Pfizer Recalls 12 Batches of Smoking Cessation Drug Chantix Due to Excess Carcinogenic Impurities; Results of 390-Drug Centralized Procurement Set to Take Effect

【July 21, 2021 / Pharmaceutical News Roundup】Bo'ai Biopharmaceutical fined RMB 3.01 million for manufacturing counterfeit drugs; Ding Fujun, Board Secretary of Yisheng Pharmaceutical, resigns; Takeda's recombinant von Willebrand factor Phase 3 clinical trial meets primary endpoint; Bristol Myers Squibb's LAG-3/PD-1 combination therapy approved for clinical trials in China...Daily Pharma & Medical News Briefs: Quick Reads on What Matters to You!

Part 1: Policy Brief

# Centralized Volume-Based Procurement Results for 390 Drugs to Take Effect

On the 20th, the Jilin Provincial Public Resource Trading Center released the 《Notice on Implementing the Selected Results of the First and Second Batches of Medicines in the 2021 Centralized Drug Procurement for Medical Institutions in Jilin Province》. The notice indicates that the selected results for the two announced batches cover 390 drug products and 301 pharmaceutical companies, and will take effect on August 1. (Jilin Provincial Public Resource Trading Center)

Bo'ai Biotech Fined 3.01 Million Yuan for Manufacturing Counterfeit Drugs; Legal Representative Receives Lifetime Industry Ban

On the 20th, an administrative penalty decision disclosed by the Tianjin Medical Products Administration revealed that Bo'ai Pharmaceutical was subject to fines and confiscations totaling 3,005,625.5 RMB for producing the counterfeit drug "Xiao Baidu Gao." Meanwhile, Xia Xuecheng, legal representative of Bo'ai Biotechnology, was held primarily responsible. He had 10,000 RMB of income derived from the unit during the period of the violation confiscated, and was further fined 30,000 RMB (three times the illicit income), totaling 40,000 RMB; he is also banned for life from engaging in drug production and business activities. (Tianjin Medical Products Administration)

Part 2: Industry & Economic Insights

Medicilon Appoints Dai Xuedong as Executive Vice President of the International R&D Services Department

Recently, Medicilon announced the appointment of Dr. Dai Xuedong as Executive Vice President of its International R&D Services Department. (Sina Pharmaceutical News)

Harbour BioMed Announces New CFO

Harbour BioMed announced today the official appointment of Dr. Yingying Chen as Chief Financial Officer, reporting directly to Dr. Jinsong Wang, Founder, Chairman and Chief Executive Officer of Harbour BioMed. (WuXi AppTec)

Yisheng Pharmaceutical Board Secretary Ding Fujun Resigns; Li Tiejun Takes Over

On the 21st, Yisheng Pharmaceutical announced that Mr. Ding Fujun has applied to the Board of Directors to resign from his positions as Deputy General Manager and Secretary to the Board of Directors due to personal reasons. Additionally, the company unanimously agreed to appoint Mr. Li Tiejun as the Secretary to the Board of Directors. (Corporate Announcement)

BioNTech Acquires Gilead Subsidiary's R&D Platform

Recently, BioNTech announced that it has entered into an agreement with Kite, a subsidiary of Gilead, to acquire the latter’s solid tumor neoantigen T-cell receptor (TCR) R&D platform, along with its manufacturing facility located in Gaithersburg, Maryland. The financial terms of the transaction were not disclosed. (Bioon)

China Resources Pharmaceutical to Acquire 10% Stake in Yongtai Biotech for HK$800 Million

On the 20th, China Resources Pharmaceutical Group announced that its wholly-owned subsidiary, Beijing Pharmaceutical Investment Management, entered into a share purchase agreement with YueCheng International Capital (HK) Limited, Hualida Development Co. Limited, Ren Xiaojuan, and BeiNi Ltd. Pursuant to the agreement, the buyer conditionally agreed to purchase, and the seller conditionally agreed to sell, a total of 51.4584 million ordinary shares of Yongtai Biopharma, representing 10.0% of Yongtai’s total issued share capital as of the date of this announcement. The total consideration is approximately HK$799.7 million, equivalent to HK$15.54 per share. (Corporate Announcement)

Amylyx Pharmaceuticals Completes $135 Million Series C Funding Round

On the 20th, Amylyx Pharmaceuticals announced the completion of a $135 million Series C financing round. The proceeds will be used to support the clinical development and commercialization plans for its lead candidate, AMX0035, for the treatment of amyotrophic lateral sclerosis (ALS), as well as the further development of potential therapies for other neurodegenerative diseases. (WuXi AppTec)

Rivus Pharmaceuticals Completes $35 Million Series A Financing

On the 20th, Rivus Pharmaceuticals announced the completion of a $35 million Series A financing round. The proceeds will be used to advance the development of a potential "first-in-class" oral small-molecule drug—a "controlled metabolic accelerator"—designed to harness the body's natural processes to improve cellular metabolism, addressing the underlying causes of cardiometabolic diseases. (WuXi AppTec)

