中国 in 会談 with Pfizer for generic COVID 麻薬 - sources

By Julie Zhu and Kevin Huang

HONG KONG/BEIJING, Jan 6 (Reuters) - 中国 is in 会談 with Pfizer Inc to 安全な・保証する a licence that will 許す 国内の drugmakers to 製造(する) and 分配する a generic 見解/翻訳/版 of the U.S. 会社/堅い's COVID-19 antiviral 麻薬 Paxlovid in 中国, three sources told Reuters.

中国's 医療の 製品s regulator - the 国家の 医療の 製品s 行政 (NMPA) - has been 主要な the 会談 with Pfizer since late last month, one of the sources with knowledge of the 事柄 said.

Beijing is keen to finalise licensing 取引,協定 条件 before the Lunar New Year which begins on Jan. 22, the source said.

Chinese hospitals are under 激しい 圧力 after the 政府 突然の abandoned its "無-COVID" 政策 last month, sending 感染s 急に上がるing. The 殺到するing wave of 感染s across the country has 圧倒するd hospitals, emptied pharmacies of 薬/医学s and 原因(となる)d international alarm.

Paxlovid, 設立する to have 減ずるd hospitalisations in high-危険 患者s by around 90% in a 臨床の 裁判,公判, is in high 需要・要求する with many Chinese 試みる/企てるing to get the 麻薬 abroad and have it shipped to 中国. Beijing has been 大部分は 抵抗力のある to western ワクチンs and 治療s. Oral 治療 Paxlovid is one of the few foreign ones it has 認可するd.

In February last year, 中国 認可するd Paxlovid, which was supposed to be 大部分は 利用できる 経由で hospitals, to 扱う/治療する high-危険 患者s in several 州s. Pfizer last month reached an 協定 to 輸出(する) Paxlovid to 中国 through a 地元の company to make the 薬/医学 more 広範囲にわたって 利用できる.

The NMPA and the 明言する/公表する 会議 (警察などへの)密告,告訴(状) Office, which 扱うs マスコミ queries for the 政府, did not 答える/応じる to Reuters requests for comment.

A Pfizer spokesperson said the company is 活発に 共同製作 with Chinese 当局 and all stakeholders to 安全な・保証する an 適する 供給(する) of Paxlovid in 中国.

All the sources 拒絶する/低下するd to be identified as they are not authorised to speak to マスコミ.

The NMPA held a 会合 with several Chinese drugmakers in late December to discuss 準備s needed to make a generic 見解/翻訳/版 of Paxlovid hoping it would be able to 安全な・保証する the licence in the 近づく 未来, two of the sources said.

Zhejiang Huahai 製薬の, which 調印するd a を取り引きする Pfizer in August to produce Paxlovid only for use on the 本土/大陸, and CSPC 製薬の Group, a developer of a 可能性のある mRNA COVID ワクチン, are の中で those that …に出席するd the 会合, the first source said.

The second source said the NMPA has also advised 会社/堅いs to 準備する to 登録(する) with the regulator to produce the generic 見解/翻訳/版 of Paxlovid.

GENERIC DRUGMAKERS

見込みのある 候補者s 含むing Huahai and CSPC have in 最近の weeks been 行為/行うing "bioequivalence 実験(する)s", which are 要求するd by Chinese regulators before generic 麻薬s can be 開始する,打ち上げるd, the two sources and another source with direct knowledge of the 事柄 said.

For a generic 麻薬 to be みなすd 同等(の) to a branded 薬/医学, such 実験(する)s are 要求するd to make sure they work the same way in the 団体/死体.

Both Huahai and CSPC 推定する/予想する to 服従させる/提出する the 実験(する)s results to the NMPA later this month, one of them 追加するd.

Huahai and CSPC did not 答える/応じる to a request for comment.

In March, 35 generic drugmakers around the world 含むing five Chinese 会社/堅いs agreed to make cheap 見解/翻訳/版s of Paxlovid for 95 poorer countries through a licensing 協定 with the U.N.-支援するd 薬/医学s 特許 Pool (MPP). That licence does not 許す the companies to sell generic Paxlovid in 中国.

The MPP licensing 協定 is 王族 解放する/自由な for Pfizer, while COVID-19 remains 分類するd as a "Public Health 緊急 of International 関心" by the World Health Organization (世界保健機構).

に引き続いて the pandemic period, sales to low-income countries will remain 王族 解放する/自由な, lower-middle-income countries and upper-middle-income countries will be 支配する to a 5% 王族 for sales to the public 部門 and a 10% 王族 for sales to the 私的な 部門, MPP said at that time.

予定 to 厳しい 不足s of antivirals as 1.4 billion Chinese 戦う/戦い 感染s, many have turned to 地下組織の channels to 安全な・保証する Paxlovid and other 麻薬s, によれば 国内の マスコミ. Scalpers 告発(する),告訴(する)/料金 as much as 50,000 yuan ($7,260) for a box of Paxlovid, more than 20 times its 初めの price of 2,300 yuan.

中国 has also 圧力(をかける)d Pfizer to lower the price of Paxlovid as the 政府 目的(とする)s to 含む the 麻薬 in the 国家の 医療の 保険 計画/陰謀 which could cover part of the cost, the three sources said.

($1 = 6.8875 Chinese yuan) (報告(する)/憶測ing by Julie Zhu in Hong Kong and Kevin Huang in Beijing; 付加 報告(する)/憶測ing by Michael Erman in New York; Editing by Sumeet Chatterjee and Jacqueline Wong)

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