China Releases 122-Item HGR Regulations and MAH Inspection Guidelines; Major BD Deals by AstraZeneca, Sanofi, Pfizer Highlight Market Momentum

Highlights:

Policy Pharmaceutical News:2022 Government Work Report Released: Strengthening Rare Disease Medication Security, Revitalizing the Development of Traditional Chinese Medicine; 122 Articles, Detailed Regulations on Human Genetic Resources Issued, Clarifying the Definition of Foreign Entities; 50 Inspection Key Points Covering the Entire Life Cycle, NMPA Releases MAH Inspection Key Points (Draft for Comments)...

Market Dynamics:AstraZeneca Reaches $4.4 Billion Collaboration with Swiss Firm; Pfizer Completes $6.7 Billion Acquisition of Arena Pharmaceuticals...

IPO Listing:The First HPV Vaccine Stock on HKEX is Born, Recbio Successfully Listed; RemeGen Officially Listed on STAR Market, Entering a New “A+H” Era...

Major Industry Events:Hengrui Plans Maximum 1.2 Billion Share Repurchase; Pfizer's COVID-19 Oral Drug MPP List Released, Including 5 Chinese Pharmaceutical Companies...

New Drug Development:First China-produced 15-valent HPV vaccine approved for clinical trials; Innovent’s PD-1 overseas IPO rejected by FDA...

Policy and Pharmaceutical News

China's National Health Commission Establishes the Pharmacy Management and Drug Therapy Committee

On March 4, the National Health Commission of China issued the "Notice on the Establishment of the National Health Commission's Pharmacy Administration and Pharmacotherapy Committee." The main responsibilities of this committee include: researching the current status of pharmacy administration in medical institutions in China and providing policy recommendations; offering technical support for establishing and improving systems related to drug selection, procurement, use, and evaluation in medical institutions; promoting the implementation of clinical guidelines and drug application principles related to pharmacotherapy; facilitating the establishment and improvement of China’s pharmaceutical service system, strengthening the construction of the pharmacist workforce, and standardizing and advancing pharmaceutical services; investigating and handling major group adverse drug events; and undertaking other tasks assigned by the National Health Commission of China.

2022 Government Work Report Released, Strengthening the Guarantee of Rare Disease Medications

On March 5, the fifth session of the 13th National People's Congress opened in Beijing. In the new government work report, Premier Li Keqiang of the State Council proposed measures for the pharmaceuticals sector, including advancing centralized procurement of medicines and high-value medical consumables, strengthening the supply guarantee for rare disease medications, regulating medical institution charges and services, supporting the revitalization and development of traditional Chinese medicine (TCM), and promoting comprehensive TCM reform… With regard to the revitalization and development of TCM, on March 29, the General Office of the State Council issued the "14th Five-Year Plan for Traditional Chinese Medicine Development." This is the first five-year plan for TCM issued under the name of the General Office of the State Council. The plan outlines 10 key tasks, sets 15 specific development indicators, and includes 11 work columns.

CDE: Technical Guiding Principles for Protocol Amendments During Drug Clinical Trials (Draft for Public Comment)

On March 11, the Center for Drug Evaluation of the National Medical Products Administration released the "Technical Guiding Principles for Protocol Amendments During Clinical Trials (Draft for Public Comment)" (hereinafter referred to as the draft) for public consultation. The draft focuses on protocol amendments during clinical trials, clarifying the sponsor's main responsibilities, and elaborates on general scenarios and evaluation key points, amendment classifications, amendment procedures, and documentation requirements. These guiding principles are intended to apply to protocol amendments in registration-related clinical trials of traditional Chinese medicine, chemical drugs, biologics, and vaccines, but do not apply to changes in dosage form, route of administration, indications, or additions of combination therapies with other drugs. The deadline for public comments is March 30, 2022.

