Shi Wang Appointed as Head of Sanofi China

[June 22, 2022/Medical News at a Glance] Shi Wang to become the head of Sanofi China; Shenzhou Cell: Subsidiary’s recombinant COVID-19 vaccine Phase I/II clinical study achieves positive results... Daily fresh pharmaceutical news and medical updates, Speed Reading Society keeps you informed!

Policy Brief

China Proposes to Ban Third-Party Platforms from Directly Participating in Online Drug Sales

Recently, the public consultation period for the "Regulation on the Implementation of the Drug Administration Law of the People's Republic of China (Revised Draft for Soliciting Opinions)" issued by NMPA has officially ended. As the scale of the pharmaceutical retail market via third-party platforms continues to grow, the state will further clarify related management obligations. For instance, the newly added Article 83 explicitly stipulates: Third-party platform providers are not allowed to directly engage in online drug sales activities. (NMPA)

SASAC: Reviewed and Approved the Optimized Plan to Support High-Quality Development of State-Owned Enterprises' Medical Institutions

The Party Committee of the State-owned Assets Supervision and Administration Commission (SASAC) of the State Council has recently reviewed and approved a plan to optimize support for high-quality development of medical institutions run by state-owned enterprises. In the near future, it will carry out the approval process together with relevant departments. It is understood that state-owned enterprises mainly engaged in healthcare will receive policy support in areas such as inclusion in local planning, implementation of funding, hospital grading, professional title evaluation, and scientific research project applications, enjoying the same treatment as government-run medical institutions. (SASAC)

China's National Health Commission: Increase the Intensity of Spot Checks on Medical Institutions Providing Medical Aesthetics and Medical Testing Services

On June 22, the National Health Commission of China issued the 2022 National Random Supervision and Inspection Plan. The inspection content includes: the management of vaccination by medical and health institutions, with a focus on the receipt, storage, and administration of the COVID-19 vaccine; the reporting of infectious disease outbreaks, epidemic control, implementation of disinfection and isolation measures, medical waste management, and biosafety management of pathogenic microorganism laboratories in medical and health institutions. (National Health Commission of China)

CDE Releases Draft for Comment on New Drug Clinical Development for Chronic Lymphocytic Leukemia

On June 20, the CDE released the "Technical Guiding Principles for Clinical Development of New Drugs for Chronic Lymphocytic Leukemia (Draft for Comments)" to solicit opinions and suggestions from all sectors of society. The deadline for comments is one month from the date of release. (CDE)

Industry Observation

Schwan to Serve as Head of Sanofi China

On June 22, Sanofi announced that Shi Wang will assume the role of Head of China and General Medicines Lead for Greater China, effective August 1. As Country Lead of Sanofi China, Shi Wang will leverage various partnerships to enhance patient access to Sanofi's portfolio and continue to recruit and develop the next generation of talent in the Greater China region. (Sina Medicine News)

Guangyu Farma Two Vice Presidents Zhang Yi and Liang Peng Resign

On June 21, Guangyuzhen announced that the board of directors had recently received written resignation reports from the company's vice presidents Zhang Yi and Liang Peng. Both resigned from their positions as vice presidents due to personal reasons, and their resignation reports took effect from the date they were delivered to the company's board of directors. (Company Announcement)

Former Biogen Executive Chirfi Guindo Joins Merck, Appointed Chief Marketing Officer of Human Health

On June 21, Merck announced that Chirfi Guindo would serve as the Chief Marketing Officer of Human Health, reporting directly to CEO and President Robert M. Davis, effective July 1, 2022. He will be responsible for leading the formulation and implementation of the company’s long-term strategy, covering oncology, vaccines, and other human health products in the pipeline. (MedDRA Info)

AstraZeneca Establishes New CCiC Innovation Management Team

Recently, AstraZeneca announced the latest organizational restructuring and the establishment of a new CCiC Innovation Management Team, which will officially take effect on July 1. The specific personnel appointments are as follows: the original innovative market positions in each business unit will be formally transferred to the Digital and Commercial Innovation Department's CCIC Innovative Disease Management Team, led by Ms. Zhu Lili, the current Vice President of AstraZeneca China (Company Announcement).

