NMPA Grants Emergency Approval to Four SARS-CoV-2 Diagnostic Products; Xilio Therapeutics Raises Over $100 Million in Series B Financing

NMPA Grants Emergency Approval for Four Novel Coronavirus Testing Products from Three Companies

Recently, the National Medical Products Administration (NMPA) granted emergency approval for four novel coronavirus detection products from three companies, including two chemiluminescence-based antibody detection reagents and two fluorescent PCR-based nucleic acid detection reagents. This move further diversifies the methods for detecting the novel coronavirus, expands the supply of testing reagents, and fully supports the needs of epidemic prevention and control. To date, a total of 10 nucleic acid detection reagents and 4 antibody detection reagents for the novel coronavirus have been approved.

BGI Group Has Completed the Production of 1.3 Million COVID-19 Nucleic Acid Test Kits

On March 3, BGI Group announced that as of 24:00 on March 2, it had cumulatively produced novel coronavirus nucleic acid test kits for 1.3 million people. Currently, the supply of novel coronavirus nucleic acid test kits is ample.

National Health Commission: Prioritize Safe Blood Supply to Ensure Clinical Medical Treatment

On March 2, the Bureau of Medical Administration and Hospital Management under the National Health Commission issued the “Notice on Further Implementing Requirements for Scientific Prevention and Control, Targeted Measures, and Zoned and Graded Management to Ensure Blood Supply During the Epidemic Period” on its official website. The Notice requires the implementation of zoned and graded management and the improvement of blood supply assurance strategies. Provincial-level joint prevention and control mechanisms (leading groups or command centers) for responding to the novel coronavirus pneumonia epidemic shall earnestly implement differentiated management requirements based on zones and grades, and deploy and implement blood supply assurance in tandem with the restoration of routine medical services.

Biotech Company Xilio Completes Over $100 Million in Series B Funding to Advance Clinical Development of Its Drug Candidates

On March 3, biotechnology company Xilio Therapeutics announced the completion of a Series B financing round exceeding $100 million. The round was led by Takeda Ventures, with participation from other new and existing investors. The proceeds will further advance the clinical development of its drug candidates XTX201 and XTX101, while expanding its pipeline of selective tumor-targeted cytokines.

Biotech Firm Immunocore Completes $130 Million Series B Funding to Expand Its Innovative Technology Platform

On March 2 (local time), biotechnology company Immunocore announced the completion of a $130 million Series B financing round. The round was led by General Atlantic, with participation from WuXi AppTec Venture Fund, CCB International, JDRF T1D Fund, Rock Springs Capital, and Hongling Capital, among others. The proceeds will be used to expand its innovative technology platform and advance the development of its pipeline products.

Takeda Pharmaceutical Sells Non-Core Assets to Hypera Pharma for $940 Million

On March 1, Takeda Pharmaceutical announced that it had agreed to sell 18 branded prescription and consumer healthcare products in the Latin American market to Hypera Pharma for $825 million. Meanwhile, Takeda relocated its U.S. operations from Chicago to the Greater Boston area and sold its former headquarters for $115 million. Key drugs included in the sale agreement with Hypera are the analgesic Neosaldina, Nesina (a DPP-4 inhibitor for type 2 diabetes), and the over-the-counter medication Dramin.

FDA Approves Sanofi’s CD38 Antibody Sarclisa for the Treatment of Multiple Myeloma

On March 2, the FDA announced the approval of Sanofi’s CD38 antibody Sarclisa (isatuximab-irfc) for marketing, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma (MM). These patients must have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

Hengrui Medicine’s Apatinib Mesylate Tablets Approved for Clinical Trials

On March 2, the official website of the Center for Drug Evaluation (CDE) announced that Hengrui Medicine’s apatinib mesylate tablets had been approved for clinical trials. The approved trial involves the combination of apatinib mesylate tablets with camrelizumab for injection as a first-line treatment for patients with recurrent or advanced non-small cell lung cancer (NSCLC) who are PD-L1 positive (TPS ≥1%) and do not harbor EGFR/ALK genetic mutations.

