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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 124 drug applications between 2 May 2025 and 8 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 34, covering 24 drug names.

2025/05/02 – 2025/05/08

Period
2025/05/02 to 2025/05/08, 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
124
Drugs with new generic filings (by drug name, de-duplicated)
24
Accepted this week, now under review
8

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

124filings, 34 of them generic

By application type

Application typeFilings
Supplement63
Generic34
New drug20
Import6
Unspecified1

By drug type

Drug typeFilings
Chemical drug82
Therapeutic biologic21
TCM19
Biologic1
Prophylactic 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

24 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Penicillin G Sodium For Injection612
2Glucosamine Sulfate Capsules2251
3黄体酮注射液(Ⅱ) · No verified English name222
4Baricitinib Tablets2132
5昂丹司琼口溶膜 · No verified English name212
6Minoxidil Liniment2152
7中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English name117
8Diacerein Capsules113
9噻托溴铵吸入粉雾剂 · No verified English name112
10Empagliflozin Tablets1118

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

85 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized660
2Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized650
3Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized616
4Shanxi Huang He Zhong Yao Co., Ltd. romanized550
5AstraZeneca AB320
6Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized310
7Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized220
8Shijiazhuang No.4 Pharmaceutical Co., Ltd.221
9Kui Hua Pharma Group Hubei Wu Dang Co., Ltd. romanized221
10Chongqing Mei Sha Pharma Co., Ltd. romanized220

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

43 this week

AcceptedDrugApplicants
2025/05/08Import · Class 3.1 注射用卡普赛珠单抗 · No verified English nameJXSS2500053 Ablynx NV; Patheon Italia S.p.A.; Sanofi (China) Investment Co. Ltd.
2025/05/08Import · Class 3.4 人血白蛋白 · No verified English nameJXSS2500052 CSL Behring (Australia) Pty Ltd
2025/05/08Import · Class 1 Depemokimab注射液 · No verified English nameJXSL2500071 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2025/05/08Import · Class 1 Liafensine片 · No verified English nameJXHL2500105 Denovo Biopharma LLC; Denovo Biopharma Co. Ltd.
2025/05/08Generic · Class 3 Minoxidil LinimentCYHS2501671 Changsha Innovation Drug Gong Ye Technology Research Institute Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized
2025/05/08Generic · Class 3 Minoxidil LinimentCYHS2501670 Changsha Innovation Drug Gong Ye Technology Research Institute Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized
2025/05/08Generic · Class 3 黄体酮注射液(Ⅱ) · No verified English nameCYHS2501666 Beijing Liu Huan Pharma Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2025/05/08Generic · Class 3 黄体酮注射液(Ⅱ) · No verified English nameCYHS2501665 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2025/05/08Generic · Class 3 昂丹司琼口溶膜 · No verified English nameCYHS2501664 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/05/08Generic · Class 3 昂丹司琼口溶膜 · No verified English nameCYHS2501663 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/05/08Generic · Class 3 Penicillin G Sodium For InjectionCYHS2501661 Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized
2025/05/08Generic · Class 3 Penicillin G Sodium For InjectionCYHS2501660 Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized
2025/05/08Generic · Class 3 Penicillin G Sodium For InjectionCYHS2501658 Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized
2025/05/08Generic · Class 3 Penicillin G Sodium For InjectionCYHS2501657 Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized
2025/05/08Generic · Class 3 Penicillin G Sodium For InjectionCYHS2501656 Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized
2025/05/08Generic · Class 3 Penicillin G Sodium For InjectionCYHS2501655 Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized
2025/05/08Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2501654 Hubei Wu Shi Pharma Co., Ltd. romanized
2025/05/08Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2501653 Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2025/05/08Generic · Class 3 索法酮颗粒 · No verified English nameCYHS2501652 Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2025/05/08Generic · Class 3 Propranolol hydrochloride oral solutionCYHS2501650 Hubei Min Kang Pharmaceutical Co., Ltd. romanized
2025/05/08New drug · Class 1 注射用DB-1305 · No verified English nameCXSL2500362 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/05/08New drug · Class 1 注射用DB-1311 · No verified English nameCXSL2500361 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/05/08New drug · Class 1 重组抗VEGF人源化单克隆抗体注射液 · No verified English nameCXSL2500360 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2025/05/08New drug · Class 1 重组抗VEGF人源化单克隆抗体注射液 · No verified English nameCXSL2500359 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2025/05/08New drug · Class 1 注射用BG-C477 · No verified English nameCXSL2500358 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2025/05/08New drug · Class 3.3 艾美赛珠单抗注射液 · No verified English nameCXSL2500357 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2025/05/08New drug · Class 3.3 艾美赛珠单抗注射液 · No verified English nameCXSL2500356 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2025/05/08New drug · Class 1 NTS071片 · No verified English nameCXHL2500451 Shanghai Yu Dao Bio Technology Co., Ltd. romanized
2025/05/08New drug · Class 1 RK-4注射液 · No verified English nameCXHL2500443 Fuzhou Ning Dan Rong Kang Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/07Import · Class 2.2 TARA-002 · No verified English nameJXSL2500070 Protara Therapeutics Inc.; Syneos Health(Beijing)Inc. Ltd.

13 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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