Over $1.4 Billion! Novartis and Precision BioSciences Reach Global Exclusive Collaboration on In Vivo Gene Editing Therapy

On June 21, Precision BioSciences announced that it had entered into an exclusive global collaboration and licensing agreement with Novartis for in vivo gene editing research and development. Precision will receive a $75 million upfront payment and is eligible for up to approximately $1.4 billion in additional milestone payments. Precision is also eligible for certain research funding and, if Novartis successfully commercializes a therapy from the collaboration, Precision will receive mid-single-digit to low-double-digit royalties on product sales. (MedDRA Info)

Meiying Gene Officially Listed on the Hong Kong Stock Exchange

On June 22, Meiyin Gene (06667.HK) officially listed on the Hong Kong Stock Exchange. In early trading, Meiyin Gene opened at HK$19.48, up 8.22%, and surged to 16.39% at one point during the session. It closed at HK$18.00, with a trading volume of HK$3.8588 million. (Sina Medicine News)

Wuzhou Medical Plans to Issue 17 Million Shares for the First Time, IPO Priced at 26.23 Yuan per Share

On June 21, Wuzhou Medical released an announcement regarding the initial public offering of shares and listing on the ChiNext Board. The company plans to issue 17 million shares for the first time at an issue price of 26.23 yuan per share, with the expected issue date being June 24, 2022. (Sina Medicine News)

Raised 1.073 billion yuan! Taolue Bio's STAR Market IPO application accepted

On June 21, the Listing Committee meeting accepted the listing application of Taolue Biotech, a company within BioBAY Park. It is reported that Taolue Biotech plans to raise 1.073 billion yuan in this IPO for the research and development of innovative drug products. (Sina Medicine News)

Renfu Pharmaceutical: Subsidiary to Purchase Property Assets from Kemao Lide for 1.645 Billion Yuan

On June 22, Renfu Pharmaceutical (600079.SH), a company listed on the A-share market, announced that its subsidiaries Renfu Co., Ltd., Innovative Drug Research and Development Center, Tianrun Health, and Yichang Renfu purchased property assets from Wuhan Kemeilide Biomedical Co., Ltd. The total transaction amount was 1.645 billion yuan. (Company Announcement)

Connect Biopharma Receives Warning Letter, Faces Additional Compliance Deadline Risks

Recently, Connect Biopharma announced that it has received a warning letter from the Nasdaq Stock Exchange, stating that the company's ADS trading price has been below $1 per share for 30 consecutive trading days, which does not comply with Nasdaq Listing Rule 5550(a)(2). According to Nasdaq Listing Rule 5810(c)(3)(A), within 180 trading days from the date of notification until December 13, 2022, the company needs to regain compliance with the minimum bid price requirement, meaning its share price must exceed $1 for at least ten consecutive trading days. If compliance is not restored by December 13, 2022, the company may be eligible for an additional 180-day compliance period. (MedValley)

Carbon Completes $38 Million Series A Financing

Today, Carbon Biosciences announced the completion of a $38 million Series A financing round. This vector is capable of carrying larger transgenes, exhibits higher tissue specificity, and minimizes neutralizing immune responses. (WuXi AppTec)

Helixon Completes Nearly 500 Million Yuan Series A Financing

Recently, Huashen Zhiyao announced the completion of a nearly 500 million yuan Series A round of financing. This round of financing was led by FiveSource Capital, with Hillhouse Ventures continuing to increase its investment as the angel round investor. Other investors included Gaorong Capital, Neumann Capital, Xianghe Capital, and Qingzhi Capital. (Sina Medicine News)

Pharma News and Medical Updates

Qilu Pharmaceutical's Etanercept Biosimilar Not Approved

On June 21, 2022, Qilu Pharmaceutical's etanercept (recombinant human type II tumor necrosis factor receptor-antibody fusion protein) biosimilar received a notification of its marketing application, indicating that it was not approved. (Sina Medicine News)

Positive Results from Merck's V116-001 Phase 1/2 Clinical Trial; Phase 3 Clinical Trial Expected to Launch in July This Year

