China's First Epothilone-Class Class 1 New Drug for Breast Cancer, Utidelone, Approved for Market Launch

[March 12, 2021 / Pharmaceutical News Brief] China’s first Class 1 innovative drug of the epothilone class for breast cancer approved for market launch; Liu Wentao resigns as director of China Resources Sanjiu; Xintai Pharmaceutical’s oxiracetam injection approved for market launch... Stay tuned with Sudushe for the latest daily updates on pharmaceutical and medical news!

Part 1 Policy Brief

National Healthcare Security Administration Issues Document: Hospitals Across the Country Begin Submitting Procurement Data for Orthopedic Consumables

On the 12th, a document regarding the submission of hospital procurement data for certain high-value medical consumables circulated within the industry. Local healthcare security administrations and centralized drug and medical consumable procurement agencies are required to extend the data collection for certain high-value orthopedic consumables—including artificial joints, spinal implants, and trauma devices—to healthcare institutions, building upon the earlier data collection conducted at the provincial platform level. (Sina Pharmaceutical News)

NMPA Releases Announcement on Registration of Medical Device Master Files on the 12th

On March 12, the National Medical Products Administration (NMPA) issued a notice titled “Announcement on Matters Concerning the Registration of Medical Device Master Files.” The announcement stipulates that it applies to the registration of master files referenced in applications for the registration, modification, and clinical trial approval of domestically produced Class III medical devices and imported Class II and Class III medical devices. Drug regulatory authorities of all provinces, autonomous regions, and municipalities directly under the Central Government may, based on local conditions, refer to this announcement to implement the registration of master files for domestically produced Class II medical devices. (National Medical Products Administration)

Chengdu Municipal Health Commission Launches Special Campaign Against "Illegal Medical Aesthetics"

On March 12, the Chengdu Municipal Health Commission organized a citywide special campaign targeting “illegal medical aesthetics.” As of 3:00 p.m. that day, 13 lifestyle beauty establishments were found on-site to be suspected of engaging in medical aesthetic activities. Zhou Qin, head of the Medical Health Law Enforcement Detachment under the Sichuan Provincial Health and Family Planning Supervision and Law Enforcement General Team, stated that any technical procedures in beauty services that involve breaking the skin or invading the body fall within the scope of medical aesthetics. She urged citizens to enhance their awareness and promptly file complaints or reports with relevant authorities if their rights and interests are infringed upon. (Cailianshe)

A Pharmacy Staff Member Was Sentenced to Four Years in Prison for Causing Death by Dispensing the Wrong Medication

On March 11, according to a report by the Xijiang Metropolitan Daily, the Changzhou District People’s Court in Wuzhou City recently issued a first-instance verdict in a case involving a pharmacy owner charged with negligent homicide. The defendant, Qin, mistakenly prescribed the herbal remedy “Wushuiteng” (Stephania vine), which was actually Gelsemium elegans (heartbreak grass), to the victim, Zhao, ultimately causing his death. After deliberation, the Changzhou District Court held that Qin’s actions violated criminal law and constituted the crime of negligent homicide, sentencing him to four years’ imprisonment. (Pharmacy Manager)

Part 2 Industry and Economics Observation

CR Sanjiu Director Liu Wentao Resigns

On March 12, China Resources Sanjiu announced that it had received the resignation letter submitted by Director Liu Wentao. Due to changes in his work arrangements, Mr. Liu has requested to resign from his positions as a director of the Seventh Board of Directors and as a member of the Remuneration and Appraisal Committee of the Board. Following his resignation, Mr. Liu will no longer hold any position within the company. (Announcement by China Resources Sanjiu)

Liang Xu Serves as Vice President of Scientific and Medical Affairs at Brii Biosciences

On March 12, Brii Biosciences announced the appointment of Mr. Liang Xu as Vice President of Scientific and Medical Affairs and Ms. Ji Fengyuan as Vice President of Government Affairs. Both executives will be based in Beijing. (PharmCube)

Cao Shaohua Appointed as New Head of Organon’s Women’s Health Business Unit in China

Today, Shi Wang, Head of Organon China, announced an appointment to employees: Cao Shaohua has joined Organon China effective immediately as Head of the Women’s Health Business Unit and has become a member of Organon China’s Senior Leadership Team. (Pharmaceutical Representative)

InnoCare Pharma Plans to List on the STAR Market

On March 11, InnoCare Pharma announced that its board of directors had resolved to issue RMB-denominated shares and list on the STAR Market of the Shanghai Stock Exchange. It is understood that, in addition to orelabrutinib, a BTK inhibitor already approved for marketing, InnoCare Pharma has independently developed more than 10 new drug candidates, covering areas such as hematologic malignancies, solid tumors, and autoimmune diseases. (Medical Observation)

Chuangxin International Completes Nearly RMB 100 Million in Series A Financing

Recently, Chuangxin International announced the completion of its Series A financing round, raising nearly RMB 100 million, led by Qudao Asset. According to reports, the funds will primarily be used to advance the research and development upgrade and industrialization of organoids. (Arterial Network)

