Pfizer's CD22-Targeted Antibody-Drug Conjugate Besponsa Granted Priority Review in China for Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

China Has Disposed of a Cumulative Total of 136,000 Tonnes of Medical Waste Related to the COVID-19 Pandemic

On March 10, according to the Ministry of Ecology and Environment of China, a total of 136,000 metric tons of medical waste were disposed of nationwide from January 20 to March 7, with pandemic-related medical waste basically cleared on a “daily production, daily clearance” basis. Zhao Qunying, Director of the Emergency Response Office of the Ministry of Ecology and Environment, stated that the ministry is closely monitoring the operation of medical waste disposal facilities. Currently, there are 487 centralized medical waste disposal entities across 358 cities in all 31 provinces, autonomous regions, municipalities directly under the central government, and the Xinjiang Production and Construction Corps. The average daily actual disposal capacity stands at 6,022 metric tons, representing an increase of 1,119.2 metric tons per day, or 23%, compared with the pre-January 20 average daily disposal capacity of 4,902.8 metric tons.

Boehringer Ingelheim’s Ofev Receives FDA Approval for Third Indication: Treatment of Patients with Progressive Fibrosing Interstitial Lung Disease

On March 10, Boehringer Ingelheim announced that the U.S. FDA had approved Ofev (nintedanib) for the treatment of patients with chronic progressive fibrosing interstitial lung diseases (ILDs). This marks the third indication for which Ofev has received FDA approval, and it is the first therapy approved by the FDA for progressive chronic fibrosing ILDs. Many pulmonary conditions can progress to chronic progressive fibrosing ILD, including autoimmune ILDs, unclassifiable ILDs, chronic hypersensitivity pneumonitis, sarcoidosis, myositis, Sjögren's syndrome, coal worker’s pneumoconiosis, and idiopathic interstitial pneumonias.

Hengrui Medicine’s Class 1 New Drug SHR8008 Capsules Clinical Trial Application Accepted by CDE

On March 9, the Center for Drug Evaluation (CDE) accepted the clinical trial application for SHR8008 capsules, a Class 1 innovative drug submitted by Hengrui Medicine. This agent is a novel oral antifungal drug that Hengrui licensed from Mycovia Pharmaceuticals in June 2019 for $110 million. SHR8008 (VT-1161), developed by Mycovia, is a novel oral small-molecule selective fungal CYP51 inhibitor, demonstrating significantly greater selectivity for fungal CYP51 than currently available azole antifungals.

Pfizer’s CD22-Targeted Antibody-Drug Conjugate Besponsa Proposed for Priority Review in China

On March 9, the official website of the Center for Drug Evaluation (CDE) indicated that Pfizer’s marketing application in China for inotuzumab ozogamicin for injection was proposed for inclusion in the priority review program under Category I(3), which covers innovative drugs with significant therapeutic advantages. Inotuzumab ozogamicin is the first antibody-drug conjugate targeting CD22, indicated for the treatment of adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia. The drug was initially approved for marketing in the European Union on June 28, 2017, and subsequently received FDA approval on August 17, 2017, under the brand name Besponsa.

Pumice Biologics’ PD-L1 Bispecific Antibody Approved for Clinical Trials

On March 9, the official website of the Center for Drug Evaluation (CDE) announced that PM8001, a humanized bispecific antibody developed by Biotheus Inc. targeting two tumor-associated antigens, including programmed death-ligand 1 (PD-L1), has recently received an Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA). The company plans to conduct clinical studies in advanced tumors, such as lung cancer. PM8001 is based on single-domain antibodies characterized by low molecular weight and high stability, and it simultaneously targets two tumor-associated antigens, including PD-L1, thereby enhancing anti-tumor activity and therapeutic efficacy.

Northeast Pharmaceutical's Vitamin B6 Tablets Pass the Generic Drug Consistency Evaluation

On March 10, Northeast Pharmaceutical Group announced that it had received the "Approval for Supplementary Drug Application" (Approval No.: 2020B02415) issued by the National Medical Products Administration (NMPA) for its Vitamin B6 Tablets, indicating that the product has passed the consistency evaluation of quality and efficacy for generic drugs. The announcement stated that the generic Vitamin B6 Tablets developed by Northeast Pharmaceutical are primarily indicated for the prevention and treatment of vitamin B6 deficiency.

Guangji Pharmaceutical’s Vitamin B6 Tablets Pass Consistency Evaluation

On March 9, Guangji Pharmaceutical issued an announcement stating that its product, Vitamin B6 Tablets, has passed the Consistency Evaluation of Quality and Efficacy for Generic Drugs. This medication is indicated for the prevention and treatment of vitamin B6 deficiency, such as seborrheic dermatitis and cheilitis, and may also be used to alleviate nausea and vomiting during pregnancy.

Hailing Pharmaceutical's Omeprazole Enteric-coated Capsules Pass the Generic Drug Consistency Evaluation

On March 9, Changjiang Runfa Health Industry Co., Ltd. issued a corporate announcement stating that its second-tier subsidiary, Hainan Hailing Chemical Pharmaceutical Co., Ltd., recently received the “Approval for Supplementary Drug Application” for Omeprazole Enteric-coated Capsules from the National Medical Products Administration (NMPA). This product has passed the consistency evaluation of quality and efficacy for generic drugs. Omeprazole Enteric-coated Capsules were developed by AstraZeneca and represent the first proton pump inhibitor (PPI) to be marketed. It is clinically indicated for the treatment of gastric and duodenal ulcers, reflux esophagitis, and Zollinger-Ellison syndrome.