Merck Announces Positive Results from Phase 1/2 Clinical Trial V116-001 for Its Investigational 21-Valent Pneumococcal Conjugate Vaccine V116Merck today announced positive results from its V116-001 Phase 1/2 clinical trial. The V116-001 trial aims to evaluate the safety, tolerability, and immunogenicity of Merck's investigational 21-valent pneumococcal conjugate vaccine V116. These results were presented at the International Symposium on Pneumococci and Pneumococcal Diseases in June this year. Based on these results, Merck expects to initiate a Phase 3 clinical trial to evaluate V116 in July this year. (WuXi AppTec)

SinoCellTech: Positive Results from Phase I/II Clinical Study of Subsidiary's Recombinant COVID-19 Vaccine

June 22, Sinocelltech announced that the recombinant SARS-CoV-2 Alpha+Beta variant S trimer protein vaccine had undergone an interim analysis of the Phase I/II clinical trial for booster immunization with a single dose of SCTV01C in individuals previously vaccinated with inactivated vaccines in the UAE, yielding positive results. (Company Announcement)

AstraZeneca's Antisense Oligonucleotide Therapy Eplontersen Succeeds in Phase 3 Clinical Trial

On June 21, AstraZeneca and Ionis announced that their antisense oligonucleotide therapy eplontersen for the treatment of hereditary transthyretin amyloidosis polyneuropathy reached the co-primary endpoints in a planned interim analysis at 35 weeks of the Phase III NEURO-TTRansform trial: statistically and clinically significant changes in serum transthyretin (TTR) concentration and modified Neuropathy Impairment Score +7 (mNIS+7) relative to baseline. (Sina Medicine News)

‍Efavirenz, Lamivudine, and Tenofovir Tablets: Class 5.1 New Drug Application Submitted for Marketing in China

On June 22, the official website of the Center for Drug Evaluation of China's National Medical Products Administration (NMPA) announced that a new 5.1 class drug named Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate Tablets has been submitted for marketing approval in China. This medication is a triple-combination therapy developed by Mylan, primarily used for the treatment of AIDS. (Official website of the Center for Drug Evaluation of China's National Medical Products Administration)

3SBio's Nale舒单抗 Injection Submitted for Market Approval

On June 22, the CDE official website showed that 3SBio's Class 1 biological product, Nale舒单抗 Injection, submitted its marketing application and was accepted. 3SBio's Nale舒单抗 is the second China-produced CD20 antibody to apply for marketing, used for treating non-Hodgkin lymphoma. (CDE)

AbbVie Submits Regulatory Application for CGRP Receptor Inhibitor

AbbVie Submits sNDA for Oral CGRP Receptor Antagonist Qulipta to FDA for the Prevention of Migraine in Adults with Chronic Migraine. If approved, Qulipta would become the first oral CGRP receptor antagonist approved for the broad indication of preventing both episodic and chronic migraine. (WuXi AppTec)

BrightGene's Oseltamivir Phosphate for Oral Suspension Approved for Marketing

On June 22, BrightGene BioMedical announced that BrightGene BioMedical had received the "Drug Registration Certificate" for "Oseltamivir Phosphate for Oral Suspension" issued by the National Medical Products Administration. This drug is used for the treatment of influenza A and B in patients aged 2 weeks and above (Company Announcement).

Jingsheng Technology's Inhalation Solution of Ipratropium Bromide Approved for Marketing

Recently, Jing Sheng Technology's replica of the Category 4 inhaled Ipratropium Bromide Solution has been approved for marketing, which is considered as passing the consistency evaluation. In 2021, the sales of Ipratropium Bromide in China's public medical institutions terminals approached 1 billion yuan, increasing by 35.19% year-on-year. Ipratropium Bromide is a highly selective M receptor blocker suitable for maintenance treatment of bronchospasm caused by chronic obstructive pulmonary disease. (MENET)

BeiGene's Tislelizumab New Indication Marketing Authorization Application Accepted in China

On June 21, BeiGene announced that the NMPA and CDE have accepted the new indication marketing application for the anti-PD-1 antibody BeiGene's Baiduo® (tislelizumab) in combination with chemotherapy for first-line treatment of patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1. (Sina Medicine News)

