SARS-CoV-2 Median Incubation Period Confirmed at 4.75 Days, Estimated Fatality Rate at 3.06%, and Live Virus Isolated from Patient Stool Samples

State Key Laboratory of Respiratory Disease Team Detects Live SARS-CoV-2 in Patient Stool Samples

On February 13, Zhao Jincun, Deputy Director of the State Key Laboratory of Respiratory Disease, announced at a press conference on epidemic prevention and control held by the Information Office of the Guangdong Provincial People's Government that his team had isolated live coronavirus from a fecal sample collected from a critically ill patient at the Fifth Affiliated Hospital of Sun Yat-sen University, using a Biosafety Level 3 (P3) laboratory. This finding is of public health significance and can inform policy formulation. Zhao Jincun noted that this discovery was not incidental, as Academician Li Lanjuan’s team had made similar findings. The presence of live novel coronavirus in patients’ feces indicates potential new routes of SARS-CoV-2 transmission; however, further research is needed to determine whether it can cause human-to-human transmission. According to the official website of the State Key Laboratory of Respiratory Disease, Zhong Nanshan previously served as the laboratory’s director.

Analysis of Nearly 9,000 COVID-19 Cases: Median Incubation Period of 4.75 Days, Basic Reproduction Number (R0) Reaching 3.77, and Estimated Case Fatality Rate of 3.06%

Recently, the preprint server medRxiv published a latest analysis of COVID-19 epidemic data. The patient data analyzed were sourced from 30 provincial-level administrative regions across China, comprising 8,866 cases, including both confirmed and suspected cases. The study showed that the median incubation period of the novel coronavirus was 4.75 days, the basic reproduction number (R0) reached 3.77, the estimated case fatality rate was 3.06%, and elderly male patients constituted a high-risk group.

Sichuan’s “COVID-19 No. 1, No. 2, and No. 3” hospital preparations approved for use; 205 designated treatment hospitals authorized for inter-hospital transfer

On February 12, it was learned from the Sichuan Provincial Medical Products Administration that the administration, in conjunction with the Provincial Administration of Traditional Chinese Medicine, jointly issued a notice. During the epidemic period, the “Qingfei Jiedu Mixture (COVID-19 No. 1)” declared by the Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, and the “Yinqiao Huopo Antipyretic Mixture (COVID-19 No. 2)” and “Jingfang Huopo Detoxification Mixture (COVID-19 No. 3)” declared by the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine) are approved for direct dispensing and use at 205 designated hospitals for the treatment of novel coronavirus pneumonia in Sichuan Province, without the need to submit dispensing applications to the Sichuan Provincial Medical Products Administration. For non-designated hospitals in Sichuan Province applying for dispensing and use, the Sichuan Provincial Medical Products Administration will grant expedited approval.

Immunotherapy Company ALX Oncology Secures $105 Million in Series C Funding to Advance Phase 2 Clinical Trials for Solid Tumors and Hematologic Cancers

On February 13, 2020, immunotherapy company ALX Oncology (formerly Alexo Therapeutics) announced the completion of a $105 million Series C financing round to support the Phase 2 clinical development of its CD47 checkpoint inhibitor, ALX148, in combination with other anticancer therapies for the treatment of solid tumors and hematologic malignancies. Previously, the company had completed a $60 million financing round. This latest round builds upon the recently released Phase 1 clinical trial data evaluating ALX148 in combination with rituximab for patients with relapsed/refractory non-Hodgkin lymphoma (NHL). In this trial, the combination therapy achieved an objective response rate (ORR) of 43% in NHL patients, with a median progression-free survival (PFS) of 7.3 months.

Roche’s PD-L1 Approved in China for the Treatment of Small Cell Lung Cancer

On February 12, Roche’s atezolizumab (Tecentriq) received approval from the National Medical Products Administration (NMPA) for the treatment of small cell lung cancer (SCLC), with the official approval document issued. This marks the second PD-L1 monoclonal antibody approved for marketing in China, following AstraZeneca’s Imfinzi. Currently, eight PD-1/PD-L1 inhibitors have been approved for launch in China.

