Northeast Pharmaceutical Appoints New CFO; Novo Nordisk Enters Collaboration for Next-Gen Obesity Therapy

[January 18, 2022 / Pharmaceutical News Overview]Mabwell's Sci-Tech Innovation Board IPO Plunged Over 29% on the First Day; A Subsidiary of Guangzheng Ophthalmology Was Prosecuted for Alleged Illegal Activities by Its General Manager, Junjie Li, and Corporate Bribery; Henlius HLX208 Monotherapy or Combination Therapy for Advanced Solid Tumors Approved for Clinical Trials...Daily fresh pharmaceutical news and medical updates, Speed Reading Society keeps you informed!

Part 1 Policy Brief

Six Registration Review Guidelines Released, Involving Intraocular Lenses, Microcatheters, etc.

On the 17th, NMPA released six medical device registration review guidelines, specifically: "Guidelines for the Registration Review of Disposable High-Pressure Contrast Injectors and Accessories," "Guidelines for the Registration Review of Metal Bone Plates for Internal Fixation Systems (2021 Revision)," "Guidelines for the Registration Review of Degradable Magnesium Metal Orthopedic Implants," "Guidelines for the Registration Review of Microcatheters," "Guidelines for the Registration Review of Disposable Endoscopic Injection Needles," and "Guidelines for the Registration Review of Intraocular Lenses." (NMPA)

Two Registration Review Guidelines for Drug-Device Combination Products Dominated by Medical Device Functions Released

On the 17th, the NMPA initiated a regulatory science research project focusing on the technical evaluation of drug-device combination products. It released the "Guiding Principles for Registration Review of Drug-Device Combination Products Dominated by Medical Device Function" and the "Guiding Principles for Registration Review of Qualitative and Quantitative Drug Analysis and In Vitro Release Studies in Drug-Device Combination Products Dominated by Medical Device Function." These guidelines aim to strengthen the supervision and guidance of registration work for drug-device combination products, further encourage the market entry of drug-device combination products with clinical value, and establish a management model suitable for China’s national conditions. (NMPA)

Doctor at a Health Center in Yuzhou City, Henan Province Confirmed with Diagnosis; Director Disciplined

On the 16th, the Disciplinary Inspection and Supervision Commission of Yuzhou City, Henan Province reported that Jia Xiaomin, the president of Chuhe Town Health Center in Yuzhou City, Henan Province, did not arrange for one of the medical staff to undergo home isolation after learning that the staff member was experiencing discomfort symptoms, and continued to allow them to work. Later, the medical staff was confirmed to be infected with COVID-19. Jia Xiaomin received an intra-party warning and administrative demerit. (Disciplinary Inspection and Supervision Commission of Yuzhou City, Henan Province)

Part 2: Industry Economy Observation

Abbisko and Eli Lilly and Company Reach Over $250 Million Collaboration

On January 18, Abbisko announced that it had entered into a global collaboration and exclusive license agreement with Eli Lilly and Company to further advance the discovery, development, and potential commercialization of novel small molecule drugs targeting undisclosed targets in major diseases with unmet medical needs, such as cardiometabolic disorders. According to reports, if Abbisko successfully advances the compound to the agreed endpoint, Eli Lilly will have the right to further develop and commercialize it. If Eli Lilly takes charge of clinical development and commercialization, Abbisko is entitled to receive up to $258 million based on the achievement of predetermined preclinical, clinical development, and commercial milestones, along with tiered royalties on sales generated under this agreement. (MedView)

Mabwell Debuts on STAR Market, Shares Plunge Over 29% on First Day

On the 18th, Mabwell Biotech was listed on the STAR Market of the Shanghai Stock Exchange. The company's stock code is 688062, with an issue price of 34.8 yuan per share. The funds raised will be used for the construction of a 1,000kg annual antibody industrialization project, antibody drug research and development projects, and replenishing working capital. As of the evening closing, Mabwell Biotech was trading at 24.5 yuan per share, with a decline of 29.6%, and a total market value of 9.79 billion yuan. (Sina Medicine News)

Optical Bright Eye Subsidiary Prosecuted for Alleged Illegal Activities and Unit Bribery Involving General Manager Li Junjie

On the 17th, Guangzheng Ophthalmology announced that it recently received an inquiry notice from the People's Procuratorate of Licang District, Qingdao City, and learned that its subsidiary, Qingdao New Vision, had been prosecuted by the People's Procuratorate of Licang District, Qingdao City, due to its general manager, Li Junjie, suspected of illegal crimes and corporate bribery. This case is currently under further trial at the People's Court of Licang District, Qingdao City. (Sina Medicine News)

