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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 179 drug applications between 3 May 2025 and 9 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 37 drug names.

2025/05/03 – 2025/05/09

Period
2025/05/03 to 2025/05/09, 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
179
Drugs with new generic filings (by drug name, de-duplicated)
37
Accepted this week, now under review
9

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

179filings, 51 of them generic

By application type

Application typeFilings
Supplement80
Generic51
New drug38
Import8
Unspecified2

By drug type

Drug typeFilings
Chemical drug122
Therapeutic biologic29
TCM23
Prophylactic biologic3
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

37 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
4Orlistat Capsules218
5Baricitinib Tablets2132
6昂丹司琼口溶膜 · No verified English name212
7Sodium Hyaluronate Eye Drops2130
8Nicardipine Hydrochloride Injection2113
9Fexofenadine Hydrochloride Tablets2110
10Minoxidil Liniment2152

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

120 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
5Shanxi Mai Di Pharmaceutical Co., Ltd. romanized330
6Shijiazhuang No.4 Pharmaceutical Co., Ltd.332
7AstraZeneca AB320
8Hangzhou Da Ge Biopharmaceuticals Technology Co., Ltd. romanized310
9Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized310
10Hefei A Fa Na Bio Technology 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

65 this week

AcceptedDrugApplicants
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
2025/05/09New drug · Class 1 DEG6498胶囊 · No verified English nameCXHL2500456 Hangzhou Da Ge Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/09New drug · Class 1 DEG6498胶囊 · No verified English nameCXHL2500455 Hangzhou Da Ge Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/09New drug · Class 1 DEG6498胶囊 · No verified English nameCXHL2500454 Hangzhou Da Ge Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/09New drug · Class 2.2 X004口服溶液 · No verified English nameCXHL2500450 Beijing Hai Yi Pharma Co., Ltd. romanized
2025/05/09New drug · Class 2.2 KLA318-2纳米晶注射液 · No verified English nameCXHL2500449 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/05/09New drug · Class 1 注射用JJH201601脂质体 · No verified English nameCXHL2500448 Jiangsu Ji Bei Er Pharma Co., Ltd. romanized
2025/05/09New drug · Class 1 炔丙基半胱氨酸胶囊 · No verified English nameCXHL2500447 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized
2025/05/09New drug · Class 1 炔丙基半胱氨酸胶囊 · No verified English nameCXHL2500446 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized
2025/05/09New drug · Class 1 NB001片 · No verified English nameCXHL2500445 Zhejiang Yong Zhan Pharmaceuticals Technology Co., Ltd. romanized
2025/05/09New drug · Class 1 NB001片 · No verified English nameCXHL2500444 Zhejiang Yong Zhan Pharmaceuticals Technology Co., Ltd. romanized
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

35 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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