Qilu Pharmaceutical’s Capecitabine Tablets Become the First to Pass Consistency Evaluation

On February 10, Qilu Pharmaceutical’s capecitabine tablets (0.5 g and 0.15 g) passed the consistency evaluation, marking the first such approval in China. Capecitabine tablets are an antineoplastic agent indicated for adjuvant chemotherapy of colon cancer, primarily as monotherapy for patients with Dukes’ C stage disease who have undergone curative resection of the primary tumor and are suitable for treatment with fluoropyrimidine alone.

Xinhua Pharmaceutical’s Own-Brand Ibuprofen Tablets Gain Approval for Entry into the U.S. Market

Recently, Hualu Group’s subsidiary Xinhua Pharmaceutical’s ibuprofen tablets (ANDA202413) complied with the U.S. cGMP quality system requirements and passed FDA inspection with “zero deficiencies,” marking that Xinhua-brand ibuprofen tablets have obtained access to the U.S. market. It is reported that ibuprofen is among the clinical medications used in the treatment of pneumonia caused by novel coronavirus infection.

Zai Lab Secures Clinical Trial Approval for Five Anti-Cancer Drugs, Four of Which Are Not Yet Marketed in China

According to the latest data from the website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration, Zai Lab has obtained implicit approval for clinical trials in China for five drug candidates: the PD-1 monoclonal antibody INCMGA00012 injection, the HER2 monoclonal antibody margetuximab injection, the PD-1/LAG-3 bispecific antibody MGD013 injection, the kinase inhibitor alanturcib tablets, and the PARP inhibitor niraparib capsules. All five products were in-licensed by Zai Lab from other companies; with the exception of niraparib, the other four have not yet been marketed in China.

Otsuka Pharmaceutical’s Fixed-Dose Tablet ASTX727 (cedazuridine + decitabine) Receives FDA Priority Review

Recently, Astex Pharmaceuticals, a wholly owned subsidiary of the Japanese pharmaceutical company Otsuka Pharmaceutical, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ASTX727 (cedazuridine/decitabine [oral C-DEC]), an oral fixed-dose combination anticancer drug, and granted it Priority Review. The drug is indicated for the treatment of adult patients with previously untreated intermediate- and high-risk myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML). If approved, ASTX727 will become the first oral hypomethylating agent approved in the United States for the treatment of MDS and CMML.。 

Biopharmaceutical Company Deciphera Announces FDA Priority Review for KIT/PDGFRα Kinase Inhibitor Ripretinib

Recently, Deciphera, a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ripretinib, a broad-spectrum KIT and PDGFRα inhibitor, and granted it Priority Review. The drug is indicated for the treatment of patients with advanced gastrointestinal stromal tumor (GIST) who have previously received therapy with imatinib, sunitinib, and regorafenib. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2020, for this NDA.

Merck’s Keytruda Meets Primary PFS Endpoint in Pivotal Phase III Trial for Triple-Negative Breast Cancer

On February 12, Merck & Co. (MSD) announced that Keytruda (pembrolizumab) in combination with chemotherapy (nab-paclitaxel, paclitaxel, or gemcitabine/carboplatin) met the primary endpoint of progression-free survival (PFS) in the pivotal Phase 3 KEYNOTE-355 clinical trial evaluating first-line treatment for metastatic triple-negative breast cancer (mTNBC) with PD-L1 expression (Combined Positive Score [CPS] ≥10). Based on an interim analysis conducted by an independent Data Monitoring Committee (DMC), first-line treatment with Keytruda plus chemotherapy demonstrated a statistically and clinically significant improvement in PFS compared with chemotherapy alone.

Junshi Biosciences Initiates Phase I Clinical Study of PD-L1 Therapy for Advanced or Recurrent Solid Tumors

On February 12, Junshi Biosciences registered and initiated a domestic Phase I clinical trial of JS003, a humanized anti-PD-L1 monoclonal antibody independently developed by the company, to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) of JS003 in patients with previously treated advanced or recurrent solid tumors. The study plans to enroll 36 subjects. This is an open-label, non-randomized, single-arm trial. The primary endpoints are safety, tolerability, and dose-limiting toxicity (DLT) within 21 days after the first and last doses. Secondary endpoints include: the timing and incidence of anti-drug antibodies (ADA) against JS003; serum concentration and pharmacokinetic (PK) parameters of JS003; antitumor activity of JS003; receptor occupancy of JS003; and analysis of lymphocyte subsets.

