Executive Reshuffles at Multiple Pharmaceutical Companies Including Fosun Pharma and Sihuan Pharmaceutical

[March 2, 2021 / Pharmaceutical News Brief]Multiple pharmaceutical executives resign: Involving Fosun Pharma, Sihuan Biology, and others; Pfizer’s BRAF inhibitor approved for clinical trials in China...Daily Fresh Pharmaceutical and Medical News, Speed Reading Club Pays Attention with You!

Part 1 Policy Brief

National Health Commission: Infection Prevention and Control to Become a Compulsory Course for Undergraduate Medical Students

Recently, the National Health Commission released its response to the “Proposal on Strengthening Support for the Development of Infection Prevention and Control Departments in Healthcare Institutions,” submitted during the Third Session of the National People’s Congress. The response stated that infection prevention and control will become a compulsory course in undergraduate medical education. Depending on the target audience, relevant knowledge on infection prevention and control will be incorporated into the mandatory curriculum for clinical internships, standardized residency training, and continuing medical education, with corresponding education, training, and assessments conducted. (National Health Commission)

Beijing to Launch Comprehensive COVID-19 Vaccination Campaign for the Elderly at an Appropriate Time

It is reported that, in accordance with the national overall arrangement, Beijing has currently administered COVID-19 vaccines to some individuals aged 60 and above who have vaccination needs and are in relatively good health. The next step will be for Beijing to comprehensively roll out vaccinations for the elderly population at an appropriate time, as guided by national directives. Vaccination arrangements for individuals under 18 years of age across the city will be implemented in line with unified national requirements, based on vaccine research and development progress and subsequent clinical trial results. (Cailianshe)

“Hometown of Medicinal Herbs” Bozhou: Prices of Traditional Chinese Medicinal Materials Rise Broadly, with Accelerated Growth Since the Fourth Quarter of Last Year

On March 2, the Bozhou Municipal Development and Reform Commission launched an investigation into the widespread price increases in the local traditional Chinese medicine (TCM) materials market, in accordance with requirements from the Price Department of the National Development and Reform Commission and the Cost Supervision and Review Bureau of the Anhui Provincial Development and Reform Commission. Prices for TCM materials in Bozhou have risen broadly since 2020, with the rate of increase accelerating after the fourth quarter. As of the end of December 2020, the TCM Comprehensive 200 Index stood at 2,457.21 points, representing an 8.52% increase from 2,260.71 points on January 20, 2020. In January 2021, prices rose for 128 varieties of TCM materials, with significant increases observed in Vaccariae Semen, Hyoscyami Semen, Polygoni Orientalis Fructus, Stamen Nelumbinis, Lonicerae Flos (Shan Yin Hua), and Stephaniae Tetrandrae Radix (Bai Yao Zi), among others. (Cailianshe)

Shanghai: Excessive Pricing of Fudan-Zhangjiang and Jinyuan Pharmaceutical’s Doxorubicin Hydrochloride Liposome Injection

On March 2, the Shanghai Municipal Pharmaceutical Centralized Bidding and Procurement Management Office issued an announcement stating that, in accordance with the “Notice on Further Strengthening the Procurement and Use Management of Self-Pay Drugs at Designated Medical Institutions Covered by Basic Medical Insurance in This Municipality” and the “Notice on Further Improving the Online Procurement of Self-Pay Drugs in This Municipality,” verification revealed that the five-province/city price information reported for certain self-pay drugs was inconsistent with the data on the National Administration Platform, and that the lowest negotiated prices from both sources were higher than the lowest prices recorded among the five provinces/cities. (Shanghai Municipal Pharmaceutical Centralized Bidding and Procurement Management Office)

Part 2: Industry and Economic Observation

InnoCare Pharma Appoints Zhang Xiangyang as Chief Medical Officer

InnoCare Pharma Appoints Zhang Xiangyang as Chief Medical OfficerIt is reported that InnoCare Pharma announced yesterday the appointment of Zhang Xiangyang as the company’s Chief Medical Officer. He will report to Dr. Cui Jisong, Co-founder, Chairman, and CEO of InnoCare Pharma, and will be fully responsible for the strategy and execution of the company’s global clinical development. (PR Newswire)

