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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 333 drug applications between 7 May 2025 and 13 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 87, covering 60 drug names.

2025/05/07 – 2025/05/13

Period
2025/05/07 to 2025/05/13, 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
333
Drugs with new generic filings (by drug name, de-duplicated)
60
Accepted this week, now under review
30

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

333filings, 87 of them generic

By application type

Application typeFilings
Supplement161
Generic87
New drug60
Import19
Unspecified5
Import re-registration1

By drug type

Drug typeFilings
Chemical drug203
TCM67
Therapeutic biologic57
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

60 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
5氯雷他定糖浆 · No verified English name227
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

197 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 AB960
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
7Sanofi Winthrop Industrie610
8Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized616
9Shanxi Huang He Zhong Yao Co., Ltd. romanized550
10Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized540

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

112 this week

AcceptedDrugApplicants
2025/05/13Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2500060 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2025/05/13Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2500059 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2025/05/13Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2500058 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2025/05/13Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2500057 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2025/05/13Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2500056 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2025/05/13Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2500055 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2025/05/13Import · Class 2.4 Capivasertib片 · No verified English nameJXHL2500109 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2025/05/13Import · Class 2.4 Capivasertib片 · No verified English nameJXHL2500108 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2025/05/13Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2501720 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/05/13Generic · Class 3 Nalbuphine Hydrochloride InjectionCYHS2501717 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2025/05/13Generic · Class 3 Nalbuphine Hydrochloride InjectionCYHS2501716 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2025/05/13Generic · Class 3 Brivaracetam Oral SolutionCYHL2500091 Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized
2025/05/13New drug · Class 1 注射用重组巴曲酶 · No verified English nameCXSS2500050 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized
2025/05/13New drug · Class 1 SYS6026注射液 · No verified English nameCXSL2500376 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/05/13New drug · Class 2.4 舒沃替尼片 · No verified English nameCXHL2500462 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2025/05/13New drug · Class 2.4 舒沃替尼片 · No verified English nameCXHL2500461 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
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

82 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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