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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 409 drug applications between 14 June 2025 and 20 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 115, covering 85 drug names.

2025/06/14 – 2025/06/20

Period
2025/06/14 to 2025/06/20, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
409
Drugs with new generic filings (by drug name, de-duplicated)
85
Accepted this week, now under review
71

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

409filings, 115 of them generic

By application type

Application typeFilings
Supplement193
Generic115
New drug53
Import37
Unspecified8
Import re-registration3

By drug type

Drug typeFilings
Chemical drug250
TCM85
Therapeutic biologic67
Biologic4
Prophylactic biologic3

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

85 drugs with new generic filings; top 10 listed

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

248 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan Ying Feng Pharmaceuticals Co., Ltd. romanized880
2Amgen Inc.820
3Novo Nordisk A/S820
4Pfizer Inc.740
5Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized555
6Shijiazhuang No.4 Pharmaceutical Co., Ltd.554
7Lai Yang Si Bang De Pharmaceutical Co., Ltd. romanized550
8Yunnan Jin Ke Pharmaceutical Co., Ltd. romanized540
9Huayi Pharmaceuticals (Anhui) Co., Ltd.535
10Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized510

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

122 this week

AcceptedDrugApplicants
2025/06/20Generic · Class 3 Sodium Nitroprusside InjectionCYHS2502228 Guangzhou Shi Ji Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/06/20Generic · Class 3 Benzbromarone TabletsCYHS2502226 Zhejiang Hua Hai Pharmaceutical Technology Co., Ltd. romanized
2025/06/20Generic · Class 3 氨基酸(15)腹膜透析液 · No verified English nameCYHS2502220 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/06/20Generic · Class 3 丙酸氟替卡松吸入粉雾剂 · No verified English nameCYHS2502219 Run Sheng Pharma Co., Ltd. romanized
2025/06/20Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2502216 Fu Yuan Pharma Co., Ltd. romanized
2025/06/20Generic · Class 3 Sodium Nitroprusside InjectionCYHS2502213 Hainan Brilliant Pharmaceutical Co., Ltd.
2025/06/20New drug · Class 1 CM336注射液 · No verified English nameCXSL2500503 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2025/06/20New drug · Class 1 多抗原自体免疫细胞注射液 · No verified English nameCXSL2500501 Heng Rui Yuan Zheng (Shanghai) Bio Technology Co., Ltd. romanized
2025/06/20New drug · Class 1 磷酸泊沃昔替尼片 · No verified English nameCXHL2500599 Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized
2025/06/20New drug · Class 1 磷酸泊沃昔替尼片 · No verified English nameCXHL2500598 Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized
2025/06/20New drug · Class 1 磷酸泊沃昔替尼片 · No verified English nameCXHL2500597 Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized
2025/06/20New drug · Class 1 BAY 3713372 片 · No verified English nameCXHL2500596 Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized
2025/06/20New drug · Class 1 BAY 3713372 片 · No verified English nameCXHL2500595 Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized
2025/06/20New drug · Class 2.2; 2.4 FCZR · No verified English nameCXHL2500594 Bo Ji Pharmaceuticals Technology Co., Ltd. romanized
2025/06/20New drug · Class 2.2; 2.4 FCZR · No verified English nameCXHL2500593 Bo Ji Pharmaceuticals Technology Co., Ltd. romanized
2025/06/20New drug · Class 1 YH004胶囊 · No verified English nameCXHL2500592 Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized
2025/06/19Import · Class 2.4 紫杉醇口服溶液 · No verified English nameJXHS2500073 DAEHWA PHARMACEUTICAL CO.,LTD.; Haihe Biopharma Co. Ltd
2025/06/19Import · Class 2.4 紫杉醇口服溶液 · No verified English nameJXHS2500072 DAEHWA PHARMACEUTICAL CO.,LTD.; Haihe Biopharma Co. Ltd
2025/06/19Import · Class 2.4 紫杉醇口服溶液 · No verified English nameJXHS2500071 DAEHWA PHARMACEUTICAL CO.,LTD.; Haihe Biopharma Co. Ltd
2025/06/19Import · Class 1 Centanafadine持释胶囊 · No verified English nameJXHL2500152 Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Institute
2025/06/19Import · Class 1 Centanafadine持释胶囊 · No verified English nameJXHL2500151 Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Institute
2025/06/19Import · Class 1 Centanafadine持释胶囊 · No verified English nameJXHL2500150 Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Institute
2025/06/19Generic · Class 3 Foscarnet Sodium InjectionCYHS2502204 Hainan Ru Kang Bio Technology Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2025/06/19New drug · Class 3.3 SYS6036注射液 · No verified English nameCXSL2500500 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/06/19New drug · Class 1 HX001注射液 · No verified English nameCXSL2500499 Wuhan Hou Xian Biopharmaceuticals Co., Ltd. romanized
2025/06/19New drug · Class 1 丁二酸复瑞替尼胶囊 · No verified English nameCXHL2500591 Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized
2025/06/19New drug · Class 2.2 雷美替胺双释片 · No verified English nameCXHL2500590 Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized
2025/06/18Import · Class 2.2 DS-1062a · No verified English nameJXSL2500102 Daiichi Sankyo Inc.
2025/06/18Import · Class 2.2 注射用德曲妥珠单抗 · No verified English nameJXSL2500101 Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2025/06/18Import · Class 2.2 比奇珠单抗注射液 · No verified English nameJXSL2500100 UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd

92 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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