YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 369 drug applications between 17 June 2025 and 23 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 120, covering 81 drug names.

2025/06/17 – 2025/06/23

Period
2025/06/17 to 2025/06/23, 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
369
Drugs with new generic filings (by drug name, de-duplicated)
81
Accepted this week, now under review
69

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

369filings, 120 of them generic

By application type

Application typeFilings
Supplement155
Generic120
New drug53
Import34
Unspecified4
Import re-registration3

By drug type

Drug typeFilings
Chemical drug216
TCM81
Therapeutic biologic70
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

81 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

235 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

122 this week

AcceptedDrugApplicants
2025/06/23Generic · Class 3 Lysine Acetylsalicylate For InjectionCYHS2502249 Nanjing Huang Long Bio Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2025/06/23Generic · Class 3 Lysine Acetylsalicylate For InjectionCYHS2502248 Nanjing Huang Long Bio Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2025/06/23Generic · Class 3 Prasugrel Hydrochloride TabletsCYHL2500120 Chongqing Pharmaceuticals (Group) Co., Ltd. romanized
2025/06/23Generic · Class 3 Prasugrel Hydrochloride TabletsCYHL2500119 Chongqing Pharmaceuticals (Group) Co., Ltd. romanized
2025/06/23New drug · Class 1 异体人成纤维细胞注射液 · No verified English nameCXSL2500513 Chui Yuan Yi Xue Technology (Shanghai) Co., Ltd. romanized
2025/06/23New drug · Class 1 VUM02注射液 · No verified English nameCXSL2500507 Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized
2025/06/23New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500506 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/06/23New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2500505 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/06/23New drug · Class 1 注射用SHR-1826 · No verified English nameCXSL2500504 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/06/23New drug · Class 1 HS-10241片 · No verified English nameCXHL2500608 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2025/06/23New drug · Class 1 HS-10241片 · No verified English nameCXHL2500607 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2025/06/23New drug · Class 1 JMKX003002片 · No verified English nameCXHL2500606 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2025/06/23New drug · Class 1 JMKX003002片 · No verified English nameCXHL2500605 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2025/06/23New drug · Class 1 JMKX003002片 · No verified English nameCXHL2500604 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
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

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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.