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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 251 drug applications between 5 May 2025 and 11 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 49 drug names.

2025/05/05 – 2025/05/11

Period
2025/05/05 to 2025/05/11, 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
251
Drugs with new generic filings (by drug name, de-duplicated)
49
Accepted this week, now under review
16

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

251filings, 67 of them generic

By application type

Application typeFilings
Supplement121
Generic67
New drug48
Import10
Unspecified5

By drug type

Drug typeFilings
Chemical drug159
TCM49
Therapeutic biologic37
Prophylactic biologic4
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

49 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Penicillin G Sodium For Injection612
2Riociguat Tablets314
3Glucosamine Sulfate Capsules2251
4黄体酮注射液(Ⅱ) · No verified English name222
5Nintedanib Esilate Soft Capsules216
6Carboplatin Injection2110
7Orlistat Capsules218
8Baricitinib Tablets2132
9昂丹司琼口溶膜 · No verified English name212
10Sodium Hyaluronate Eye Drops2130

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

155 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenyang Dong Xin Pharma Co., Ltd. romanized12120
2Jiangxi Qing Feng Pharma Co., Ltd. romanized1090
3Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized660
4AstraZeneca AB650
5Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized650
6Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized616
7Shanxi Huang He Zhong Yao Co., Ltd. romanized550
8Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized530
9Shionogi & Co. Ltd.330
10Shanxi Mai Di Pharmaceutical Co., Ltd. romanized330

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

83 this week

AcceptedDrugApplicants
2025/05/10Import · Class 1 SAR402663注射液 · No verified English nameJXSL2500074 Sanofi-Aventis Recherche & Développement; SANOFI (CHINA) INVESTMENT CO. LTD
2025/05/10Import · Class 1 AZD0780薄膜衣片 · No verified English nameJXHL2500106 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/05/10Generic · Class 3 Diphenhydramine Hydrochloride InjectionCYHS2501704 Anhui Chang Jiang Pharma Co., Ltd. romanized
2025/05/10Generic · Class 3 Ketoconazole CreamCYHS2501702 Bao Long Pharma Co., Ltd. romanized
2025/05/10Generic · Class 3 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2501700 Shijiazhuang Kang Li Pharma Co., Ltd. romanized
2025/05/10Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2501699 Suzhou Hong Sen Pharma Co., Ltd. romanized
2025/05/10Generic · Class 3 Furosemide Oral SolutionCYHS2501698 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2025/05/10Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2501697 Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized
2025/05/10New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2500373 Tianjin Hua Yu Pharma Co., Ltd. romanized
2025/05/10New drug · Class 1 注射用GB268 · No verified English nameCXSL2500372 Jia He Bio Pharma Co., Ltd. romanized
2025/05/10New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2500371 Huan Ke (Hebei) Bio Technology Co., Ltd. romanized; Hua Pu Shijiazhuang Pharmaceuticals Co., Ltd. romanized
2025/05/10New drug · Class 3.3 德谷门冬双胰岛素注射液 · No verified English nameCXSL2500370 Yi Fan Pharmaceuticals (Shanghai) Co., Ltd. romanized
2025/05/10New drug · Class 1 IBI3011 · No verified English nameCXSL2500369 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/05/10New drug · Class 1 玛仕度肽注射液 · No verified English nameCXHL2500459 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/05/10New drug · Class 1 玛仕度肽注射液 · No verified English nameCXHL2500458 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/05/10New drug · Class 1 玛仕度肽注射液 · No verified English nameCXHL2500457 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/05/10New drug · Class 1 DZD8586片 · No verified English nameCXHL2500453 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2025/05/10New drug · Class 1 马来酸苏特替尼胶囊 · No verified English nameCXHL2500452 Jiangsu Mai Du Drug Research and Development Co., Ltd. romanized
2025/05/09Import · Class 3.1 Risankizumab · No verified English nameJXSL2500073 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/05/09Import · Class 2.1 Risankizumab · No verified English nameJXSL2500072 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/05/09Generic · Class 3 Fexofenadine Hydrochloride TabletsCYHS2501681 Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/09Generic · Class 3 Fexofenadine Hydrochloride TabletsCYHS2501680 Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/09New drug · Class 1 注射用RC278 · No verified English nameCXSL2500368 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/05/09New drug · Class 1.2 AFN1204注射液 · No verified English nameCXSL2500367 Hefei A Fa Na Bio Technology Co., Ltd. romanized
2025/05/09New drug · Class 1 IBI130 · No verified English nameCXSL2500366 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/05/09New drug · Class 1.2 AFN1213注射液 · No verified English nameCXSL2500365 Hefei A Fa Na Bio Technology Co., Ltd. romanized
2025/05/09New drug · Class 1 SCTB39-1注射液 · No verified English nameCXSL2500364 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2025/05/09New drug · Class 1 注射用VDJ006 · No verified English nameCXSL2500363 Beijing Wei De Jie Bio Technology Co., Ltd. romanized
2025/05/09New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHS2500045 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/05/09New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHS2500044 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized

53 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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