Resignations of Senior Executives at Hayao Pharmaceutical and 3SBio; Both Companies Advance IPO Filings

[January 13, 2022 / Pharmaceutical News Overview]CStone Pharmaceuticals' Anti-PD-L1 Monoclonal Antibody Reaches Primary Endpoint in Another Registrational Clinical Trial; Wang Penghao, Vice President of Hayao Group, Resigns for Personal Reasons, Lin Guoren Takes Over; Two Hospitals in Xi'an Undergo Business Suspension for Delayed Treatment, Company's Stock Price Plummets...Daily fresh pharmaceutical news and medical updates, Speed Reading Society keeps you informed!

Part 1 Policy Brief

NMPA Releases Revised Cimetidine Injection Formulation Instructions

On the 12th, based on the assessment results of adverse drug reactions, and in order to further ensure public medication safety, the NMPA issued the "Announcement on Revising the Instructions for Cimetidine Injection Preparations," deciding to uniformly revise the instructions for Cimetidine Injection Preparations (including Cimetidine Injection, Injectable Cimetidine, and Cimetidine Sodium Chloride Injection). (NMPA)

The 14th Five-Year Plan for Eye Health in China Issued, Focusing on Eye Disease Prevention and Low Vision Rehabilitation

On the 11th, the National Health Commission issued the "14th Five-Year Plan" for National Eye Health (2021-2025), focusing on the prevention and treatment of eye diseases such as trachoma, cataracts, myopia in children and adolescents, and low vision rehabilitation, aiming to improve the eye health level of the people. (National Health Commission)

NHCC Releases Regulations on Pharmaceutical Representative Visits

Recently, the Jiangxi Health Commission released the "Notice on Issuing the Management Measures for Pharmaceutical Representatives Visiting Staff in Medical Institutions (2021)", which is the first provincial-level management regulation targeting visits by pharmaceutical representatives. The Measures aim to further strengthen the construction of professional conduct within medical institutions across the province, standardize the professional behavior of pharmaceutical representatives in medical institutions, reinforce industry discipline, address misconduct in the pharmaceutical procurement sector, and enhance the self-discipline and integrity of medical institution staff. (Jiangxi Health Commission)

Part 2: Industry Economic Observation

Sanofi Strikes Over $1 Billion Deal for Blood-Brain Barrier Bispecific Antibody

Recently, South Korean ABL Bio announced a global exclusive collaboration and licensing agreement with Sanofi to co-develop and commercialize ABL301. Under the terms of the agreement, ABL Bio will receive an upfront payment of $75 million and is eligible for up to $985 million in future development, regulatory, and commercial milestone payments, along with royalties on net product sales. Sanofi will obtain global exclusive rights to develop and commercialize ABL301. (WuXi AppTec)

Philips Respironics Recall Leads to Nearly 20% Year-on-Year Decline in Q4 Earnings

Latest news on the 12th, Philips warned before the finalization of the Q4 earnings report that its revenue during this period would be much lower than previously forecasted. Additionally, Philips outlined measures to further expand the recall of ventilators, which has led to some financial losses for the company. According to the latest estimates from the company, Philips’ global total sales in the last quarter of 2021 are expected to reach 4.9 billion euros (approximately 5.6 billion US dollars), a decrease of about 350 million euros compared to Philips' previous revenue estimate for this period, and a year-on-year decrease of up to 18% compared to 6 billion euros in revenue in the last quarter of 2020. (Sina Medicine News)

BioNTech Expects 2022 COVID-19 Vaccine Revenue to Reach 17 Billion Euros

BioNTech Latest: COVID-19 Vaccine Revenue May Fall Below Last Year, Sales Forecast at €13 Billion to €17 BillionBioNTech recently indicated that the revenue from its COVID-19 vaccine co-marketed with Pfizer may fall below last year's figures, with projected sales ranging between €13 billion and €17 billion. The company released its 2022 forecast in an investor report on Tuesday and will announce its Q4 financial results on March 30. Following this news, BioNTech shares rose by 0.7% in Frankfurt. (PharmaCircle)

