ZhenGene Bio and Innovent's PD-1 Inhibitor Tyvyt® Granted Orphan Drug Designation by FDA

Rendu Bio's Nucleic Acid Testing Products Receive Emergency Approval from the National Medical Products Administration

It is reported that the National Medical Products Administration (NMPA) has granted emergency approval for RenDu Bio’s nucleic acid test kit for the novel coronavirus (2019-nCoV). This is currently the only approved nucleic acid test kit utilizing the RNA capture probe method. According to the NMPA website, RenDu Bio’s 2019-nCoV nucleic acid test kit employs RNA-specific target capture and transcription-mediated isothermal amplification with real-time detection. The kit automates nucleic acid extraction and amplification within a single reaction tube, delivering results in 90 minutes and enabling continuous parallel testing to improve detection efficiency. As of March 27, the NMPA had granted emergency approval for 23 novel coronavirus testing products, including eight antibody test kits.

Abbott’s Diagnostic Test Receives U.S. FDA Emergency Use Authorization, Delivering COVID-19 Results in 5 Minutes

On March 27, Abbott announced on its official website that its diagnostic test had received Emergency Use Authorization (EUA) from the U.S. FDA. This product is the fastest point-of-care molecular diagnostic test for detecting the novel coronavirus (COVID-19), delivering positive results in as little as 5 minutes and negative results in 13 minutes. The test can be utilized outside traditional testing settings, such as in physicians’ offices or emergency clinics.

State Council Joint Prevention and Control Mechanism: Local Transmission of the Epidemic Has Been Basically Interrupted

On March 29, at a press conference held by the Joint Prevention and Control Mechanism of the State Council, Mi Feng, Spokesperson for the National Health Commission and Deputy Director of the Department of Publicity, stated that as of March 28, the number of existing confirmed cases had dropped below 3,000, effectively interrupting local transmission of the epidemic. A cumulative total of 693 imported confirmed cases have been reported, originating from 42 countries; among these, seven countries with higher case numbers account for 83.4% of the total, indicating a significant risk of triggering new rounds of transmission and spread. At present, it remains essential to guard against the dual risks of sporadic local cases and transmission from imported cases, ensuring timely detection, rapid response, and targeted prevention and control measures.

China's Anti-Epidemic Medical Expert Team Arrives in Laos, with Aid Supplies for Pandemic Control Delivered on the Same Flight

On March 29, the Chinese Medical Expert Team for Epidemic Control arrived in Vientiane, the capital of Laos. The team also brought with them medical supplies donated by China, including materials for medical treatment, personal protective equipment (PPE), and both traditional Chinese and Western medicines. The 12-member team comprises healthcare experts from Yunnan Province specializing in various fields such as infection prevention and control, intensive care, epidemiology, and laboratory testing. According to Huang Xingli, head of the expert team, their primary mission is to share experiences and engage in exchanges with local hospitals and experts, introduce China’s epidemic control practices, provide consultations on epidemic prevention and control, patient treatment, and laboratory operations in light of Laos’ existing preventive measures and clinical protocols, and offer training and guidance to medical personnel and community-based epidemic control staff.

Philippines Says Chinese-Donated Test Kits Meet WHO Standards, Issues Apology

On March 29, the Philippine Department of Health issued a public statement clarifying concerns regarding the quality of COVID-19 testing kits donated by China. The statement clarified that the BGI Genomics nucleic acid test kits and Sansure Biotech nucleic acid test kits, donated by the Chinese government, were evaluated by the Research Institute for Tropical Medicine in the Philippines and found to have performance levels comparable to those of the test kits provided by the World Health Organization. The Philippine government stated that there was no need to separately purchase additional test kits and expressed apologies for the misunderstandings caused by its earlier announcement.

Chloroquine Drugs Receive FDA Emergency Use Authorization for the Treatment of COVID-19

On March 28, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) permitting the distribution and use of hydroxychloroquine sulfate and chloroquine phosphate products donated to the U.S. Strategic National Stockpile (SNS) for certain hospitalized patients with coronavirus disease 2019 (COVID-19). These medications will be distributed from the SNS to states, allowing physicians to prescribe them at their discretion for hospitalized adolescent and adult patients with COVID-19 when clinical trials are unavailable or not feasible. Under the Federal Food, Drug, and Cosmetic Act, the authorized chloroquine phosphate and hydroxychloroquine sulfate products are limited to those provided by the Strategic National Stockpile (SNS) to public health authorities.