Hansen Pharmaceutical’s Captopril Tablets Pass Generic Drug Consistency Evaluation

On March 2, Hansen Pharmaceutical announced that the company had recently received the "Approval for Supplementary Drug Application" for its chemical drug, Captopril Tablets, issued by the National Medical Products Administration (NMPA). The drug has passed the consistency evaluation for generic drugs. Captopril Tablets are competitive angiotensin-converting enzyme (ACE) inhibitors, with clinical indications for hypertension and heart failure.

Hongri Pharmaceutical’s Moxifloxacin Hydrochloride and Sodium Chloride Injection Approved for Market Launch

On March 2, Tianjin Chase Sun Pharmaceutical issued an announcement stating that its Moxifloxacin Hydrochloride and Sodium Chloride Injection, submitted under the new Class 4 regulatory pathway, has been approved for market launch and is deemed to have passed the consistency evaluation. Moxifloxacin Hydrochloride and Sodium Chloride Injection is indicated for the treatment of the following infections caused by susceptible bacteria in adults (≥18 years of age), such as: acute bacterial sinusitis, acute exacerbations of chronic bronchitis, community-acquired pneumonia; uncomplicated skin and skin structure infections; complicated skin and skin structure infections; complicated intra-abdominal infections; plague, etc.

Merck’s Erbitux Approved for New Indication in China: First-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Recently, German pharmaceutical giant Merck KGaA announced that the National Medical Products Administration (NMPA) of China has approved Erbitux (cetuximab), in combination with platinum-based chemotherapy and fluorouracil, for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).

MorphoSys’ CD19 Monoclonal Antibody Therapy Granted FDA Priority Review

On March 2, pharmaceutical company MorphoSys announced that the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for the combination of tafasitamab and lenalidomide for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), while also granting it Priority Review status. A response is expected by August 30 this year.

Hengrui Medicine's Camrelizumab for Injection Approved for Clinical Trials

On March 2, the CDE website announced that Hengrui Medicine’s camrelizumab for injection had been approved for clinical trials. The newly approved trial investigates camrelizumab for injection, either in combination with apatinib or as monotherapy, as first-line treatment for recurrent or advanced non-small cell lung cancer (NSCLC) with positive PD-L1 expression.

Pharmaceutical Company SELLAS Life Sciences Announces Positive Data for Galinpepimut-S in the Treatment of AML

On March 2, biopharmaceutical company SELLAS Life Sciences announced the final follow-up data from its Phase I/II study evaluating the novel cancer vaccine galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) in second complete remission (CR2). The data showed that, with a median follow-up of 30.8 months, the median overall survival (OS) for AML-CR2 patients treated with GPS was 21.0 months, compared to 5.4 months for those receiving best standard of care, with a statistically significant difference between the groups (p < 0.02).

Antengene’s Selinexor Combination Therapy for Multiple Myeloma Meets Primary Endpoint in Phase III Clinical Trial

On March 3, Antengene announced that the Phase III BOSTON study met its primary endpoint of progression-free survival (PFS) when comparing the selinexor (XPOVIO®) in combination with bortezomib and low-dose dexamethasone (SVd) regimen versus the bortezomib and low-dose dexamethasone (Vd) regimen in patients with relapsed or refractory multiple myeloma who had received 1–3 prior anti-myeloma therapies. The median PFS was 13.93 months in the SVd group compared with 9.46 months in the Vd group, representing a median PFS extension of 4.47 months (47%).

Zhenbaodao Pharmaceutical Partners with Indian Pharma Company BE

On March 2, Heilongjiang Zhenbaodao Pharmaceutical announced that it had signed a Supply Agreement with the Indian pharmaceutical company BIOLOGICAL E. LTD. Under the agreement, BIOLOGICAL E. LTD. has designated Zhenbaodao as the exclusive distributor for the marketing, sales, and distribution in China of its Daptomycin for Injection (500mg). According to the terms, Zhenbaodao will pay BIOLOGICAL E. LTD. a licensing fee of $100,000 for Daptomycin for Injection (500mg), payable upon achievement of milestones. Although the financial scale of this collaboration is modest, it represents a strategic trial partnership for both BIOLOGICAL E. LTD. and Zhenbaodao.