologics Partners with AdaptVac to Develop and Manufacture COVID-19 Vaccine

On April 27, 2020, AGC Biologics, a global contract development and manufacturing organization (CDMO) in the biopharmaceutical industry, announced that it would collaborate with AdaptVac to develop and manufacture a vaccine against COVID-19. AdaptVac is working together with its joint partners in the PREVENT-nCoV consortium, sponsored by the European Union’s Horizon 2020 program, to develop a SARS-CoV-2 vaccine. As the COVID-19 pandemic continues to spread, AdaptVac’s virus-like particle (VLP) technology offers a solution to prevent new SARS-CoV-2 infections.

Johnson & Johnson Announces Strategic Partnership with Emergent BioSolutions to Manufacture Primary COVID-19 Vaccine Candidate

Recently, Johnson & Johnson announced that its Janssen Pharmaceuticals has entered into a strategic partnership with Emergent BioSolutions to support the manufacturing of its lead COVID-19 vaccine candidate. Earlier, Johnson & Johnson stated its plan to rapidly expand production capacity to ensure a global supply of more than one billion safe and effective vaccines.

Eli Lilly to Begin Human Trials of COVID-19 Investigational Drug as Early as May

Recently, pharmaceutical manufacturer Eli Lilly announced that it expects to begin human trials of an experimental therapy for coronavirus disease 2019 (COVID-19) as early as next month. The therapy utilizes antibodies extracted from the blood of patients who have recovered from the viral disease. David Ricks, CEO of Eli Lilly, stated that results from these trials could be available by late summer, and if successful, the therapy is poised to receive emergency use authorization from the U.S. Food and Drug Administration (FDA) in early autumn.

Novo Nordisk Announces Launch of “China Co-Innovation” Initiative to Facilitate China’s Inclusion in Global Simultaneous Clinical Trials

On April 27, 2020, Novo Nordisk announced the launch of the “China Co-Creation” initiative. This program serves as a practical operational guide for advancing China’s integration into global synchronized clinical trials and achieving simultaneous global submission of new drug applications from clinical trial stages. It aims to accelerate the research, development, and registration of innovative products in China, enabling Chinese patients to benefit simultaneously from global pharmaceutical innovations. Furthermore, in the fields of academic research and clinical trials, Novo Nordisk pioneered the Strategic Collaboration Center model to strengthen academic exchanges with Chinese hospitals and jointly enhance the clinical research capabilities of domestic hospitals.

Hua Medicine Announces Successful Results of Clinical Study on Dorzagliatin in Combination with Empagliflozin

On April 27, 2020, Hua Medicine (Shanghai) Co., Ltd. announced the successful results of clinical study HMM0112. HMM0112 was a Phase I clinical trial conducted in the United States to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of dorzagliatin and empagliflozin (an SGLT-2 inhibitor), administered either as monotherapy or in combination, in patients with type 2 diabetes whose blood glucose levels were not adequately controlled with metformin, DPP-4 inhibitors, or SGLT-2 inhibitors alone or in combination. The pharmacokinetic results demonstrated that co-administration of dorzagliatin (75 mg BID) and empagliflozin (25 mg QD) did not affect their respective PK profiles, supporting their combined oral administration.

Boyaa Holding Group’s Overseas Subsidiary TG Medical Is Developing New Therapies for COVID-19

Recently, TG Medical, a subsidiary of Boya Holdings Group, announced its full commitment to the strategic development of fully human antibody therapies for COVID-19. It is reported that TG Medical is leveraging its proprietary platform and patented collaborative technologies to develop a series of novel therapeutic approaches designed to prevent SARS-CoV-2 from entering human lung cells and to treat COVID-19. These include antiviral sera, polyclonal antibody drugs, and monoclonal antibody drugs. Currently, TG Medical’s rapid antibody test kit for SARS-CoV-2 has received FDA approval for market launch, and the company’s patented cell preparation technology is being utilized for the production of antiviral sera as well as the screening and manufacturing of various antibody-based therapeutics.

Zhejiang Medicine Plans to Invest RMB 1.642 Billion in Keming Biology to Adjust Industrial Structure

Recently, Zhejiang Medicine Co., Ltd. announced that, in order to adjust its industrial structure, the company plans to invest RMB 1.642 billion in the construction of Phase I of Zhejiang Keming Biopharmaceutical Co., Ltd. The announcement stated that Keming Biopharmaceutical has planned a land area of approximately 600 mu, with a construction period from 2020 to 2030. The project will be implemented in two phases in accordance with the principle of “overall planning and phased implementation.” Its industrial positioning is as a production base for biopharmaceuticals, pharmaceutical formulations, and life nutrition products, while also considering the layout of the broader health industry. The company aims to address its future development primarily by “revitalizing existing assets and expanding new growth.”

"Cellular and Molecular Immunology": Scientists Clone Antibodies from Recovered Patients, Offering Hope for Treating Novel Coronavirus

Recently, researchers at Tsinghua University successfully cloned a neutralizing antibody against SARS-CoV-2 from individuals who had recovered from COVID-19. In laboratory tests, this cloned antibody was shown to block the virus from binding to receptors on host cells, suggesting that it could prevent viral infection in humans. Although these findings are promising, it remains unclear whether the antibody can effectively prevent viral entry in the human body. The study was published in the journal Cellular & Molecular Immunology.