Pharmaceutical Company Karyopharm Announces That Eysuvis Met Primary Endpoint in Phase 3 Clinical Trial for Dry Eye Disease

On March 10, Kala Pharmaceuticals announced that its Phase 3 clinical trial STRIDE 3, evaluating Eysuvis (KPI-121) for the treatment of dry eye disease (DED), met both primary and secondary endpoints. The press release stated that the company expects to resubmit the New Drug Application (NDA) for Eysuvis in the second quarter of this year based on the positive data from the trial, with a response from the U.S. FDA anticipated by year-end. Eysuvis is a novel nanoparticle formulation of loteprednol etabonate that leverages Kala’s proprietary mucus-penetrating particle (MPP) technology to enhance targeted penetration into ocular tissues.

Bristol Myers Squibb Announces Phase III Clinical Trial Failure of Empliciti-Based Three-Drug Regimen (ERd) for Multiple Myeloma

Recently, Bristol Myers Squibb (BMS) announced the top-line results of the Phase III ELOQUENT-1 trial. This randomized, open-label study evaluated the efficacy and safety of the three-drug regimen Empliciti (elotuzumab) plus Revlimid (lenalidomide) and low-dose dexamethasone (ERd) versus the two-drug regimen of lenalidomide plus low-dose dexamethasone (Rd) in patients with newly diagnosed, previously untreated multiple myeloma (MM) who were ineligible for transplantation. The results showed that in the final analysis, the ERd regimen did not demonstrate a statistically significant improvement in progression-free survival (PFS) compared with the Rd regimen, failing to meet the study’s primary endpoint.

ViiV Healthcare Announces Long-Acting HIV Combination Therapy Meets Phase 3 Clinical Endpoints

On March 10, ViiV Healthcare, a company specializing in HIV treatment and care, announced that its long-acting innovative two-drug combination therapy for HIV met the primary endpoint in the Phase III ATLAS-2M clinical trial. This regimen consists of cabotegravir, developed by ViiV Healthcare, and rilpivirine, developed by Janssen. The trial results demonstrated that, after 48 weeks of treatment, administering this two-drug combination every eight weeks was non-inferior to the every-four-weeks regimen in achieving viral suppression among adults with HIV-1 infection.

Amgen’s KRAS G12C Inhibitor AMG 510 Submits Clinical Trial Application in China

On March 9, the Center for Drug Evaluation (CDE) accepted Amgen’s clinical trial application for AMG 510. AMG 510 is the first oral, selective, reversible inhibitor targeting KRAS G12C. Phase I clinical results of AMG 510 in the treatment of solid tumors, presented by Amgen at the ESMO 2019 Congress, showed that among 12 patients with colorectal cancer treated with AMG 510 (960 mg/day), one achieved a partial response and ten achieved stable disease, resulting in a disease control rate of 92%. Among 13 patients with non-small cell lung cancer treated with AMG 510 (960 mg/day), seven achieved a partial response and six achieved stable disease, yielding a disease control rate of 100%. Of two patients with appendiceal cancer, one achieved a partial response and one achieved stable disease.

RedHill Biopharma’s Triple-Capsule Talicia Launched in the U.S. for the Treatment of Helicobacter pylori Infection

Recently, biopharmaceutical company RedHill Biopharma announced the launch of Talicia (omeprazole magnesium/amoxicillin/rifabutin, 10 mg/250 mg/12.5 mg) delayed-release capsules in the U.S. market. The drug was approved by the U.S. FDA in early November 2019 for the treatment of Helicobacter pylori (H. pylori) infection in adults. Talicia offers a new and effective therapeutic option and is poised to become a new first-line standard-of-care medication for the treatment of H. pylori infection.

NICE Rejects Sanofi/Regeneron’s Dupixent for Severe Asthma

Recently, the UK’s National Institute for Health and Care Excellence (NICE) announced that it does not recommend Dupixent for the treatment of severe asthma. NICE stated that there is a lack of head-to-head comparative trial data between Dupixent and other asthma medications available on the market, including GlaxoSmithKline’s Nucala, Teva’s Cinqair, and AstraZeneca’s Fasenra. Furthermore, NICE determined that the drug does not meet cost-effectiveness criteria, leading to its decision against recommending Dupixent for severe asthma treatment. NICE noted that Dupixent is currently listed as a routine medication by NHS England for the treatment of severe atopic dermatitis or eczema, with two pre-filled syringes priced at £1,264.89, subject to confidential discounts.

Study Shows: Molecular Testing-Guided Precision Therapy Can Reduce the Risk of Death by More Than Half in Patients with Advanced Pancreatic Cancer

Recently, The Lancet Oncology published a real-world study led by the MD Anderson Cancer Center, a top global cancer institution, indicating that precision therapy based on molecular testing reduces the risk of death in patients with advanced pancreatic cancer by more than half. This study provides strong evidence that pancreatic cancer patients should undergo genetic testing, and that treatments guided by molecular features such as oncogenic mutations and DDR mutations warrant further prospective evaluation.

*Nat Cell Bio*: Breast cancer cells may alter their metabolic strategies to facilitate metastasis

Recently, a research report published in the international journal Nature Cell Biology by scientists from institutions including the University of California suggests that new strategies may be developed to prevent cancer cells from spreading to other organs in the body, thereby effectively reducing mortality rates among breast cancer patients. The researchers indicated that breast cancer cells switch their metabolic strategy to facilitate metastasis; rather than relying on glucose for energy, they engage in limited mitochondrial metabolism.