YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 334 drug applications between 15 June 2025 and 21 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 107, covering 75 drug names.

2025/06/15 – 2025/06/21

Period
2025/06/15 to 2025/06/21, 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
334
Drugs with new generic filings (by drug name, de-duplicated)
75
Accepted this week, now under review
63

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

334filings, 107 of them generic

By application type

Application typeFilings
Supplement144
Generic107
New drug43
Import34
Unspecified4
Import re-registration2

By drug type

Drug typeFilings
Chemical drug195
TCM72
Therapeutic biologic65
Prophylactic biologic2

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

75 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

217 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Amgen Inc.1420
2Novo Nordisk A/S820
3Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized555
4Shijiazhuang No.4 Pharmaceutical Co., Ltd.554
5Lai Yang Si Bang De Pharmaceutical Co., Ltd. romanized550
6Yunnan Jin Ke Pharmaceutical Co., Ltd. romanized540
7Pfizer Inc.530
8Huayi Pharmaceuticals (Anhui) Co., Ltd.535
9Wen Zhou Hai He Pharma Co., Ltd. romanized430
10Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized424

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

108 this week

AcceptedDrugApplicants
2025/06/21Import · Class 1 AMG 133 · No verified English nameJXSL2500109 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/21Import · Class 1 AMG 133 · No verified English nameJXSL2500108 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/21Import · Class 1 AMG 133 · No verified English nameJXSL2500107 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/21Import · Class 1 AMG 133 · No verified English nameJXSL2500106 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/21Import · Class 1 AMG 133 · No verified English nameJXSL2500105 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/21Import · Class 1 AMG 133 · No verified English nameJXSL2500104 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/21Import · Class 1 AZD8205 · No verified English nameJXSL2500103 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/06/21Generic · Class 3 小儿多种维生素注射液(13) · No verified English nameCYHS2502241 Ya Bao Pharma Group Co., Ltd. romanized
2025/06/21Generic · Class 3 比拉斯汀口崩片 · No verified English nameCYHS2502229 Sichuan Kelun Pharmaceutical Co., Ltd.
2025/06/21Generic · Class 3 Elagolix TabletsCYHL2500118 Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized
2025/06/21Generic · Class 3 Elagolix TabletsCYHL2500117 Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized
2025/06/21Generic · Class 3 Levothyroxine Sodium Oral SolutionCYHL2500116 Jiangsu Bei Mei Pharmaceutical Co., Ltd. romanized
2025/06/21New drug · Class 1 T3011疱疹病毒注射液 · No verified English nameCXSL2500502 Suzhou Yi Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2025/06/21New drug · Class 1 CX1440胶囊 · No verified English nameCXHL2500603 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2025/06/21New drug · Class 1 CX1440胶囊 · No verified English nameCXHL2500602 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2025/06/21New drug · Class 1 HSK47388片 · No verified English nameCXHL2500601 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2025/06/21New drug · Class 1 HSK47388片 · No verified English nameCXHL2500600 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
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

78 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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