Gilead Chairman: Remdesivir Provided to Over 1,000 Patients; Preliminary Data Expected Within Weeks

On March 29, Gilead Sciences’ official WeChat account released “An Open Letter from Daniel O’Day, Chairman and CEO of Gilead Sciences, on Remdesivir.” In the letter, Daniel O’Day, Chairman and CEO of Gilead Sciences, stated that multiple studies on remdesivir, a potential therapeutic agent for COVID-19 developed by the company, are currently underway. “We expect to obtain preliminary data in the coming weeks. If the drug is approved, we will ensure its affordability and accessibility so that patients with urgent needs can receive remdesivir.”

MFA: Chinese Government Decides to Dispatch Medical Expert Team to Venezuela, with Experts Selected from Jiangsu Province

On March 30, 2020, the Ministry of Foreign Affairs announced that, to assist Venezuela in responding to the COVID-19 pandemic, the Chinese government had decided to dispatch a medical expert team for epidemic control to Venezuela. The team was organized by the National Health Commission and selected by the Health Commission of Jiangsu Province. It departed on March 29 and arrived on March 30.

ZhenGe Biologics Completes $51 Million Series A Financing to Expand R&D Center

On March 30, 2020, ZhenGe Biologics, a high-tech enterprise engaged in CDMO services for macromolecular biologics and the development and production of cell culture media formulations, announced the completion of its $51 million Series A financing round in March 2020. The round was led by LYFE Capital, with participation from IDG Capital, Cowin Capital, Korea Investment Partners (KIP), Junxin Capital, and Guofang Fund of Funds. The proceeds will be primarily used for talent acquisition, expansion of R&D centers, construction of a GMP manufacturing base in the Lingang New Area of the Shanghai Pilot Free Trade Zone (including pilot-scale and commercial GMP manufacturing of macromolecular biologics, commercial GMP production of cell culture media, and a pilot-scale GMP manufacturing base for ADC drugs), as well as the establishment of an R&D laboratory in the United States.

Xiangxue Pharmaceutical Plans Private Placement to Raise Up to RMB 1.4 Billion for Capacity Expansion of Xiangxue Antiviral Oral Liquid and Other Projects

On March 19, Xiangxue Pharmaceutical disclosed its plan for the 2020 private placement of shares. The total amount of funds to be raised through this private share issuance shall not exceed RMB 1.4 billion (inclusive). The net proceeds, after deducting issuance expenses, will be entirely allocated to the following projects: RMB 280 million for Phase I of the Shanwei Medical Protective Products Manufacturing Base Construction Project; RMB 220 million for the Capacity Expansion Project of Xiangxue Antiviral Oral Liquid; RMB 200 million for the Deqing Southern Chinese Medicinal Herbs Industrial Park Construction Project; RMB 100 million for the Xiangxue Precision TAEST16001 Cell Therapy Project; RMB 240 million for the Introduction of Varieties Such as Oral Paclitaxel (Oraxol); and RMB 360 million for replenishing working capital.

53 Batches of Drugs in Guangxi and 33 Batches in Jiangxi Found Substandard, Mostly Traditional Chinese Medicine Decoction Pieces

Recently, the Drug Administration of Guangxi Zhuang Autonomous Region and the Drug Administration of Jiangxi Province respectively released the "Drug Quality Bulletin of the Drug Administration of Guangxi Zhuang Autonomous Region (First Issue of 2020)" and the "Announcement on Information Regarding Drug Supervision and Sampling Inspection in Jiangxi Province for 2020 (Issue No. 2)." The bulletins indicated that recent drug sampling inspections revealed 53 batches of drugs in Guangxi and 33 batches of drugs in Jiangxi failed to meet standard specifications. Among these, the majority of non-compliant drugs were traditional Chinese medicine decoction pieces.