CSRC Approves Rongchang Bio's STAR Market IPO

On the 12th, Rongchang Bio announced that the registration application for the issuance of Rongchang Bio's A-shares has been approved by the CSRC. This issuance is expected to publicly offer no more than 54,426,301 shares of A-shares, accounting for no less than 10% of the total shares after the issuance, with funds raised amounting to approximately 4 billion yuan. The net proceeds after deducting issuance expenses are planned to be invested in the industrialization of new biopharmaceuticals, the research and development of new anti-tumor antibody drugs, as well as the research and development of antibody drugs for autoimmune and ophthalmic diseases. (Corporate Announcement)

Hualan Vaccine's ChiNext IPO Approved by CSRC

On the 13th, Hualan Bio announced that its controlling subsidiary, Hualan Vaccine, had received registration from the China Securities Regulatory Commission for its initial public offering of shares on the ChiNext Board. The prospectus shows that Hualan Vaccine plans to issue no more than 40.01 million shares, raising 2.495 billion yuan for five projects including the development and industrialization of a new pneumonia vaccine. (Corporate Announcement)

Vice President of Hayao Co., Ltd., Wang Penghao, Resigns for Personal Reasons; Lin Guoren Takes Over

On the 13th, Hayao Co., Ltd. announced that Wang Penghao, the company's vice president, has resigned for personal reasons and will no longer hold any other positions in the company after resignation. At the same time, upon the nomination of General Manager Xu Haiying and after review by the Board of Directors' Nomination Committee, the Board decided to appoint Lin Guoren as the vice president. The term of office will commence from the effective date of the Board resolution until the end of the ninth Board's term. (Corporate Announcement)

Departure of ZHU ZHENPING, Director, Senior Management, and Core Technical Staff of 3SBio Inc.

On the 12th, 3SBio announced that ZHU ZHENPING, a director, senior executive, and core technical staff member, has applied to resign from his position due to work adjustments. After leaving, he will no longer hold any position in the company. (Corporate Announcement)

Two Hospitals in Xi'an Undergo Closure for Rectification Due to Delayed Treatment; Company's Stock Price Plummets

On the 13th, the Xi'an Municipal Health Commission announced that due to the delay in the rescue and treatment of critically ill patients, the Xi’an Gaoxin Hospital and Xi’an International Medical Center Hospital, under the International Medical Group, were given disciplinary actions including suspension for rectification, removal of relevant responsible persons, and summoning the main hospital executives for discussions. Following this news, the company's stock price plummeted to the daily limit down. As of today's closing, International Medical Group was trading at 8.37 yuan per share, with a total market value of 19.05 billion yuan. (Xi'an Municipal Health Commission)

Conba Pharmaceutical 2021 Net Profit Up 325%-375% Year on Year

On the 13th, Conba released its earnings forecast, expecting a net profit increase of 1.475 billion to 1.7 billion yuan for 2021, representing a year-on-year increase of 325%-375%. The company's transfer of 42% equity in ZSM in December 2021 is expected to increase the company's net profit for 2021 by approximately 23 billion yuan. (Corporate Announcement)

Zixin Pharmaceutical Industry Co., Ltd. 2021 Annual Loss Forecast: RMB 430 Million - RMB 485 Million

On the 13th, Zixin Pharmaceutical Industry released its earnings forecast. The company expects to achieve a net profit attributable to shareholders of listed companies of RMB -430 million to -485 million for January-December 2021, compared with a loss of RMB 706 million in the same period last year, representing a year-on-year reduction in losses of 31.28%-39.07%. (Corporate Announcement)

Rui Zheng Gene and N1 Life Establish Joint Venture

On the 13th, Rui Zheng Gene and N1 Life announced a partnership to establish a joint venture named Lian An Ju Rui in China, jointly developing a new generation of drug delivery systems to advance the clinical translation of candidate drugs. (PR Newswire)