Sanofi Restructures Management, Four Executives Depart

On February 12, Sanofi CEO Paul Hudson announced a restructuring of the company’s management team, with four executives set to depart: Ameet Nathwani, Chief Medical and Digital Officer; Dieter Weinand, Head of Primary Care; Dominique Carouge, Head of Business Transformation; and Kathleen Tregoning, Head of External Affairs. It remains unclear whether the “departures” will take effect immediately or occur over a transitional period.

Boehringer Ingelheim Invites Scientists to Submit Research Proposals on Novel Disease Indications for IL-1RAP Antibodies

On February 13, 2020, Boehringer Ingelheim’s opnMe platform shared a highly potent and selective human IL1RAP monoclonal antibody (mAb) against interleukin-1 receptor accessory protein. The company invited scientists worldwide to submit testable research proposals for evaluating this molecule in novel disease indications. A negative control antibody was also available to demonstrate the utility of this molecule in new therapeutic areas. BI-5041 is a humanized monoclonal IL1RAP antibody that blocks the interaction between IL1RAP and its primary co-receptors, thereby potently inhibiting signaling by IL-1 family cytokines. This compound will be provided free of charge in quantities sufficient for experimental needs, suitable for both in vitro assays and humanized in vivo models.

AlloVir Announces Viralym-M Granted Priority Medicines Status by the EMA

Recently, AlloVir, a T-cell immunotherapy company in late-stage clinical development, announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to Viralym-M (ALVR105), an allogeneic, off-the-shelf, multi-virus-specific T-cell therapy for the treatment of severe infections caused by BK virus, cytomegalovirus, human herpesvirus 6, Epstein-Barr virus, and/or adenovirus in recipients of allogeneic hematopoietic stem cell transplantation (HSCT).

BGI’s “0 PCR Whole Genome Sequencing (WGS)” Product Selected as One of the “Top Ten Innovative Products”

Recently, BGI’s “0 PCR Whole Genome Sequencing (WGS)” product, based on its proprietary DNBSEQ™ platform, was successfully selected as one of the “Top 10 Innovative Life Science Products of 2019” by Bioon. This product combines a PCR-free library preparation method that eliminates amplification errors with DNBSEQ™ sequencing technology that prevents the accumulation of copy errors, thereby achieving true PCR-free whole-genome library preparation and sequencing to restore the authentic genomic landscape. Compared with other platforms, this technology effectively avoids base mismatches and biases introduced by PCR amplification.

Johnson & Johnson Expands Collaboration with U.S. Government Agencies to Accelerate Development of Coronavirus Vaccine

Recently, Johnson & Johnson announced that its Janssen Pharmaceuticals has expanded its collaboration with the Biomedical Advanced Research and Development Authority (BARDA), under the U.S. Department of Health and Human Services (HHS), to further accelerate its investigational coronavirus vaccine program. At the end of last month, Johnson & Johnson announced its entry into the fight against the novel coronavirus (COVID-19). The company stated that it is mobilizing resources from Janssen Pharmaceuticals to launch multiple initiatives in response to the outbreak of the novel coronavirus. As part of these efforts, Janssen has begun developing a candidate vaccine against coronaviruses and is engaging in extensive close collaborations with global partners to screen its library of antiviral molecules, thereby accelerating the identification of compounds with antiviral activity against COVID-19.

Sihuan Pharmaceutical and Xidelong Pharmaceutical Forge Partnership in the Pharmaceutical Sector

On February 11, Sihuan Pharmaceutical Holdings Group Ltd. announced that it had entered into a framework cooperation agreement with the Indian pharmaceutical company Hetero (Hetero Drugs) in the pharmaceutical sector. The collaboration encompasses research and development, product registration, technology transfer, raw material supply, and close coordination in localized production and sales of drugs in the areas of cardiovascular and cerebrovascular diseases, central nervous system disorders, and anti-infectives—including those targeting the novel coronavirus (2019-nCoV)—with the aim of achieving mutual growth.

"Cancer Cell": Researchers Develop a Novel Method to Effectively Block Melanoma Metastasis

Recently, a research report published in the international journal Cancer Cell described a new method developed by scientists from the University of Valencia and other institutions to effectively block melanoma metastasis. In the article, researchers identified a specific genetic material that may prevent skin cancer cells from migrating to distant sites and forming metastases. This discovery paves the way for investigating novel cancer biomarkers, which could aid in the development of new anticancer therapies.