Fosun Pharma Vice President Chen Zhanyu Steps Down; Li Dongjiu Succeeds Him

Yesterday, Fosun Pharma issued two announcements, stating that Mr. Chen Zhanyu, former Vice President of the company, had resigned from his position as Vice President and would no longer hold this role effective March 1, 2021. On the same day, the company announced that the 34th (extraordinary) meeting of the 8th Board of Directors reviewed and approved the proposal regarding the appointment of senior management personnel, agreeing to appoint Mr. Li Dongjiu as Senior Vice President of the company, with his term starting from March 1, 2021, until the expiration of the current board's term. (Fosun Pharma Announcement)

Sihuan Shengwu Director Huang Xi Resigns

On March 1, Sihuan Bio issued an announcement stating that it had recently received a written resignation report from Mr. Huang Xi, a director of the company. Mr. Huang Xi has applied to resign from his position as a director of the ninth board of directors of the company due to personal reasons. His resignation shall take effect from the date of delivery to the board of directors. After his resignation, Mr. Huang Xi will no longer hold any positions within the company. (Sihuan Bio Announcement)

Director of Organon’s Women’s Health Division, Newly Spun Off from MSD, May Have Departed

Recent reports reveal that the Director of Organon’s Women’s Health Division has resigned, with their last working day being February 28. The new director is scheduled to assume the position in mid-March. It is reported that Organon was formerly the Primary Care and Women’s Health Division of Merck Sharp & Dohme (MSD) and began its spin-off from MSD last year. (Sina Pharmaceutical News)

Salubris Deputy General Manager Zhao Wanshun Resigns

On March 2, Salubris Pharmaceutical issued an announcement stating that it had recently received a written resignation report from Mr. Zhao Wanshun, the Company’s Deputy General Manager. Mr. Zhao Wanshun has applied to resign from his position as Deputy General Manager due to personal reasons. Upon the effectiveness of his resignation, he will no longer hold any position within the Company. (Salubris Pharmaceutical Announcement)

Sinopharm Accord Director Li Dongjiu Resigns

On March 2, Sinopharm Group Consistency announced that its Board of Directors recently received a written resignation report from Director Mr. Li Dongjiu. Mr. Li Dongjiu has applied to resign from his positions as a director of the Eighth Board of Directors, and as a member of the Board’s Strategic Committee and Legal Compliance Committee due to adjustments in work arrangements. (Sinopharm Group Consistency Announcement)

Daiichi Sankyo Initiates Workforce Reductions

Today, according to a report by a WeChat public account, Daiichi Sankyo is currently undergoing layoffs, affecting its anti-infective and respiratory analgesic product lines. The layoffs are primarily targeting sales representatives in regions outside Beijing, Shanghai, and Guangzhou, focusing on those with lower sales performance and shorter tenure. (Sina Pharmaceutical News)

Kanghong Pharmaceutical Vice President, CFO and Board Secretary Zhong Jianjun Receives Regulatory Letter for "Illegal Stock Purchase"

Kanghong Pharmaceutical’s Vice President, CFO, and Board Secretary Zhong Jianjun Received a Regulatory Letter from the SME Company Management Department of the Shenzhen Stock Exchange. The regulatory letter pointed out that Zhong Jianjun, as the company's Vice President, CFO, and Board Secretary, purchased 77,300 shares of the company's stock within ten days before the disclosure of the company's 2020 preliminary earnings report, amounting to RMB 2.8773 million. His aforementioned actions violated relevant provisions of the Shenzhen Stock Exchange's "Rules Governing the Listing of Stocks (Revised in 2020)." (China.org.cn)

AstraZeneca Sells Moderna Shares, Cashing Out $1.2 Billion

According to a Sunday report by Reuters in France, AstraZeneca sold its 7.7% stake in Moderna for over $1 billion. Previously, The Times of the UK had also reported in real time that the total amount of AstraZeneca's stock sale was approximately $1.2 billion. (Sina Pharmaceutical News)

