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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 124 drug applications between 1 May 2025 and 7 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 27, covering 25 drug names.

2025/05/01 – 2025/05/07

Period
2025/05/01 to 2025/05/07, 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)
25
Accepted this week, now under review
6

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, 27 of them generic

By application type

Application typeFilings
Supplement68
Generic27
New drug25
Import3
Import re-registration1

By drug type

Drug typeFilings
Chemical drug91
Therapeutic biologic17
TCM16

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

25 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Benidipine Hydrochloride Tablets224
2Baricitinib Tablets2132
3中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English name117
4二甲双胍恩格列净片(Ⅰ) · No verified English name117
5厄贝沙坦氢氯噻嗪片 · No verified English name115
6噻托溴铵吸入粉雾剂 · No verified English name112
7Brexpiprazole Tablets1131
8Fluvastatin Sodium Extended Release Tablets116
9Sacubitril Valsartan Sodium Tablets1170
10注射用阿立哌唑 · No verified English name114

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

82 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenyang Dong Xin Pharma Co., Ltd. romanized880
2Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized660
3Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized540
4Guangdong Sunho Pharmaceutical Co., Ltd.510
5Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized410
6Hunan Ke Lun Pharmaceutical Co., Ltd. romanized320
7Janssen-Cilag International NV310
8Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized310
9Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized310
10Shijiazhuang No.4 Pharmaceutical Co., Ltd.221

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

32 this week

AcceptedDrugApplicants
2025/05/07Import · Class 2.2 TARA-002 · No verified English nameJXSL2500070 Protara Therapeutics Inc.; Syneos Health(Beijing)Inc. Ltd.
2025/05/07Generic · Class 3 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2501645 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/05/07New drug · Class 1 重组抗CD19m-CD3抗体注射液 · No verified English nameCXSL2500355 Tian Mai Yuan He Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2025/05/07New drug · Class 1 LP-005 注射液 · No verified English nameCXSL2500354 Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2025/05/07New drug · Class 3.4 注射用重组凝血因子Ⅷ(猪序列) · No verified English nameCXSL2500353 Zhuang Ya (Beijing) Bio Technology Co., Ltd. romanized
2025/05/07New drug · Class 1 FG-B901注射液 · No verified English nameCXSL2500352 Ming Ji Biopharmaceutical (Beijing) Co., Ltd. romanized
2025/05/07New drug · Class 3.3 HWS111注射液 · No verified English nameCXSL2500351 Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized
2025/05/07New drug · Class 1 CMS-D001片 · No verified English nameCXHL2500442 Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized
2025/05/07New drug · Class 1 CMS-D001片 · No verified English nameCXHL2500441 Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized
2025/05/07New drug · Class 1 CMS-D001片 · No verified English nameCXHL2500440 Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized
2025/05/07New drug · Class 1 纳米氧化铁注射液 · No verified English nameCXHL2500439 Suzhou Xin Ying Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/07New drug · Class 2.2 YH2201干混悬剂 · No verified English nameCXHL2500438 Zhejiang Yi Han Pharmaceutical Co., Ltd. romanized
2025/05/07New drug · Class 2.2 YH2201干混悬剂 · No verified English nameCXHL2500437 Zhejiang Yi Han Pharmaceutical Co., Ltd. romanized
2025/05/06Import · Class 2.4 Tacrolimus Eye DropsJXHL2500104 SENJU PHARMACEUTICAL CO. LTD.; Name not romanized
2025/05/01Import · Class 1 177Lu-HuJ591单抗注射液 · No verified English nameJXSL2500069 Telix Pharmaceuticals (Innovations) Pty Ltd; GrandPharma (China) Co. Ltd.
2025/05/01Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2501638 Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized
2025/05/01Generic · Class 3 Meloxicam injectionCYHS2501635 Zhejiang Sheng Zhao Drug Technology Co., Ltd. romanized; Hangzhou Ao Ya Bio Technology Co., Ltd. romanized
2025/05/01Generic · Class 3 Sodium Thiosulfate InjectionCYHS2501634 Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2025/05/01New drug · Class 1 FL115注射液 · No verified English nameCXSL2500350 Suzhou Fu Rong Bio Technology Co., Ltd. romanized
2025/05/01New drug · Class 1 BAT4406F注射液 · No verified English nameCXSL2500349 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2025/05/01New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2500348 Shenzhen Shi Bei Ke Bio Technology Co., Ltd. romanized
2025/05/01New drug · Class 1 注射用BGB-B3227 · No verified English nameCXSL2500347 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2025/05/01New drug · Class 1 注射用重组病毒巨噬细胞炎性蛋白 · No verified English nameCXSL2500346 Guangzhou Hong Run Bio Technology Co., Ltd. romanized
2025/05/01New drug · Class 2.2 依沃西单抗注射液 · No verified English nameCXSL2500345 Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized
2025/05/01New drug · Class 1 注射用HRS8179 · No verified English nameCXHL2500436 Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/05/01New drug · Class 1 MDI-1228_mesylate凝胶 · No verified English nameCXHL2500435 Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized
2025/05/01New drug · Class 1 MDI-1228_mesylate凝胶 · No verified English nameCXHL2500434 Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized
2025/05/01New drug · Class 1 MDI-1228_mesylate凝胶 · No verified English nameCXHL2500433 Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized
2025/05/01New drug · Class 1 MDI-1228_mesylate凝胶 · No verified English nameCXHL2500432 Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized
2025/05/01New drug · Class 1 HRS-1893片 · No verified English nameCXHL2500431 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized

2 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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