AbbVie’s Humira Approved in China for Its Sixth Indication: Treatment of Adult Non-Infectious Uveitis

On March 30, 2020, AbbVie announced that the China National Medical Products Administration had approved Humira® (adalimumab injection) on March 24, 2020, for the treatment of adult patients with non-infectious intermediate uveitis, posterior uveitis, and panuveitis who have an inadequate response to corticosteroids, require corticosteroid-sparing therapy, or are unsuitable for corticosteroid treatment. This marks the sixth indication approved for Humira® in China. Humira® is currently the first and only biologic agent approved in China for the treatment of non-infectious intermediate, posterior, and panuveitis in adults.

New Drug Ozanimod for Relapsing Multiple Sclerosis Approved by FDA

Recently, the U.S. Food and Drug Administration (FDA) approved a new immunomodulatory therapy, ozanimod, for the treatment of adult patients with relapsing forms of multiple sclerosis. The drug is also in late-stage clinical development for adult and pediatric patients with moderately to severely active ulcerative colitis and Crohn’s disease. Ozanimod is a novel oral selective sphingosine-1-phosphate (S1P) receptor modulator that binds with high affinity and selectivity to the S1P1 and S1P5 receptor subtypes.

AstraZeneca’s Imfinzi Receives FDA Approval for First-Line Treatment of Small Cell Lung Cancer

On March 30, AstraZeneca announced that Imfinzi (durvalumab) has been approved in the United States as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC), to be used in combination with standard-of-care (SoC) chemotherapy consisting of etoposide plus either carboplatin or cisplatin (platinum-etoposide). The FDA approval was based on positive results from the Phase 3 CASPIAN clinical trial, which demonstrated that Imfinzi combined with SoC platinum-etoposide yielded a statistically significant and clinically meaningful improvement in overall survival (OS) compared with SoC chemotherapy alone.

GSK’s Pioneering Attachment Inhibitor Fostemsavir Demonstrates Robust Efficacy in Treating Patients with Multidrug-Resistant HIV

Recently, data from the pivotal Phase III BRIGHT clinical trial (NCT02362503) of fostemsavir, an investigational drug developed by ViiV Healthcare, an HIV-focused company controlled by GlaxoSmithKline (GSK), for the treatment of individuals with multidrug-resistant HIV infection, were published in the New England Journal of Medicine, a premier international medical journal. The study results showed that, based on the adjusted mean decline in HIV-1 RNA from Day 1 to Day 8 in the randomized cohort, the primary endpoint analysis demonstrated the superiority of fostemsavir over placebo (declines of 0.79 and 0.17 log10 copies/mL, respectively; p < 0.0001 in the intent-to-treat-exposed [ITT-E] population).

Biopharmaceutical Company Esperion Announces Latest Data on Two New Cholesterol-Lowering Drugs

Recently, biopharmaceutical company Esperion Therapeutics announced pooled analysis data from two of the four Phase III clinical trials for its new cholesterol-lowering drug Nexletol (bempedoic acid, 180 mg), as well as results from the Phase II study (1002-058) of its new combination cholesterol-lowering drug Nexlizet (bempedoic acid/ezetimibe, 180 mg/10 mg). The results showed that in study 1002-058, Nexlizet significantly reduced low-density lipoprotein cholesterol (LDL-C) by 40% compared with placebo, lowered high-sensitivity C-reactive protein (hsCRP, an inflammatory marker) by 25% relative to baseline, and did not worsen glycemic control. In this study, the incidence of adverse events with Nexlizet was comparable to that with placebo.

Bristol Myers Squibb’s New Multiple Sclerosis Drug Ozanimod Recommended for Approval by EU CHMP

Recently, Bristol Myers Squibb (BMS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of Zeposia (ozanimod) for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS). Zeposia is an oral selective sphingosine-1-phosphate (S1P) receptor modulator that binds with high affinity and selectivity to S1P receptor subtypes 1 (S1P1) and 5 (S1P5).

Janssen Pharmaceuticals Announces Phase 3 Clinical Trial Results of Xarelto Plus Aspirin, Demonstrating Significant Benefits for PAD

Recently, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, announced that the VOYAGER PAD study, which evaluated Xarelto® (rivaroxaban) in combination with aspirin in patients with symptomatic peripheral artery disease (PAD) following lower-extremity revascularization, met its primary efficacy and primary safety endpoints: compared with aspirin alone, the combination therapy reduced the risk of major adverse limb and cardiovascular (CV) events by 15%, with similar rates of TIMI major bleeding.

