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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 293 drug applications between 19 June 2025 and 25 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 88, covering 56 drug names.

2025/06/19 – 2025/06/25

Period
2025/06/19 to 2025/06/25, 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
293
Drugs with new generic filings (by drug name, de-duplicated)
56
Accepted this week, now under review
53

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

293filings, 88 of them generic

By application type

Application typeFilings
Supplement129
Generic88
New drug47
Import18
Import re-registration7
Unspecified4

By drug type

Drug typeFilings
Chemical drug177
TCM65
Therapeutic biologic48
Prophylactic biologic2
Biologic1

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

56 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

209 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Amgen Inc.720
2Novo Nordisk A/S510
3Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized444
4Roche Pharma (Schweiz) AG420
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized410
6Shanghai He Huang Pharma Co., Ltd. romanized330
7Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized330
8Hunan Tai Yang Pharma Co., Ltd. romanized330
9Tong Hua Ji Tong Pharma Co., Ltd. romanized330
10Pfizer Inc.320

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

85 this week

AcceptedDrugApplicants
2025/06/25Import · Class 2.2; 2.4 利福布汀注射用浓溶液 · No verified English nameJXHL2500153 BioVersys AG; GuangZhou BioVersys Pharmaceutical Co. Ltd
2025/06/25Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2502273 Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2025/06/25Generic · Class 3 米拉贝隆缓释干混悬剂 · No verified English nameCYHL2500121 Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized
2025/06/25New drug · Class 1 IMS001注射液 · No verified English nameCXSL2500514 Zhuhai Heng Qin Ai Mu Si Tan Bio Technology Co., Ltd. romanized
2025/06/25New drug · Class 1 AXT-1003胶囊 · No verified English nameCXHL2500618 Ai Si Tuo Kang Pharmaceuticals Technology (Beijing) Co., Ltd. romanized
2025/06/24Import · Class 1 U3-1402 · No verified English nameJXSL2500112 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2025/06/24Import · Class 1 PF-08046054 (注射用冻干粉针) · No verified English nameJXSL2500111 Pfizer Inc.; Pfizer Investment CO. Ltd.
2025/06/24Import · Class 1 ALPN-303注射液 · No verified English nameJXSL2500110 Vertex Pharmaceuticals Incorporated; Name not romanized
2025/06/24Generic · Class 3 Ebastine Oral SolutionCYHS2502258 Ren Xi Pharmaceuticals Technology Hebei Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2025/06/24Generic · Class 3 Bilastine Oral SolutionCYHS2502257 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/06/24Generic · Class 3 Sucralfate Oral SuspensionCYHS2502256 Hefei Guo Gao Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized
2025/06/24New drug · Class 1 GR2303注射液 · No verified English nameCXSL2500512 Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2025/06/24New drug · Class 1 TQH2722注射液 · No verified English nameCXSL2500511 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/06/24New drug · Class 1 ALMB-0166注射液 · No verified English nameCXSL2500510 Shanghai En Le Mai Bio Technology Co., Ltd. romanized
2025/06/24New drug · Class 3.2 流感病毒裂解疫苗(高剂量) · No verified English nameCXSL2500509 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2025/06/24New drug · Class 1 TQC2731注射液 · No verified English nameCXSL2500508 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/06/24New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2500069 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2025/06/24New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2500068 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2025/06/24New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2500617 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/06/24New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2500616 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/06/24New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2500615 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/06/24New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2500614 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/06/24New drug · Class 1 BT01001滴眼液 · No verified English nameCXHL2500613 Suzhou Bi Yang Pharmaceuticals Technology Co., Ltd. romanized
2025/06/24New drug · Class 1 BT01001滴眼液 · No verified English nameCXHL2500612 Suzhou Bi Yang Pharmaceuticals Technology Co., Ltd. romanized
2025/06/24New drug · Class 1 BT01001滴眼液 · No verified English nameCXHL2500611 Suzhou Bi Yang Pharmaceuticals Technology Co., Ltd. romanized
2025/06/24New drug · Class 1 ICP-248片 · No verified English nameCXHL2500610 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2025/06/24New drug · Class 1 ICP-248片 · No verified English nameCXHL2500609 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
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

55 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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