Luqi Biologics Completes RMB 100 Million Series A Financing

VBDN has learned that Luqi Bio recently announced the completion of its RMB 100 million Series A financing round. The round was led by Tianhui Capital, with participation from Taiyu Investment and Fuhui Venture Capital. Hygeia Capital served as the exclusive financial advisor for this financing round. The funds will primarily be used to advance the Investigational New Drug (IND) application and clinical trials for its inhaled nanobody-based asthma therapeutic, as well as to support the development of several other pipeline projects. (VBDN)

Part 3 Pharmaceutical News and Medical Updates

BNT162b2 Demonstrates 94% Efficacy in Preventing Asymptomatic Infection

Today, Pfizer, BioNTech, and the Israeli Ministry of Health jointly announced that real-world data indicate the BNT162b2 COVID-19 vaccine, co-developed by Pfizer and BioNTech, is up to 97% effective in preventing symptomatic COVID-19 and 94% effective in preventing asymptomatic infection. (WuXi AppTec)

Lee's Pharmaceutical Anti-PD-L1 Monoclonal Antibody Approved for Phase III Clinical Trial

Recently, Lee’s Pharmaceutical Holdings Limited announced that its subsidiary, China Cancer Healthcare, has received approval from the National Medical Products Administration (NMPA) for its clinical trial application to conduct a multicenter, randomized, double-blind, parallel-group Phase III clinical trial of Socazolimab in combination with chemotherapy as first-line treatment for extensive-stage small cell lung cancer. (Announcement by Lee’s Pharmaceutical Holdings Limited)

Roche’s Actemra Combined with Remdesivir Fails in Phase III Clinical Trial for Severe COVID-19 Patients

On March 10, Genentech, a member of the Roche Group, announced that the Phase III REMDACTA study evaluating the anti-inflammatory drug Actemra in combination with Veklury for the treatment of patients with severe COVID-19 pneumonia failed to meet its primary and key secondary endpoints. According to the report, by Day 28 of the trial, the Actemra plus Veklury group showed no improvement in length of hospital stay compared to the placebo plus Veklury group. Furthermore, the study did not meet its key secondary endpoints. (Sina Medical News)

GlaxoSmithKline/Vir Biotechnology Antibody Therapy Phase 3 Clinical Trial Terminated Early

Today, Vir Biotechnology and GlaxoSmithKline jointly announced that, based on positive interim analysis results of their co-developed neutralizing antibody therapy VIR-7831, the independent data monitoring committee recommended early termination of the Phase 3 clinical trial of VIR-7831 for the treatment of high-risk COVID-19 patients. In this clinical trial, a total of 583 patients received either VIR-7831 monotherapy or placebo. These patients had a threefold higher risk of hospitalization and a twofold higher risk of death compared to the average. (WuXi AppTec)

KRAS Inhibitors Gain New Contender: Eli Lilly’s Innovative Therapy Set to Launch Clinical Trials

Eli Lilly and Company recently announced that it will present preclinical data for its next-generation KRAS G12C-specific inhibitor, LY3537982, at the AACR Annual Meeting in April this year. Based on positive preclinical results, the company plans to initiate Phase 1 clinical trials this year to evaluate the safety and potential efficacy of this candidate drug. (WuXi AppTec)

EU Approves First Single-Dose COVID-19 Vaccine

On March 12, the European Medicines Agency (EMA) announced on the 11th its assessment results for a COVID-19 vaccine developed by Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, concluding that it demonstrates favorable efficacy and safety. On the same day, based on the EMA’s recommendation, the European Commission granted conditional marketing authorization for this vaccine in the European Union. This marks the fourth COVID-19 vaccine approved in the EU and the first single-dose COVID-19 vaccine, indicated for individuals aged 18 years and older. (Cailianshe)

Lilly’s RET Inhibitor Retsevmo Approved in the UK for Advanced Lung/Thyroid Cancer

On March 11, according to foreign media reports, the UK Medicines and Healthcare products Regulatory Agency granted conditional marketing authorization for Eli Lilly’s Retsevmo for the treatment of advanced RET fusion-positive lung cancer and thyroid cancer. Specifically, the authorization includes Retsevmo as the sole treatment option for patients with advanced RET fusion-positive non-small cell lung cancer who require systemic therapy prior to receiving immunotherapy and/or platinum-based chemotherapy. (Sina Medical News)

AstraZeneca’s Targeted Drug Tagrisso Approved in India

AstraZeneca India Announces Approval of Targeted Anti-Cancer Drug Tagrisso in India: For Adjuvant Treatment of Patients with Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations After Complete Tumor Resection (Bioon)

Novartis' Kymriah Approved by Singapore HSA

Novartis recently announced that the Health Sciences Authority of Singapore has approved Kymriah, marking it as the first commercialized chimeric antigen receptor T-cell (CAR-T) therapy in Singapore. Kymriah is a CD19-directed, genetically modified autologous T-cell immunotherapy indicated for the treatment of two types of B-cell malignancies. (Bioon)