Innovent Biologics’ PD-1 Inhibitor Tyvyt® Granted Orphan Drug Designation by the FDA for the Treatment of T-Cell Lymphoma

Recently, Tyvyt® (sintilimab injection), an innovative PD-1 inhibitor independently developed by Innovent Biologics, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of T-cell lymphoma. Tyvyt® (sintilimab injection) is an innovative biologic drug of international quality co-developed in China by Innovent Biologics and Eli Lilly and Company.

Pharming’s Ruconest Recommended for Approval by CHMP for Treatment of Hereditary Angioedema in Children Aged ≥2 Years

Recently, biopharmaceutical company Pharming Group announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of Ruconest (conestat alfa) for the treatment of acute angioedema attacks in pediatric patients aged ≥2 years with hereditary angioedema (HAE). The CHMP’s opinion will now be submitted to the European Commission (EC) for review, which typically renders a final decision within two months.

Yangshengtang and Xiamen University Jointly Developed Novel Anti-Tumor Drug Has Passed Phase I Clinical Trial Approval

On March 25, Xiamen University announced that a new generation of tumor immunotherapy drug, "Recombinant Human PD-1 Antibody Herpes Simplex Virus for Injection," jointly developed by Yangshengtang Co., Ltd. and the research team at Xiamen University, has received clinical trial approval from the National Medical Products Administration (NMPA) and is currently undergoing Phase I clinical trials. It is reported that this drug employs a novel therapeutic mechanism, combining oncolytic virus therapy with immune checkpoint antibodies to achieve synergistic treatment effects.

JAVELIN Ovarian 100: Avelumab Combined with Chemotherapy versus Chemotherapy Alone Shows No PFS Benefit in Previously Untreated Epithelial Ovarian Cancer

It is reported that the 51st Annual Meeting of the Society of Gynecologic Oncology (SGO), originally scheduled to be held in Toronto, Canada, from March 28 to 31, 2020, was canceled due to the impact of the COVID-19 pandemic. On March 28, the SGO website released the meeting abstracts and announced that online seminars would be held for certain educational topics. Among the abstracts published on the website, the international, multicenter, Phase III JAVELIN Ovarian 100 study showed that no progression-free survival (PFS) benefit was observed with the PD-L1 monoclonal antibody avelumab combined with chemotherapy versus chemotherapy alone in the treatment of newly diagnosed epithelial ovarian cancer.

AstraZeneca’s Farxiga (dapagliflozin) achieves milestone in Phase III trial, significantly reducing the risk of heart failure worsening and cardiovascular death

Recently, AstraZeneca announced new data from a subgroup analysis of the landmark Phase III DAPA-HF study for its glucose-lowering drug Farxiga (Chinese brand name: Andatang; generic name: dapagliflozin). The results showed that in patients with heart failure with reduced ejection fraction (HFrEF), Farxiga significantly reduced the incidence of the primary composite endpoint of worsening heart failure (HF) or cardiovascular (CV) death compared with placebo, regardless of background therapy (i.e., other medications used to treat heart failure) (16.3% vs. 21.2%; HR=0.74 [95% CI: 0.65–0.85], p<0.0001).

Bayer and Merck’s First-in-Class sGC Stimulator Vericiguat Significantly Reduces the Composite Risk of Heart Failure Hospitalization or Cardiovascular Death

Recently, Bayer and Merck & Co. jointly released detailed data from the Phase III VICTORIA trial (NCT02861534) evaluating vericiguat for the treatment of heart failure. VICTORIA is the first contemporary outcomes study specifically focused on patients with symptomatic chronic heart failure with reduced ejection fraction (<45%) who have experienced a worsening event. The results demonstrated that, when used in combination with standard heart failure therapies, vericiguat significantly reduced the risk of the composite endpoint of heart failure hospitalization or cardiovascular death compared with placebo in patients with chronic heart failure (ejection fraction <45%) following a worsening event.

