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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 289 drug applications between 6 May 2025 and 12 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 52 drug names.

2025/05/06 – 2025/05/12

Period
2025/05/06 to 2025/05/12, 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
289
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
23

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

289filings, 76 of them generic

By application type

Application typeFilings
Supplement139
Generic76
New drug56
Import12
Unspecified5
Import re-registration1

By drug type

Drug typeFilings
Chemical drug181
TCM59
Therapeutic biologic43
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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Minoxidil Liniment6352
2Penicillin G Sodium For Injection612
3Riociguat Tablets314
4Brexpiprazole Tablets3131
5Glucosamine Sulfate Capsules2251
6黄体酮注射液(Ⅱ) · No verified English name222
7Nintedanib Esilate Soft Capsules216
8Carboplatin Injection2110
9Orlistat Capsules218
10Baricitinib Tablets2132

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

171 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
3AstraZeneca AB760
4Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized660
5Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized650
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
7Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized616
8Shanxi Huang He Zhong Yao Co., Ltd. romanized550
9Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized530
10Shaanxi Pan Long Pharma Group Co., Ltd. romanized440

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

97 this week

AcceptedDrugApplicants
2025/05/12Import · Class 3.1 司库奇尤单抗注射液 · No verified English nameJXSS2500054 Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Novartis Pharmaceutical Manufacturing GmbH; Beijing Novartis Pharma Co. Ltd.
2025/05/12Import · Class 1 AZD9833片 · No verified English nameJXHL2500107 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2025/05/12Generic · Class 3 Minoxidil LinimentCYHS2501714 Guangdong Ke Hong Pharma Co., Ltd. romanized
2025/05/12Generic · Class 3 Minoxidil LinimentCYHS2501713 Guangdong Ke Hong Pharma Co., Ltd. romanized
2025/05/12Generic · Class 3 Minoxidil LinimentCYHS2501712 Shandong Nuo Ming Kang Drug Research Institute Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized
2025/05/12Generic · Class 3 Minoxidil LinimentCYHS2501711 Shandong Nuo Ming Kang Drug Research Institute Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized
2025/05/12New drug · Class 1 EXG202注射液 · No verified English nameCXSL2500375 Hangzhou Jia Yin Bio Technology Co., Ltd. romanized
2025/05/12New drug · Class 1 自体天然肿瘤浸润淋巴细胞注射液 · No verified English nameCXSL2500374 Shanghai Jun Sai Bio Pharma Co., Ltd. romanized; Shanghai Jun Sai Bio Technology Co., Ltd. romanized
2025/05/12New drug · Class 1 索托克拉片 · No verified English nameCXHS2500050 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/05/12New drug · Class 1 索托克拉片 · No verified English nameCXHS2500049 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/05/12New drug · Class 1 索托克拉片 · No verified English nameCXHS2500048 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/05/12New drug · Class 1 索托克拉片 · No verified English nameCXHS2500047 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/05/12New drug · Class 1 盐酸吉卡昔替尼片 · No verified English nameCXHS2500046 Name not romanized
2025/05/12New drug · Class 1 SP-101注射液 · No verified English nameCXHL2500460 Si Lai Pu Tai (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized
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

67 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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