Yuanguji Secures Nearly 100 Million RMB in Series A Funding

Recently, Yuanguji announced the completion of a Series A financing round of nearly RMB 100 million. The proceeds from this round will primarily be allocated to the construction of clinical laboratories, GMP-compliant manufacturing facilities, and in-hospital localized application centers, as well as to applications for medical device registration certificates. These initiatives will accelerate the implementation of localized mNGS and LDT solutions, empowering the high-level development of pulmonology departments at regional central hospitals. (VCBeat)

Ancora Health Secures $80 Million in Funding

On the 19th, Ancora Heart announced the completion of an $80 million equity financing. The funds will be used to accelerate the CORCINCH-HF pivotal clinical trial for the AccuCinch Ventricular Restoration System. (Chuangjianhui)

Saiyuan Biotech Completes New Round of Financing

Recently, Saiyuan Biotech announced the completion of a new financing round of tens of millions of RMB. The proceeds will be used to advance the development of its clinical-grade immune cell manufacturing processes and accelerate the R&D of other innovative product pipelines. (Pharma Observer)

Part 3: Pharmaceutical & Medical News

Takeda's Recombinant von Willebrand Factor Meets Primary Endpoint in Phase 3 Clinical Trial

On the 21st, Takeda announced the results of a Phase 3 clinical trial at the ISTH 2021 Congress. The trial was conducted in adult patients with von Willebrand disease to evaluate the efficacy and safety of recombinant von Willebrand factor (trade name: Veyvondi/Vonvendi) for prophylaxis. The results demonstrated that the trial met its primary endpoint of reducing the annualized bleeding rate of spontaneous and treated bleeding events. (Sina Medical News)

Once-Monthly Oral Dosing: Merck’s Long-Acting HIV Prevention Therapy Reports Positive Phase 2 Clinical Results

Merck announced today that its novel nucleoside reverse transcriptase translocation inhibitor, islatravir, achieved positive results in a Phase 2a clinical trial as a pre-exposure prophylaxis therapy. After 24 weeks, once-monthly oral islatravir demonstrated favorable safety and tolerability. Furthermore, eight weeks after receiving the final dose, islatravir levels in the peripheral blood mononuclear cells (PBMCs) of participants remained above the pharmacokinetic threshold required to maintain efficacy. (WuXi AppTec)

Disease-Free Survival Significantly Extended! Study Results on Targeted Adjuvant Therapy for Lung Cancer with Chinese Innovative Drug Announced

Recently, *The Lancet Respiratory Medicine* published the results of the EVIDENCE study on icotinib. The study demonstrated that, following radical surgery in patients with stage II–IIIA EGFR-mutated NSCLC, adjuvant icotinib therapy significantly prolonged disease-free survival and exhibited superior tolerability compared with standard adjuvant chemotherapy. (Medical New Vision)

Excessive Carcinogenic Impurities! Pfizer Recalls 12 Batches of Smoking Cessation Drug Chantix

Recently, Pfizer voluntarily recalled 12 batches of the smoking cessation drug Chantix due to levels of the carcinogenic impurity nitrosamine exceeding the specified acceptable daily intake. Pfizer has currently suspended distribution of Chantix and is accelerating internal testing of the medication. (Sina Pharmaceutical News)

FDA Approves First Drug Therapy for Fatal Pediatric Liver Disease

Albireo Pharma announced today that the U.S. FDA has approved Bylvay (odevixibat). The press release stated that it is the first drug approved for the treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) across all subtypes. (WuXi AppTec)

Tenapanor's Chronic Kidney Disease Indication Faces Market Launch Setback

On the 19th, Ardelyx announced that it had received a feedback letter from the FDA regarding the NDA for a new indication of tenapanor. In the letter, the FDA stated that deficiencies were identified, which preclude discussion of labeling and post-marketing requirements/commitments at this time; however, this does not reflect a final decision on the NDA. Although the specific details of the deficiencies were not disclosed, the FDA indicated that the key issues concern the magnitude of the efficacy benefit and its clinical relevance. (Insight Database)

Klisyri Receives EU Approval for the Treatment of Actinic Keratosis

Almirall S.A. recently announced that the European Commission has approved Klisyri (tirbanibulin) ointment for the topical treatment of actinic keratosis on the face or scalp in adults. (Bioon)

EU Approves Ryeqo for the Treatment of Moderate to Severe Symptoms Associated with Uterine Fibroids

Myovant Sciences recently announced that the European Commission has approved Ryeqo tablets. Administered orally once daily, the drug is indicated for the treatment of moderate to severe symptoms associated with uterine fibroids in women of reproductive age, with no restriction on the duration of treatment. (Bioon)

