Pharmaceutical Updates
AstraZeneca Voluntarily Applies to Lower the Procurement Listing Price of Sodium Zirconium Cyclosilicate for Oral Suspension
On July 1, according to the Liaoning Provincial Pharmaceutical Procurement Network, AstraZeneca voluntarily applied to lower the listed procurement price of sodium zirconium cyclosilicate powder from 486 RMB to 340.2 RMB, representing a 30% price reduction. The product was approved for import in China in January 2020, becoming the country's first innovative drug launched for hyperkalemia.
In 2020, sodium zirconium cyclosilicate for oral suspension also participated in the national healthcare insurance negotiation and appeared on the list of drugs that passed the formal review published by the National Healthcare Security Administration. However, it ultimately failed to be included in the National Reimbursement Drug List, possibly due to pricing or other factors. Since its market launch, this new drug has maintained a price of RMB 486. This voluntary price reduction signals proactive preparation for the next round of healthcare insurance negotiations. (Source: Insight Database)
Abogen Biosciences Completes China’s First GMP-Compliant mRNA Vaccine Manufacturing Facility
On July 1, Abogen announced the completion of China's first GMP-compliant mRNA vaccine production facility. Reportedly, the facility is located in Suzhou and is expected to achieve an annual production capacity of 40 million single doses.
In June 2020, the ARCoV vaccine successfully obtained China's first clinical trial approval for an mRNA vaccine, achieving a breakthrough from zero to one for the nation's mRNA vaccine development. Reports indicate that the vaccine can be stored at 2°C to 8°C for at least six months, and remains stable for up to 7 days at room temperature, significantly mitigating the challenges associated with cold chain transportation.
Alphamab Oncology’s Envafolimab Receives Additional FDA Orphan Drug Designation
On July 1, Alphamab Oncology announced that its independently developed PD-L1 monoclonal antibody, envafolimab (KN035), has been granted Orphan Drug Designation by the FDA for the treatment of soft tissue sarcoma. Notably, this marks the second Orphan Drug Designation for envafolimab, following its previous designation for advanced biliary tract cancer. Currently, the marketing authorization application for envafolimab in China has been included in the priority review program by the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA), with a commercial launch expected in the second half of this year.
NMPA Accepts Akeso’s Marketing Authorization Application for Penpulimab as First-Line Treatment for Squamous Non-Small Cell Lung Cancer
On July 2, Akeso announced that a marketing application for penpulimab, a PD-1 monoclonal antibody co-developed with China National Biotec Group, in combination with chemotherapy for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer, has been submitted to and accepted by the National Medical Products Administration (NMPA). This marks the third marketing application successfully submitted for penpulimab, following the submission of a Biologics License Application (BLA) in the United States under the Real-Time Oncology Review (RTOR) pilot program for the third-line treatment of metastatic nasopharyngeal carcinoma, and the submission of a New Drug Application (NDA) in China for the treatment of relapsed or refractory classical Hodgkin lymphoma after at least two prior lines of systemic chemotherapy.
Roche Plans to Submit Marketing Application to FDA for Alzheimer’s Disease Drug Candidate
According to investment bank Jefferies, Roche held a meeting with the FDA last week. Following the meeting, internal teams are actively preparing to submit a marketing application for gantenerumab, with expectations of securing accelerated approval in Q1 2022. It is reported that gantenerumab was originally developed by MorphoSys. After Roche secured the licensing rights, the company conducted multiple clinical trials. Despite repeated setbacks, Roche has persisted by continuously adjusting trial protocols to advance development, and Phase III clinical trials remain ongoing. (Source: Pharma Notes)
Financing & Collaboration
GemPharmatech Plans STAR Market IPO
On June 30, the IPO prospectus of GemPharmatech, a model animal CXO enterprise, was publicly disclosed for listing on the STAR Market. The company plans to raise RMB 820 million, accounting for no more than 10% of the total share capital post-issuance, implying a market capitalization of over RMB 8.2 billion at issuance. RMB 600 million of the proceeds will be allocated to the construction of an integrated R&D and breeding base for model mice.
Currently, the niche segment for model animals in China is not yet crowded. In addition to GemPharmatech and Nanmo Bioscience, which are in the process of listing on the STAR Market, the field has also been entered by Vital River, a joint venture in China of the American CRO Charles River Laboratories, as well as Biocytogen, which proposed the "Thousand Mice, Ten Thousand Antibodies" program. (Source: STAR Market Daily)
Allist Pharmaceuticals' Third-Generation EGFR-TKI Secures Overseas Licensing Deal Worth Over $800 Million
On June 30, Allist announced that it intends to enter into the *Global Technology Transfer and License Agreement* and the *Common Stock Purchase Agreement* with ArriVent Biopharma, establishing a comprehensive partnership for the overseas development and commercialization of the third-generation EGFR-TKI, furmonertinib mesylate. Under this collaboration, Allist will receive a $40 million upfront payment and an equity stake in ArriVent, along with up to $765 million in regulatory and commercial milestone payments, as well as double-digit sales royalties. ArriVent will secure exclusive rights to develop and commercialize furmonertinib in overseas markets (global territories excluding mainland China, Hong Kong, Macau, and Taiwan).
Clinical Specialty Testing Leader Kindstar Global Plans to List on HKEX
On June 29, Kindstar Global, the first independent clinical specialty testing service provider in China, launched its initial public offering. The offer price range for the new shares is HK$8.60 to HK$9.78. The company plans a global offering of 226 million shares, comprising approximately 22.6405 million shares for the Hong Kong offering and about 203.8 million shares for the international offering, aiming to raise up to HK$2.542 billion. Goldman Sachs, CICC, and Credit Suisse act as joint sponsors. The company is expected to finalize the offer price on July 8 and list on the Hong Kong Stock Exchange on July 16 under the stock code 09960.HK.
According to a Frost & Sullivan report, based on 2019 revenue, Concord Healthcare Group holds a 42% market share in China's independent advanced hematology testing market, ranking first, and is also one of the companies globally capable of providing the most comprehensive hematology testing portfolio. (Source: IPO Early Know)
Beihai Kancheng Lists in Hong Kong
On June 30, Canbridge Life Sciences formally filed its prospectus with the Hong Kong Stock Exchange for a proposed Main Board listing, with Morgan Stanley and Jefferies acting as joint sponsors. Founded in 2012, the company specializes in the rare disease sector and is dedicated to the research, development, and commercialization of transformative therapies.
As of the Latest Practicable Date, Canbridge Pharmaceuticals has developed a comprehensive and differentiated pipeline comprising 13 drug assets with significant market potential, targeting some of the most common rare diseases and rare oncology indications, including three marketed products, three clinical-stage candidates, two IND-enabling candidates, two preclinical-stage candidates, and three gene therapy products at the lead identification stage. (Source: IPO Zaozhidao)
Policy
On June 30, the National Healthcare Security Administration officially released the "Work Plan for the 2021 Adjustment of the National Reimbursable Drug List" and the "Application Guidelines for the 2021 Adjustment of the National Reimbursable Drug List", marking the official commencement of the 2021 drug list adjustment process. According to official statements, the adjustment work is scheduled to be completed by the end of this year, with the aim of implementing the updated list starting in January next year.
The plan states that four categories of products are eligible to apply for medical insurance negotiations: new drugs approved between January 1, 2016 and June 30, 2021; drugs with significant changes in indications or therapeutic functions; drugs for the treatment of respiratory diseases related to COVID-19; and drugs included in the 《National Essential Medicine List (2018 Edition)》. This is undoubtedly good news for domestic innovative drugs.