Ping An of China Invests RMB 2.18 Billion in Japan’s Shionogi & Co., Acquiring a 2% Stake to Become the Seventh-Largest Shareholder

On March 30, 2020, Ping An Insurance announced that it had reached a strategic cooperation agreement with Shionogi & Co., Ltd. of Japan. Shionogi will sell 6.356 million treasury shares to Ping An Life Insurance, a subsidiary of Ping An Insurance, for a total transaction amount of JPY 33.53 billion (approximately RMB 2.18 billion). Upon completion of the transaction, Ping An Life Insurance will hold a 2% stake in Shionogi, becoming its seventh-largest shareholder. Meanwhile, both parties agreed to establish a joint venture in Hong Kong, China. The joint venture will initially focus on novel therapies for central nervous system disorders and will obtain exclusive distribution rights for two new drugs from Shionogi’s portfolio in Asian markets (excluding Japan).

Ampak USA Laboratory Receives CAP Accreditation

On March 30, 2020, Ampersand Biomedical Technology Co., Ltd., a company operating in both China and the United States with a focus on early cancer screening and detection, announced that its laboratory in San Jose, California, had received accreditation from the College of American Pathologists (“CAP”). As of June 30, 2019, Ampersand held 121 patents authorized in more than 20 countries and regions.

Daxing Pharmaceutical Base to Expand by 9 Square Kilometers, Building a RMB 100-Billion-Level "China Pharma Valley"

On March 26, the Daxing Biomedical Industry Base of Zhongguancun National Independent Innovation Demonstration Zone announced that it would expand its area by 9.1 square kilometers, incorporating the Jingnan Logistics Base and the Daxing Southeast Industrial Zone into its policy-covered region, thereby forming a 30-square-kilometer clustered development pattern. Additionally, it is projected that by 2025, the base will be built into a “China Pharmaceutical Valley” with an output value exceeding RMB 100 billion.

Mercer Explores Innovative Models in Commercial Health Insurance to Provide Novel Coverage for Malignant Tumor Patients

Recently, Mercer, a global leader in talent and risk consulting services, announced that its Health and Benefits team is actively driving innovation in commercial health insurance products. By developing single-disease health insurance models, the firm is exploring innovative coverage solutions for patients with malignant tumors. Currently, Mercer is collaborating with Roche China, a leader in the global biopharmaceutical industry, starting with breast cancer care. The partnership aims to understand the demand for cancer prevention and treatment medications in the Chinese market, further improve access to innovative drugs, and achieve mutual benefits for all stakeholders.

Xi'an Launches the Second Round of National Centralized Drug Procurement, with Selected Drug Prices Dropping by Another 25%

Recently, the Xi’an region completed the first cycle of the national centralized drug procurement and usage pilot program. Starting from 00:00 on March 25, the second cycle was officially launched. This second cycle of centralized procurement will last for 8.5 months and will be integrated with the province-wide expansion pilot of centralized volume-based drug procurement by December 10 this year. During this cycle, the scope of centralized volume-based drug procurement has been further expanded to cover all public medical institutions in the Xi’an area (including provincial-level public medical institutions), military medical institutions stationed in Xi’an, and some social medical institutions designated as medical insurance providers. Compared with the winning varieties from the “4+7” pilot, the prices of the 25 drugs selected in this round have decreased further on top of the average 52% price reduction achieved in the previous cycle, with an additional average decrease of 25%. Among them, eight drugs saw price reductions exceeding 50%.

Evergrande Health Discloses 2019 Performance Report: Revenue Reaches RMB 5.635 Billion, a Year-on-Year Increase of 79.88%

On March 30, Evergrande Health disclosed its 2019 annual performance report. During the reporting period, it achieved an operating revenue of RMB 5.635 billion, a year-on-year increase of 79.88%. The gross profit for the period was RMB 1.887 billion, a year-on-year increase of 64.8%. The Group’s gross profit amounted to RMB 1.887 billion, representing a 64.78% increase compared to the same period in 2018. The gross profit margin decreased from 36.55% in the same period of 2018 to 33.49% this year. The primary reason was the increased business volume of health and wellness spaces, which led to higher total revenue and consequently higher total profit. The slight decline in the gross profit margin associated with the newly added revenue from health and wellness spaces was attributable to variations in project locations.