Northeast Pharmaceutical Financial Director Zhou Kai Resigns, Xu Lei Takes Over

On the 17th, Northeast Pharmaceutical announced that Zhou Kai applied for resignation from the position of Chief Financial Officer due to work adjustment. After this adjustment, Zhou Kai will continue to serve as the General Manager of the company. Meanwhile, the board of directors agreed to appoint Xu Lei as the Chief Financial Officer of the company, with a term of office identical to that of the Ninth Board of Directors. (Corporate Announcement)

WuXi AppTec's 2021 Net Profit Up 68%-70% YoY

On the 18th, WuXi AppTec released its earnings forecast, expecting a net profit increase of 2.013 billion to 2.072 billion yuan for 2021, representing a year-on-year growth of 68%-70%. The integrated chemistry business unit continues to build its "integrated, end-to-end" CRDMO services, with strong order demand driving accelerated revenue growth for the full year. Laboratory analysis and testing services under the testing business, clinical CRO/SMO services, biology services, and small molecule drug discovery services under the chemistry business also maintained robust growth momentum. According to Xiao Cai’s note: Q3 net profit was 887 million yuan; based on this calculation, Q4 net profit is expected to be between 1.411 billion and 1.47 billion yuan, representing a quarter-on-quarter growth of 59%-65%. (Corporate Announcement)

Yabao Pharmaceutical 2021 Net Profit Up 54%-77% Year on Year

On the 18th, Yabao Pharmaceutical released a performance forecast, expecting to achieve a net profit attributable to shareholders of the listed company of 165 million yuan to 190 million yuan in 2021, representing a year-on-year increase of 53.68% to 76.96%. In 2021, the company focused on high-margin core products and increased promotional efforts. The revenues of high-margin products such as Dinggui'er Umbilical Patches, Xiaozhong Zhitong Patches, Yiya Jianpi Gel, and Children's Qingyan Jiere Oral Liquid all achieved significant growth. Due to the impact of the pandemic, the company’s 2020 net profit base was relatively small, resulting in a larger growth amplitude in this period compared to the same period last year. (Corporate Announcement)

Jiuzhou Pharmaceutical 2021 Net Profit Up 60%-80% Year on Year

On the 18th, Jiuzhou Pharmacy released its earnings forecast. The company expects that the net profit attributable to shareholders of listed companies for the fiscal year 2021 will be between 609 million yuan and 685 million yuan, increasing by 228 million yuan to 304 million yuan compared with the same period last year, representing a year-on-year increase of 60% to 80%. (Corporate Announcement)

Meihua Biologics' 2021 Net Profit Up 134%-144% Year on Year

On the 18th, Meihua Biotech released its earnings forecast, expecting a net profit of 2.3 billion to 2.4 billion yuan in 2021, representing a year-on-year increase of 134%-144%. The price increases for major products such as monosodium glutamate (MSG), threonine, lysine, xanthan gum, and other feed amino acid products far exceeded the rise in raw material costs; the disposal of its subsidiary, Shanxi Guangsheng Medical Packaging Co., Ltd., generated investment income of approximately 270 million yuan. Note from Xiaocai: Q3 net profit was 323 million yuan, and based on this calculation, Q4 net profit is expected to be between 973 million yuan and 1.073 billion yuan, representing a quarter-on-quarter increase of 201%-232%. (Corporate Announcement)

Part 3 Pharmaceutical News and Medical Information

Olumiant and Sotrovimab Receive WHO Recommendation for COVID-19 Treatment

Recently, WHO Recommended Two New Drugs for the Treatment of COVID-19: 1. Eli Lilly's JAK Inhibitor Olumiant (Baricitinib), recommended for the treatment of severe COVID-19 patients, suggested to be used in combination with corticosteroids; 2. GSK/Vir’s monoclonal antibody drug Sotrovimab, conditionally recommended for the treatment of mild or moderate COVID-19 patients at high risk of hospitalization. This includes older patients, those who are immunocompromised, have underlying conditions such as diabetes, hypertension, and obesity, as well as unvaccinated patients. (Sina Medicine News)

Novo Nordisk Reaches New Collaboration to Develop Next-Generation Weight Loss Therapy

On the 18th, EraCal Therapeutics announced a research and development collaboration with Novo Nordisk to jointly discover innovative drug targets related to the regulation of food intake and other metabolic phenotypes. According to the joint research plan, EraCal and Novo Nordisk will study the potential of novel molecules as anti-obesity therapies. This research will be conducted on zebrafish larvae, an emerging vertebrate drug discovery platform, aiming to provide insights into potential new targets within signaling pathways that control metabolic health. (WuXi AppTec)

Celon Pharma's Parecoxib Sodium for Injection Receives Approval for Supplemental Drug Application