Artiva Completes $120 Million Series B Financing

Recently, Artiva announced the completion of a $120 million Series B financing round. The round was led by new investor Venrock Healthcare Capital Partners, with participation from new investors Acuta Capital Partners, Cormorant Asset Management, EcoR1 Capital, Franklin Templeton, Janus Henderson Investors, Logos Capital, RTW Investments, LP, Surveyor Capital, Wellington Management Company, and an undisclosed globally leading investment firm, as well as existing investors 5AM Ventures, RA Capital Management, venBio Partners, and strategic partners GC LabCell and GC. Artiva plans to use the proceeds to advance its ongoing research and development activities and future development plans for its NK cell therapies. (Chuangjianhui)

Part 3 Pharmaceutical News and Medical Updates

Betta Pharmaceuticals: Results of Dynamic ctDNA Analysis from the Phase 2 Study of EnsartinibHairCloth

On March 1, Betta Pharmaceuticals issued a press release stating that the Journal of Thoracic Oncology, a renowned international oncology journal, published online the results of dynamic circulating tumor DNA (ctDNA) analysis from the Phase II clinical study of ensartinib capsules. The study investigated the mechanisms underlying resistance to ensartinib capsules in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), revealing partial mechanisms of tumor evolution toward resistance during ensartinib treatment. These findings can effectively guide future research directions and clinical practice. (Medical Perspective)

Poly Pharmaceutical: Successful Challenge to U.S. Patent for Bivalirudin for Injection

On March 2, Poly Pharmaceutical announced that the company received tentative approval from the U.S. Food and Drug Administration (FDA) for Bivalirudin for Injection in December 2020, and initiated a patent challenge against the original drug’s marketing authorization holder and patent holder in January 2021. As of now, the company has not received any litigation information from the original marketing authorization holder or patent holders, indicating that the patent challenge for this product was successful. (Poly Pharmaceutical Announcement)

ASKC’s Subsidiary’s Marketing Authorization Application for Palbociclib Capsules Accepted

On March 1, Askal announced that its wholly-owned subsidiary, Jiangsu Askal Pharmaceutical Co., Ltd., had recently received the "Notice of Acceptance" from the National Medical Products Administration (NMPA) for the domestic production and marketing authorization application of Palbociclib Capsules. This drug is indicated for the treatment of locally advanced or metastatic breast cancer that is hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-negative, and should be used in combination with an aromatase inhibitor as initial endocrine therapy for postmenopausal female patients. (Askal Announcement)

Chenxin Pharmaceutical | Hainan Huayi Taikang Pharmaceutical's Marketing Application for Valsartan and Hydrochlorothiazide Tablets Accepted

On March 2, the CDE website showed that the marketing application for Valsartan and Hydrochlorothiazide Tablets, submitted as a generic drug under Category 4 by Shineway Pharmaceutical/Hainan Huayitaikang Pharmaceutical, has been accepted. Data indicates that Valsartan and Hydrochlorothiazide Tablets are indicated for the treatment of mild to moderate essential hypertension in patients whose blood pressure is not adequately controlled with monotherapy. The product was originally developed by Novartis Pharmaceuticals of Switzerland, approved by the FDA for marketing in the United States in 1998, and launched in China in 2005. (Menet)

Tianjin Pharmaceutical Group’s Dexamethasone Sodium Phosphate API Passes Technical Review by the NMPA Center for Drug Evaluation

On March 2, Tianjin Pharmaceutical announced that the company’s Betamethasone Sodium Phosphate active pharmaceutical ingredient (API) has been approved by the NMPA.Technical review by the Center for Drug Evaluation (CDE); the registration status indicator for Betamethasone Sodium Phosphate has been updated to “A” on the CDE’s public platform for registration information of active pharmaceutical ingredients (APIs), pharmaceutical excipients, and packaging materials. Betamethasone Sodium Phosphate is an adrenocortical hormone drug primarily indicated for allergic and autoimmune inflammatory diseases; active rheumatism, rheumatoid arthritis, systemic lupus erythematosus, severe bronchial asthma, severe dermatitis, acute leukemia, and other conditions; as well as for the combined treatment of certain infections. (Announcement by Tianjin Pharmaceutical Co., Ltd.)