Detailed Rules of the Human Genetic Resources Regulation Arrive, Clarifying the Reference to Foreign Entities

On March 22, the Ministry of Science and Technology released the "Detailed Implementation Rules of the Regulations on the Administration of Human Genetic Resources (Draft for Soliciting Opinions)" (hereinafter referred to as the "Draft for Soliciting Opinions") for public comments. This is the first time that detailed rules have been introduced since the State Council issued the "Regulations on the Administration of Human Genetic Resources of the People's Republic of China" in 2019. The draft includes 122 detailed provisions, clarifying the qualification recognition of enterprises and international filing cooperation; enterprises with a Variable Interest Entity (VIE) structure can be considered as "foreign entities." Additionally, two key terms—human genes and genomic data—have been added, specifying that human genetic resource information refers to information such as human genes and genomic data generated from human genetic resource materials...

NMPA Releases MAH Inspection Key Points (Draft for Comments)

On March 31, the NMPA released a public solicitation for comments on the "Key Inspection Points for Marketing Authorization Holders of Pharmaceutical Products (Draft for Comments)." The draft outlines inspection requirements across eight areas: general requirements, organization and personnel, production management, material management, quality control and quality assurance, document and record management, sales management, and others—totaling 50 key inspection points covering the entire lifecycle. The deadline for submitting comments is April 30, 2022.

Market Dynamics

Major BD Deals

$4.4 Billion: AstraZeneca Partners with Swiss Company

In early March, Alexion, a subsidiary of AstraZeneca, reached an exclusive global collaboration and licensing agreement with Neurimmune (a Swiss biotech company) for the development of NI006, an antibody-based therapy for treating a rare and underdiagnosed disease that may lead to heart failure. The therapy is currently in Phase 1b clinical trial development. This collaboration is valued at over 4.4 billion yuan. According to the agreement, Neurimmune will receive a $30 million upfront payment, potential milestone payments of up to $730 million, as well as royalties on product sales.

$1 Billion: AbbVie Acquires Syndesi

On March 1, AbbVie announced the acquisition of Syndesi Therapeutics, headquartered in Belgium, for $1 billion, strengthening and expanding AbbVie's neuroscience portfolio. The acquisition includes SDI-118, an early-stage clinical candidate intended to treat cognitive impairments associated with neuropsychiatric and neurodegenerative disorders, which is a novel synaptic vesicle protein 2A (SV2A) modulator, along with its combinations. For this, AbbVie is required to pay Syndesi $130 million upfront, with additional terms obligating AbbVie to potentially pay up to $870 million in future milestone payments.

$2.5 Billion: Sanofi Acquires Pre-Antibody Technology from Adagene

On March 2, Adagene announced a collaboration agreement with Sanofi to develop multiple monoclonal or bispecific antibodies based on Adagene’s SAFEbody single-antibody technology. Under the agreement, Sanofi will pay $17.5 million upfront to initiate the development of two antibody drugs, with the option to select two additional candidate antibodies later. Adagene is eligible to receive up to $2.5 billion in milestone payments as well as a certain percentage of sales royalties.

266 Million Yuan: Porton Pharma Solutions Acquires Chiral Quest

On March 9, Chongqing Porton Pharmaceutical Technology Co., Ltd. plans to acquire 100% of the equity of Caremax Pharmaceutical (Shanghai) Co., Ltd., held by Shanghai ChemPartner Co., Ltd., for a cash consideration of RMB 266 million. Upon completion of this transaction, the company will hold 100% of Caremax Pharmaceutical's equity, making it a wholly-owned subsidiary, and it will be included in the company’s consolidated financial statements.

$6.7 Billion: Pfizer Officially Acquires Arena Pharmaceuticals

On March 11, Pfizer announced the completion of its acquisition of Arena Pharmaceuticals for a total transaction value of approximately $6.7 billion. Through this acquisition, Pfizer gained access to Arena's oral S1P receptor modulator etrasimod, as well as other pipeline drugs such as Temanogrel and APD418. Etrasimod is currently in Phase III trials for the treatment of ulcerative colitis, Crohn's disease, and atopic dermatitis, with Phase II trials ongoing for eosinophilic esophagitis and alopecia areata. Temanogrel is in Phase II development for the treatment of microvascular obstruction secondary to systemic sclerosis and Raynaud’s phenomenon. APD418 has also entered Phase II clinical trials for the treatment of acute heart failure.