On the 18th, Cylon Pharma announced that its wholly-owned subsidiary, Hunan Cylon Pharmaceutical, had recently received the "Drug Supplemental Application Approval Notice" for Parecoxib Sodium for Injection issued by NMPA. The main indication is for the short-term treatment of postoperative pain. (Corporate Announcement)

Luye Pharma's Painkiller Oxycodone/Naloxone Extended-Release Tablets Accepted for Review by CDE

On the 17th, Luye Pharma announced that the marketing application for Oxycodone/Naloxone Prolonged-Release Tablets (LY021702) has been accepted by the CDE. It is intended for treating moderate to severe chronic pain that cannot be effectively controlled by non-opioid medications, providing pain relief for up to 12 hours. Additionally, it can prevent abuse issues caused by opioid medications and reduce gastrointestinal adverse reactions such as constipation induced by this class of drugs. (PR Newswire)

Yangtze River Pharmaceutical's Vortioxetine Hydrobromide Tablets to Be Approved Soon

Recently, Yangtze River Pharmaceutical's hydrogen bromide vortioxetine tablet, reported for production as a Category 4 generic drug, has entered the administrative approval stage, striving to become the fourth domestically produced version in China. Vortioxetine is an antidepressant that simultaneously exhibits SERT inhibition, 5-HT1A receptor agonism, and 5-HT3 receptor antagonism. (Source: Menet)

Luye Pharma's Cefepime Hydrochloride for Injection Passes Generic Drug Consistency Evaluation

On the 18th, Luoxin Pharmaceutical announced that its subsidiary, Shandong Luoxin, had recently received the "Drug Supplemental Application Approval Notice" for Cefepime Hydrochloride for Injection approved and issued by the NMPA. This product has passed the generic drug consistency evaluation. The drug can be used to treat moderate to severe infections caused by susceptible bacteria in adults and children aged 2 months to 16 years, including lower respiratory tract infections, uncomplicated and complicated urinary tract infections, non-complicated skin and skin soft tissue infections, complicated intra-abdominal infections, obstetrics and gynecology infections, sepsis, and empirical treatment of patients with neutropenia accompanied by fever. It can also be used as a prophylactic medication for patients undergoing abdominal surgery and for bacterial meningitis in children. (Corporate Announcement)

China National Pharmaceutical Modern Cefoxitin Sodium for Injection (1.0g) Passes Generic Drug Consistency Evaluation

On the 18th, Sinopharm Modern announced that its holding subsidiary, Sinopharm Zhijun, received the "Drug Supplemental Application Approval Notice" for Cefoxitin Sodium for Injection (1.0g) approved and issued by the NMPA. The drug has been approved to pass the consistency evaluation. Cefoxitin Sodium is a cephamycin antibiotic with antibacterial effects and spectrum similar to second-generation cephalosporins. It is widely used in clinical settings for infectious diseases of the lower respiratory tract, urinary tract, intra-abdominal areas, gynecology, bones and joints, skin, and soft tissues. (Corporate Announcement)

Gannex's PD-L1 Antibody Receives FDA Approval for Hepatitis B Clinical Trial

On the 17th, Ascletis Pharma announced that the IND application for its subcutaneously injectable PD-L1 antibody ASC22 (Envonilimab) was approved in the United States for chronic hepatitis B. (Sina Medicine News)

Huao Tai Bio's Anti-PD-L1/TIGIT Bispecific Antibody Approved for Clinical Trials in the U.S.

On the 18th, Huahai Pharmaceutical announced that the U.S. FDA had approved the clinical trial application for HB0036 injection from its subsidiary, Huaotai Bio. Public information shows that HB0036, independently developed by Huaotai Bio, is a bispecific antibody targeting PD-L1 and TIGIT. (Corporate Announcement)

FDA Approves Clinical Application for iPSC-Derived Innovative CAR-NK Therapy

Recently, Fate Therapeutics announced that the US FDA has approved the IND application for FT536. This is a multi-engineered, induced iPSC-derived "off-the-shelf" chimeric antigen receptor natural killer cell therapy. (WuXi AppTec)

Nektar Therapeutics IL-2 Immunostimulatory Therapy Approved for Clinical Trials in China

On the 18th, the CDE announced that bempegaldesleukin, submitted by Nektar Therapeutics, has received tacit approval for clinical trials, intended for development in squamous cell carcinoma of the head and neck. (CDE)

Henlius HLX208 Monotherapy or Combination Therapy for Advanced Solid Tumors Approved for Clinical Trials

On the 18th, Fosun Pharma announced that its holding subsidiary, Henlius, had received approval from the NMPA to conduct clinical trials for HLX208, a small molecule inhibitor targeting the V600E mutation of the human BRAF protein, as a monotherapy or in combination therapy for advanced solid tumors. (Corporate Announcement)