CSPC Group/Jinmantu RNAKL Antibody Marketing Application Accepted

On June 22, the CDE website showed that the marketing application of JMT103, a RANKL antibody new drug developed by Jinmantu Bio, a subsidiary of CSPC Group, was accepted. Nale舒单抗 (Naleshuximab) is a new generation RANKL antibody, aiming to address the shortcomings of currently marketed RANKL antibodies, mainly immune suppression side effects and infection risks. (CDE)

Gan & Lee Pharmaceuticals' Sitagliptin Phosphate Tablets Receive Drug Registration Approval

Today, Gan & Lee Pharmaceuticals announced that its wholly-owned subsidiary, Gan & Lee Pharmaceuticals (Jiangsu) Co., Ltd., has recently received the product registration certificate for Sitagliptin Phosphate Tablets issued by the National Medical Products Administration. Sitagliptin Phosphate Tablets can be used to improve blood glucose control in patients with type 2 diabetes. (Company Announcement)

Merck's Cetuximab (Erbitux®) Approved for New Indication to Treat Locally Advanced Squamous Cell Carcinoma of the Head and Neck

On June 22, Merck announced that Erbitux® (Cetuximab Injection) has officially received NMPA approval for use in combination with radiotherapy to treat patients with locally advanced squamous cell carcinoma of the head and neck. With the approval of this indication, Erbitux® has now secured four indications in China. (NMPA)

Innovent Biologics' PD-1/IL-2 Antibody Fusion Protein Approved for Clinical Trials

Recently, the CDE official website announced that IBI363, a Class 1 new drug developed by Innovent Biologics, has received clinical trial implied permission. The proposed indication for development is advanced cancer. IBI363 carries immune cytokine stimulation and PD-1 antibody functions, retaining CD25 (IL2Rɑ) activity to maximize efficacy and high selectivity while reducing Rβγ binding to lower systemic toxicity. It is intended to improve IO treatment outcomes and address PD-1/PD-L1 resistance in patients and "cold tumors." (CDE)

JiaYin Bio's SMA Gene Therapy Registration Clinical Trial Approved

On June 21, Jiyin Bio announced that the clinical trial application for its self-developed AAV gene therapy EXG001-307 injection has been approved by the CDE, and it is proposed to be developed for the treatment of Type 1 Spinal Muscular Atrophy with bi-allelic mutations (deletions) in the Survival Motor Neuron 1 (SMN1) gene. (CDE)

Qilu Pharmaceutical's Carboplatin Injection Passes Generic Drug Consistency Evaluation, Becoming the First in China to Achieve This

On June 21, the NMPA official website showed that Qilu Pharmaceutical's Carboplatin Injection had passed the generic drug consistency evaluation, becoming the first in China to do so. Data shows that in 2021, the sales of Carboplatin Injection in Chinese public medical institutions reached nearly 700 million yuan, increasing by 29.65% year-on-year. (NMPA)

Taien Kang's Tadalafil Tablets Receive Drug Registration Certificate, Deemed to Pass Consistency Evaluation

On June 22, Tai'en Kang announced that its wholly-owned subsidiary, Huabo Kaisheng, had recently received the Drug Registration Certificate for Tadalafil Tablets (brand name: Atingwei®) issued by the National Medical Products Administration. The acquisition of this Drug Registration Certificate for Tadalafil Tablets is considered as passing the consistency evaluation (Company Announcement).

Moderna Plans to Deliver Omicron COVID-19 Vaccine in August, Awaiting Regulatory Approval

On June 22, according to Cailian Press, Moderna's CEO Stephane Bancel said on Wednesday that the company is ready to deliver the Omicron COVID-19 vaccine in August. Injection tests have been carried out, but regulatory approval is currently the only bottleneck for market supply. (Sina Medicine News)

Pfizer Seeks Japan Approval for Its COVID-19 Vaccine Booster for Children Aged 5-11

Latest news shows that Pfizer has applied to Japan's Ministry of Health, Labour and Welfare for approval to use its COVID-19 vaccine booster in children aged 5-11. (Sina Medicine News)