Over $6 Billion: IGM Collaborates with Sanofi to Develop IgM Antibody Therapy

On March 29, Sanofi and IGM Biosciences announced a collaboration. IGM will use its IgM platform to continue developing IgM antibody therapies targeting three oncology targets and three immunology/inflammation targets. Under the agreement, IGM will receive an upfront payment of $150 million, with potential milestone payments of up to $940 million for each oncology target and up to $1.065 billion for each immunology/inflammation target. For the oncology collaboration, IGM will be responsible for development until obtaining regulatory approval from the FDA or EMA, while Sanofi will handle subsequent product development and commercialization. For the immunology/inflammation collaboration, IGM will oversee development through Phase I clinical trials, after which Sanofi will take over further development.

IPO Listing

Lepu Medical Plans to List on the Swiss Stock Exchange

On March 16, LePu Medical announced that, according to the resolution of the board of directors, the company plans to list on the Swiss Stock Exchange. By leveraging overseas capital, it aims to promote the research, registration, and commercialization of its cardiovascular device products abroad, further expanding overseas markets. Additionally, it plans to establish overseas production bases to implement its international development strategy. However, whether this issuance can obtain the aforementioned approvals, verifications, or filings, as well as the exact timing of obtaining them, remains uncertain. It faces risks due to the international environment, market conditions, financing timing, regulatory issues, or other reasons.

The First HPV Vaccine Stock on HKEX, Recbio Successfully Listed

On March 31, Recbio successfully went public on the Hong Kong Stock Exchange, becoming the first HPV stock on the Hong Kong Stock Exchange. Recbio has currently established a portfolio of 12 candidate vaccines. In addition to the HPV series of vaccines, Recbio's R&D pipeline also includes vaccines with significant market potential such as COVID-19 vaccines, herpes zoster vaccines, and influenza vaccines. Among them, the recombinant HPV nine-valent vaccine REC603 is already in phase III clinical trials and is expected to become the first domestically produced HPV nine-valent vaccine in China.

Rongchang Bio科创板上市，开启“A+H”新时代

On March 31, Rongchang Bio officially listed on the STAR Market, achieving dual listing in "A+H" shares. It is reported that Rongchang Bio publicly issued 54,426,301 shares at an issue price of 48 yuan per share. After the issuance, the total share capital reached 544,263,003 shares, with a total fundraising amount of 2.61 billion yuan. The funds will be used for new drug industrialization, development of new anti-tumor antibody drugs, autoimmune and ophthalmic antibody drug research, as well as replenishing operational funds.

Major Corporate Events

Hengrui Plans to Repurchase Shares for Up to 1.2 Billion Yuan

On March 13, Hengrui Medicine announced that it plans to repurchase shares worth between 600 million yuan and 1.2 billion yuan. The repurchased shares will be used for employee stock ownership plans or equity incentives. The repurchase will be conducted through centralized bidding transactions on the secondary market. The total amount of repurchase funds will depend on the actual funds used at the end of the repurchase period. Based on a maximum repurchase fund of 1.2 billion yuan and a maximum repurchase price of 60.22 yuan per share, the estimated number of shares to be repurchased is approximately 19.9269 million, accounting for about 0.31% of the company's current total share capital.

Pfizer's COVID-19 Treatment Drug Included in Medical Insurance

On March 21, the National Healthcare Security Administration issued the "Notice on Effectively Doing the Current Medical Security Work for Epidemic Prevention and Control." The notice mentioned the timely adjustment of COVID-19 treatment drugs covered by medical insurance payments. For the newly added Paxlovid (Nirmatrelvir/Ritonavir) in the "Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9)," medical institutions will procure it at a price agreed upon by enterprises and relevant departments, with the healthcare security department responsible for payment as per regulations. Its price is set at 2,300 yuan per box, with the country’s first procurement totaling more than 21,000 boxes.