China’s First Class 1 Novel Epithilone Drug for Breast Cancer, Utidelone, Approved for Market Launch

On March 12, the NMPA website showed that Huahao Zhongtian’s Class 1 new drug, utidelone, received a drug approval number. In June 2018, the marketing application for this drug for the treatment of patients with metastatic or locally advanced breast cancer was included in the priority review by the Center for Drug Evaluation. The acceptance number associated with the newly issued approval number is consistent with the original registration acceptance number, indicating that utidelone has been officially approved in China for the treatment of breast cancer. (Jike Yaowen)

Xintai Pharmaceutical’s Oxiracetam Injection Approved for Market Launch

On March 11, the NMPA website announced that Xintai Pharmaceutical’s Oxiracetam Injection had been approved for market launch. It is understood that Oxiracetam Injection is an analog of Piracetam and can improve memory and learning functions in patients with senile dementia and memory disorders. It is indicated for the treatment of brain injuries and associated neurological deficits, as well as memory and cognitive impairments. (Menet)

Hengrui Medicine: SHR-1707 Injection Approved for Clinical Trials

On March 12, Jiangsu Hengrui Medicine Co., Ltd. announced that its subsidiary had recently received the “Notice of Approval for Drug Clinical Trials” issued by the National Medical Products Administration (NMPA) for SHR-1707 injection, and clinical trials will be initiated in the near future. SHR-1707 injection can inhibit the assembly of β-amyloid plaques or activate microglia to phagocytose various forms of Aβ, thereby reducing Aβ levels in the brains of patients with Alzheimer’s disease (AD), ultimately slowing cognitive decline and controlling disease progression. (Announcement from Jiangsu Hengrui Medicine Co., Ltd.)

Fuan Pharmaceutical's Escitalopram Oxalate Tablets Enter Administrative Approval Phase

Recently, Fuan Pharmaceutical’s application for marketing approval of Escitalopram Oxalate Tablets, filed under Category 4 for generic drugs, has entered the administrative review phase, with approval for production expected imminently. Escitalopram Oxalate Tablets are the single dextrorotatory optical isomer of citalopram, a bicyclic hydrogenated phthalane derivative, and are indicated for the treatment of depression and panic disorder. Compared with other antidepressants in the same class, Escitalopram Oxalate Tablets demonstrate superior efficacy and tolerability, making them a first-line medication for the treatment of depression. (Menet)

Aosaikang's "Eltrombopag Olamine Tablets" Are About to Be Approved

Recently, the marketing application for Jiangsu Aosaikang’s Class 4 generic drug, Eltrombopag Olamine Tablets, has been updated to “under review,” with approval expected this month. Previously, Eltrombopag Olamine Tablets were indicated for the treatment of thrombocytopenia in patients with chronic primary immune thrombocytopenia who had an insufficient response to corticosteroids or immunoglobulins, or who had undergone splenectomy. (CPhl Pharma Online)

Aosaikang's Pemetrexed Disodium for Injection Passes the Generic Drug Consistency Evaluation

On March 12, Ask Pharm announced that its wholly-owned subsidiary, Jiangsu Ask Pharmaceutical, recently received the "Notice of Approval for Supplementary Drug Application" for Pemetrexed Disodium for Injection, approved by the National Medical Products Administration (NMPA), signifying that the drug has passed the consistency evaluation. It is understood that the Pemetrexed Disodium for Injection developed by our company is indicated for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) or unresectable malignant pleural mesothelioma; or as monotherapy for patients with locally advanced or metastatic non-squamous NSCLC who have experienced disease progression following first-line chemotherapy. (Ask Pharm Announcement)

CSPC’s Entecavir Tablets and Ceftriaxone Sodium for Injection Successively Pass Consistency Evaluation

According to the latest updates on the NMPA website, CSPC Pharmaceutical Group’s entecavir tablets have been approved for production and are considered to have passed the consistency evaluation. Meanwhile, ceftriaxone sodium for injection has also passed the consistency evaluation. Entecavir, a guanosine nucleoside analog, inhibits the reverse transcriptase of the hepatitis B virus and has been recommended as a first-line antiviral drug in multiple guidelines for the diagnosis and treatment of hepatitis B. Ceftriaxone sodium exhibits potent antibacterial activity against the vast majority of Gram-negative and Gram-positive bacteria. (Menet Network)

7,567 People in South Korea Reported Suspected Adverse Reactions After Receiving AstraZeneca Vaccine

On March 12, according to Yonhap News Agency, South Korea’s COVID-19 Vaccination Promotion Task Force reported that since the start of the country’s COVID-19 vaccination campaign, a total of 7,648 cases of suspected adverse reactions following immunization had been reported. Of these, 7,567 cases were associated with the AstraZeneca vaccine, accounting for 98.9% of the total, while the remaining 81 cases were linked to the Pfizer vaccine. (Cailian Press)