Weikang Pharmaceutical Receives Approval Notice for Supplemental Applications of JinQianCao Capsules and GanSu Capsules

On March 2, Weikang Pharmaceutical issued an announcement stating that it had recently received the Notice of Approval for Supplementary Drug Applications for Jinqiancao Capsules and Gansu Capsules, approved and issued by the National Medical Products Administration (NMPA). It is understood that Jinqiancao Capsules are primarily used to clear damp-heat, promote diuresis, reduce swelling, and treat heat-induced stranguria, sandy stranguria, painful and difficult urination, jaundice with dark urine, abscesses and furuncles, venomous snake bites, hepatobiliary calculi, and urinary tract calculi. The indications and functions of Gansu Capsules include lowering enzyme levels, protecting the liver, alleviating jaundice, and strengthening the spleen. They are indicated for chronic active hepatitis and hepatitis B, and may also be used for acute viral hepatitis. (Weikang Pharmaceutical Announcement)

Pfizer's BRAF Inhibitor Approved for Clinical Trials in China

According to information from the website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA), Pfizer’s BRAF inhibitor encorafenib hard capsules have received implicit approval for a clinical trial, with plans to develop the drug for the treatment of colorectal cancer. Publicly available data indicate that this drug has already been approved by the U.S. FDA for the treatment of adult patients with metastatic colorectal cancer harboring the BRAF V600E mutation. (Medical Observer)

Hansoh Pharmaceutical’s Decitabine for Injection Approved via Supplemental Application and Passes Consistency Evaluation

Recently, the official website of the National Medical Products Administration (NMPA) announced that Jiangsu Hansoh Pharmaceutical’s Decitabine for Injection has been approved through a supplemental application. Prior to this, no company had received approval for Decitabine for Injection. Decitabine is indicated for the treatment of myelodysplastic syndromes. (Menet Network)

Jincheng Pharmaceutical’s Ceftriaxone Sodium for Injection Passes the Consistency Evaluation of Quality and Efficacy for Generic Drugs

On March 2, Jincheng Pharmaceutical announced that its subsidiary’s Ceftriaxone Sodium for Injection had passed the consistency evaluation of quality and efficacy for generic drugs. Clinically, ceftriaxone sodium is generally used to treat meningitis, abdominal infections, bone and joint infections, skin and soft tissue infections, genital infections (including gonorrhea), renal and urinary tract infections, and preoperative infections caused by susceptible bacteria. (Jincheng Pharmaceutical Announcement)

Merck KGaA Secures Exclusive Global Development Rights for Debiopharm’s Targeted Therapy for Head and Neck Cancer

On March 1, Debiopharm announced that it had signed an exclusive licensing agreement with MSD for the development and commercialization of xevinapant. Xevinapant is a potential first-in-class, potent, oral antagonist of inhibitor of apoptosis proteins (IAPs). It is currently being evaluated in the pivotal Phase 3 TrilynX study, in combination with platinum-based chemotherapy and standard fractionated intensity-modulated radiation therapy (IMRT), for patients with previously untreated, high-risk, locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). Under the terms of the licensing agreement, MSD has obtained exclusive global rights to develop and commercialize xevinapant. (Immediate Pharma News)

Merck Voluntarily Withdraws Keytruda’s Indication for the Treatment of Patients with Metastatic Small Cell Lung Cancer

On March 1, Merck & Co., Inc. (known as MSD outside the United States and Canada) announced that it would voluntarily withdraw the U.S. indication for Keytruda in the treatment of patients with metastatic small cell lung cancer (SCLC) whose disease has progressed during or following platinum-based chemotherapy and at least one other prior line of therapy. Reportedly, the withdrawal of this indication was completed in consultation with the U.S. Food and Drug Administration (FDA), and Merck is working to finalize this change within the coming weeks. (Sina Medical News)