35 Pharmaceutical Companies Can Manufacture Pfizer's COVID-19 Oral Drug for Free

Geneva's Medicines Patent Pool (MPP) announced that it has signed agreements with 35 pharmaceutical companies allowing them to produce nirmatrelvir, one of the key components of Pfizer’s new oral drug Paxlovid, as an active pharmaceutical ingredient (API) or in formulation. Among these 35 companies, six will focus on producing the API, nine will be responsible for manufacturing the formulation, and the remaining 20 enterprises will produce both API and formulation. Notably, five of the 35 companies are Chinese enterprises: Bloomage Biotech and Jiuzhou Pharma were approved to manufacture the API, while Desano Pharma, Huahai Pharma, and Fosun Pharma were authorized to produce both API and formulation.

MSD and Moderna Terminate mRNA Cancer Vaccine Collaboration

In its 2021 annual report, Moderna, Inc. disclosed that it had regained all rights to the KRAS-targeted cancer vaccine mRNA-5671 from Merck & Co., Inc. The mRNA-5671 is an mRNA vaccine delivered via lipid nanoparticles, encoding four mutant antigens of KRAS: G12D, G12V, G13D, and G12C. Currently, this project has progressed to Phase I clinical trials for the development of treatments for non-small cell lung cancer, colorectal cancer, and pancreatic cancer. However, Merck & Co., Inc. and Moderna are still collaborating on another personalized cancer vaccine, mRNA-4157, which can encode up to 34 tumor neoantigens.

New Drug Development

First China-produced 15-valent HPV vaccine approved for clinical trials

On March 16, the CDE website announced that the clinical trial application for the recombinant fifteen-valent human papillomavirus vaccine (Escherichia coli) co-developed by Chengda Biological and CanSino Biologics was approved. This is the HPV vaccine candidate with the highest valency currently under research globally. It is intended for females aged 9-45 and aims to prevent persistent infections caused by HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68, as well as cervical cancer, vulvar cancer, vaginal cancer, and anal cancer induced by these infections; genital warts caused by HPV6 and HPV11; and the following lesions caused by HPV types 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68: cervical intraepithelial neoplasia (CIN1/2/3), adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN2/3), vaginal intraepithelial neoplasia (VaIN2/3), anal intraepithelial neoplasia (AIN1/2/3), and other related diseases.

China's First Approved PI3K Inhibitor Launched

On March 18, CSPC Pharmaceutical Group's PI3Kδ/γ inhibitor Duvanlisib Capsules (trade name: Kerblis) was approved for marketing in China, becoming the first approved PI3K inhibitor in the country. It is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/rFL) who have received at least two prior systemic therapies.

First LAG-3 Therapy Approved by FDA for Market Launch

On March 18, Bristol-Myers Squibb (BMS) announced that its first-in-class dual immunotherapy, Relatlimab + Nivolumab fixed-dose combination Opdualag, received accelerated FDA approval for the treatment of metastatic melanoma. This marks the first FDA-approved LAG3 antibody combination therapy, making LAG3 the third immune checkpoint to be applied clinically after PD-1 and CTLA-4.

Innovent PD-1 Overseas Launch Rejected by FDA

On March 24, Innovent Biologics announced that the company had received a complete response letter from the FDA regarding the review of the marketing application for sintilimab. The result was consistent with the decision previously made by the Oncologic Drugs Advisory Committee. The FDA recommended supplementing head-to-head standard therapy (i.e., Keytruda), with a non-inferiority, global multi-center Phase III clinical trial using overall survival (OS) as the primary endpoint. The FDA requested that sintilimab increase clinical research in the U.S. and did not recommend direct approval.

Source: CDE, National Medical Products Administration, corporate announcements, Pharma Intelligence Network, Pharma R&D, E-Pharma Manager, Finance & Health, and other public information.

Editor: Sanqi

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