Part 3 Pharmaceutical News and Medical Information

CStone Pharmaceuticals' Anti-PD-L1 Monoclonal Antibody Reaches Primary Endpoint in Another Registrational Clinical Trial

On the 13th, CStone Pharmaceuticals announced that the registrational clinical study of Sugemalimab Injection for the treatment of relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) has met its primary endpoint. The results showed that, as assessed by the Independent Radiologic Review Committee (IRRC), Sugemalimab significantly improved the objective response rate (ORR) compared to historical controls; the ORR evaluated by investigators was consistent with the IRRC assessment results; moreover, Sugemalimab demonstrated good safety in R/R ENKTL patients without any new safety signals identified. (WuXi AppTec)

CIBOM Biotech's Dual-Target CAR-T Therapy Receives FDA Regenerative Medicine Advanced Therapy Designation

On the 12th, Cellular Biomedicine Group announced that the U.S. FDA granted C-CAR039 Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track status for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma. (WuXi AppTec)

CSPC Group's Lenvatinib Mesylate Capsules Approved for Marketing

NMPA's official website has recently announced that BeiGene's anti-PD-1 antibody, tislelizumab, has received approval for a new indication. According to public information, this is the sixth indication approved for tislelizumab in China, specifically for: treating second- or third-line locally advanced or metastatic non-small cell lung cancer patients who have experienced disease progression after receiving platinum-based chemotherapy. (NMPA)

Fuan Pharmaceutical's Wholly-Owned Subsidiary's Doxofylline Injection Approved for Marketing in China

On the 13th, Fuan Pharmaceutical announced that its wholly-owned subsidiary, Fuan Pharmaceutical Group Zhichu Pharmaceutical, had recently received the drug registration certificate issued by the NMPA. The doxofylline injection is mainly applicable to bronchial asthma, chronic wheezing bronchitis, and other bronchospasm-induced breathing difficulties. (Corporate Announcement)

Wu Biology's Humulus Pollen Prick Solution Marketing Authorization Application Accepted

On the 13th, Wuhan Allergenic Biotechnology Co., Ltd. announced that the company had recently received the "Acceptance Notice" issued by the NMPA. The marketing authorization application for "Humulus Pollen Prick Solution" has been officially accepted for use in prick tests to assist in diagnosing Type I hypersensitivity reactions caused by Humulus pollen allergens. (Corporate Announcement)

BeiGene's BTK-Targeted Protein Degrader BGB-16673 Approved for Clinical Trials in China

On the 11th, the NMPA official website showed that the Mitoxantrone Hydrochloride Liposome Injection and Lenvatinib Mesylate Capsules developed by CSPC Pharmaceutical Group were approved for marketing. Lenvatinib Mesylate Capsules are multi-target receptor tyrosine kinase inhibitors with target sites including VEGFR1-3, FGFR1-4, PDGFRα, KIT, RET, etc. They were approved for marketing in China in September 2018 for the treatment of patients with hepatocellular carcinoma. (NMPA)

Chipscreen Biosciences' Tucidinostat Phase II Clinical Trial Application for Non-Small Cell Lung Cancer Approved

On the 13th, Chipscreen Biosciences announced that the Phase II clinical trial of Chidamide combined with Tislelizumab for first-line treatment of locally advanced or metastatic non-small cell lung cancer with positive PD-L1 expression has been approved. (Corporate announcement)

Kelun Pharma's Small Molecule STING Agonist KL340399 Injection Approved for Clinical Trials

On the 11th, Kelun Pharmaceuticals announced that the Class 1 new drug KL340399 injection has been approved for clinical trials. This drug is a new generation small molecule STING agonist, and there are currently no drugs targeting the same point approved for marketing. The Class 1 new drug KL340399 injection is a new generation small molecule STING agonist developed by Kelun Pharmaceuticals with independent intellectual property rights and is not a cyclic dinucleotide class. (Corporate announcement)