GSK Announces the Launch of Its Stable-Stage COPD Treatment “Trelegy” on the Ali Health Platform

On March 30, 2020, GlaxoSmithKline (GSK) announced the exclusive launch of Trelegy® Ellipta®, the world’s first once-daily triple-combination inhalation therapy for stable chronic obstructive pulmonary disease (COPD), on the Ali Health platform. With the generic name Fluticasone Furoate/Umeclidinium/Vilanterol Inhalation Powder (100/62.5/25 mcg), this milestone leverages “Internet + Healthcare” technologies and online platform resources to further expand the accessibility of Trelegy® in the Chinese market, thereby meeting the medication and diagnostic and treatment needs of a broad population of COPD patients.

Cancer Discovery: HER2-Targeted Antibody-Drug Conjugates Demonstrate Promising Efficacy in the Treatment of Non-Small Cell Lung Cancer

Recently, Dr. Bob T. Li, an oncologist at Memorial Sloan Kettering Cancer Center (MSKCC), led a research team in evaluating the safety and clinical activity of the HER2-targeted antibody-drug conjugate Enhertu in patients with non-breast, non-gastric solid tumors exhibiting HER2 overexpression and/or HER2 gene mutations. The results of this Phase 1 clinical study demonstrated early promise for Enhertu in these patients, and the findings were published in Cancer Discovery.

Nano Energy: 3D-Printed Sensors Enable Breath Tests for Diabetes

Recently, a research team from the Department of Materials Science at Kiel University (CAU) and the Department of Biomedical Engineering at the Technical University of Moldova has developed a procedure for producing highly sensitive and energy-efficient sensors using 3D printing. In the specialized journal *Nano Energy*, the team explained that this simple and cost-effective production method is also suitable for industrial manufacturing. The sensors they demonstrated can accurately measure acetone vapor concentrations using specialized nanostructures. Since acetone levels in breath are correlated with blood glucose levels, the researchers aim to take a step forward by providing breath tests for diabetic patients as an alternative to daily finger-prick blood glucose monitoring.

《Stem Cell Reports》: New Model Reveals How HIV Affects Cognitive Function in the Brain

Recently, researchers from the Penn School of Dental Medicine, the Perelman School of Medicine, and the Children’s Hospital of Philadelphia established a human induced pluripotent stem cell (hiPSC)-based model and discovered that HIV infection enhances EIF2 signaling in microglia, astrocytes, and neurons. The study was published in the journal Stem Cell Reports.

BioRxiv: First Independent Validation Results Based on the MGI DNBSEQ-T7 Sequencer

Recently, researchers from South Korea’s Clinomics, the Korean Genome Center (KOGIC) under the Ulsan National Institute of Science and Technology, and other institutions released the first independent validation results based on MGI’s DNBSEQ-T7 sequencer on the preprint server bioRxiv. The researchers conducted a systematic comparison of seven different sequencing platforms from MGI and Illumina. By comparing sequencing statistics, alignment statistics, and variant statistics, they found that MGI and Illumina sequencing platforms were comparable in terms of sequencing quality, coverage uniformity, GC coverage, and variant accuracy. Consequently, they concluded that the MGI platform can be widely used in genomic research, with its cost being only about half that of the Illumina platform.

Kangdetang Chemical Cell Immunotherapy Published as Cover Article in ACS Central Science

Recently, Nokangde’s independently developed Sugar Cell immunotherapy was featured as the cover article in the renowned journal *ACS Central Science* on March 5, 2020. This further validates the application prospects of Sugar Cell immunotherapy in the treatment of hematologic malignancies and solid tumors, marking its recognition by the international mainstream academic community. It has been disclosed that Nokangde has completed in vitro cell model validation for Sugar Cell immunotherapy, as well as validation in animal models of subcutaneous and hematologic tumors. The results consistently demonstrated that Sugar Cell immunotherapy significantly inhibits CD22-positive tumor cells. Furthermore, collaborative research with hospitals has shown that Sugar Cell immunotherapy exerts a significant inhibitory effect on B cells with high CD22 expression isolated from lymphoma patients.