NMPA Conditionally Approves Azvudine Tablets, a Novel Class 1 Drug for AIDS, for Marketing

On the 21st, the NMPA announced that it has recently granted conditional marketing approval through the priority review and approval procedure for Azvudine Tablets, a Class 1 innovative drug submitted by Realbio. The drug is indicated for use in combination with nucleoside reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors for the treatment of adult patients with HIV-1 infection and high viral load. (NMPA)

Haisco's Fat Emulsion and Amino Acids (17) and Glucose (11%) Injection Approved for Marketing

On the 21st, Haisco announced that its wholly-owned subsidiary, Liaoning Haisco Pharmaceutical Co., Ltd., recently received the 《Drug Registration Certificate》 issued by the NMPA, approving Fat Emulsion (17) Amino Acid (11%) Glucose (11%) Injection for marketing. The product is indicated for adult patients who are unable, have impaired function, or are contraindicated from oral/enteral nutrition intake. (Company Announcement)

Dirui Medical: Amendment to Medical Device Registration Certificates for Two Products

On the 21st, Dirui Medical announced that its vaginal secretion analysis test strips and vaginal secretion dry chemistry analysis quality control materials recently received two “Medical Device Registration Change Documents” issued by the Jilin Provincial Medical Products Administration. The registration change for both products updates the applicable models, now designating them for use with Dirui’s Fully Automated Gynecological Secretion Analysis System and Vaginal Secretion Analyzer. (Corporate Announcement)

Apeloa Pharmaceutical's Wholly-Owned Subsidiary Obtains CEP Certificate for Levofloxacin

On the 21st, Apeloa Pharmaceutical announced that its wholly-owned subsidiary, Apeloa Kangyu Pharmaceutical, received a Certificate of Suitability (CEP) for levofloxacin API issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM). Levofloxacin belongs to the third-generation quinolone class and possesses broad-spectrum antibacterial activity. (Company Announcement)

Haisco's Compound Amino Acid Injection (18AA-VII) Passes Generic Drug Consistency Evaluation

On the 21st, Haisco announced that its wholly-owned subsidiary, Liaoning Haisco Pharmaceutical, recently received the "Notice of Approval for Supplementary Drug Application" issued by the NMPA. Compound Amino Acid Injection (18AA-VII) has passed the generic drug consistency evaluation. It is indicated for supplementing the energy and nutritional components required for the body's daily physiological functions. (Company Announcement)

Innovent Biologics' PD-1 Inhibitor and Ipilimumab Biosimilar Approved for Clinical Trials

On the 20th, the IND application for IBI310 (a biosimilar of ipilimumab) and sintilimab (a PD-1 monoclonal antibody) by Innovent Biologics for the treatment of nasopharyngeal carcinoma was approved. (CDE)

Genor Biopharma's CDK4/6 Inhibitor Approved for Phase III Clinical Trial in Advanced Breast Cancer

On the 20th, Genor Biopharma announced that its GB491 received implied approval for clinical trials from the NMPA, authorizing two Phase III clinical trials for the treatment of breast cancer. (Sina Medicine News)

Shijian Biotech/TopAlliance Biosciences Recombinant Humanized Anti-TROP2 Monoclonal Antibody-SN38 Conjugate Approved for Clinical Trials

According to a CDE announcement, the "Recombinant Humanized Anti-Trop2 Monoclonal Antibody-SN38 Conjugate" submitted by SystImmune has been granted implicit approval for a clinical trial and is intended for development for the treatment of solid tumors. (CDE)

Bristol-Myers Squibb's LAG-3/PD-1 Combination Therapy Approved for Clinical Trials in China

CDE Announcement: Bristol-Myers Squibb's relatlimab/nivolumab fixed-dose combination injection has received implied approval for clinical trials and is intended for development in advanced solid tumors. (CDE)

# Buchang Pharmaceutical’s Wholly-Owned Subsidiary’s Guhong Injection Removed from Provincial Medical Insurance Catalog

On the 21st, Buchang Pharmaceutical announced that Guhong Injection, manufactured by its wholly-owned subsidiary Tonghua Guhong Pharmaceutical, will be delisted from the Hebei Provincial Medical Insurance Catalog on June 30. To ensure uninterrupted medication for insured beneficiaries, a six-month transition period has been established for the delisted drug. The transition period will end on December 31, during which reimbursement will continue in accordance with the original policy. (Corporate Announcement)

Galen Award Shortlist Announced

Today, the Galien Foundation USA announced the nominee list for the 2021 Prix Galien USA. The shortlist includes a record 83 products, all of which have received FDA approval for market launch within the past five years and demonstrate the potential to significantly impact human health. The jury will select the winners in the categories of Best Pharmaceutical Product, Best Biotechnology Product, Best Medical Technology Product, and Best Digital Health Solution. The award winners will be announced on October 28 this year. (WuXi AppTec)