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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 594 drug applications between 4 February 2026 and 10 February 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 92, covering 63 drug names.

2026/02/04 – 2026/02/10

Period
2026/02/04 to 2026/02/10, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
594
Drugs with new generic filings (by drug name, de-duplicated)
63
Accepted this week, now under review
148

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

594filings, 92 of them generic

By application type

Application typeFilings
Supplement374
Generic92
New drug81
Import re-registration18
Import17
Unspecified12

By drug type

Drug typeFilings
Chemical drug289
TCM229
Therapeutic biologic67
Biologic6
Prophylactic biologic3

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

63 drugs with new generic filings; top 10 listed

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

243 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized123950
2Ha Yao Group Bio Gong Cheng Co., Ltd. romanized38190
3Jiangxi Pu Li Er Pharma Co., Ltd. romanized27260
4Jiangsu Hao Sen Pharma Group Co., Ltd. romanized1220
5Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized1080
6AstraZeneca AB950
7Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized880
8Guangzhou Wan Yi Te Medical Yong Pin Co., Ltd. romanized850
9Ai Min Pharma Group Co., Ltd. romanized550
10PHARMATHEN INVESTMENTS GROUP LIMITED510

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

128 this week

AcceptedDrugApplicants
2026/02/10Import · Class 1 JNJ-79635322 · No verified English nameJXSL2600041 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/02/10Import · Class 1 JNJ-79635322 · No verified English nameJXSL2600040 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/02/10Import · Class 1 JNJ-79635322 · No verified English nameJXSL2600039 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/02/10Import · Class 1 JNJ-79635322 · No verified English nameJXSL2600038 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/02/10Import · Class 1 TQJ230注射液 · No verified English nameJXHL2600037 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/02/10Import · Class 1 BIIB115注射液 · No verified English nameJXHL2600036 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2026/02/10Generic · Class 3 Fosphenytoin Sodium InjectionCYHS2600430 Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2026/02/10Generic · Class 3 Fosphenytoin Sodium InjectionCYHS2600429 Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2026/02/10Generic · Class 3 Arformoterol Tartrate Inhalation SolutionCYHS2600423 HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2026/02/10Generic · Class 3 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2600419 Hunan Jiudian Pharmaceutical Co., Ltd
2026/02/10Generic · Class 3 Tetracaine Hydrochloride GelCYHS2600418 Shanghai Zhao Hui Pharma Co., Ltd. romanized
2026/02/10Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2600417 Jiangsu Shen Hua Pharma Co., Ltd. romanized
2026/02/10Generic · Class 3 Furosemide Oral SolutionCYHS2600415 Guizhou Qian Yao Group Pharmaceutical Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanized
2026/02/10Generic · Class 3 醋酸地非法林注射液 · No verified English nameCYHL2600022 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2026/02/10New drug · Class 2.2 重组人血管内皮抑制素注射液 · No verified English nameCXSS2600017 Shandong Xian Sheng Zai Ming Biopharmaceutical Co., Ltd. romanized
2026/02/10New drug · Class 1 注射用PCNAT-01 · No verified English nameCXSL2600201 An Da Bio Drug Kai Fa (Beijing) Co., Ltd. romanized
2026/02/10New drug · Class 2.2 埃诺格鲁肽注射液 · No verified English nameCXSL2600200 Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized
2026/02/10New drug · Class 2.2 埃诺格鲁肽注射液 · No verified English nameCXSL2600199 Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized
2026/02/10New drug · Class 1 CPU-YL01注射液 · No verified English nameCXSL2600198 Jiangsu Chuang Yuan Sheng Ming Technology Co., Ltd. romanized; Zhongguo Yao Ke University romanized
2026/02/10New drug · Class 1 EA5注射液皮下制剂 · No verified English nameCXSL2600196 Shanghai Lan Yi Pharmaceuticals Technology Co., Ltd. romanized
2026/02/10New drug · Class 1 SG301 SC注射液 · No verified English nameCXSL2600195 Hangzhou Shang Jian Bio Technology Co., Ltd. romanized
2026/02/10New drug · Class 1 CG001注射液 · No verified English nameCXSL2600194 Shanghai Kang Jing Biopharmaceuticals Technology Co., Ltd. romanized
2026/02/10New drug · Class 1 ZHB118舌下片 · No verified English nameCXSL2600193 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2026/02/10New drug · Class 1.4 四价重组手足口病疫苗(毕赤酵母) · No verified English nameCXSL2600192 Chongqing Hua Zhi Biopharmaceutical Co., Ltd. romanized; Hua Song (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized
2026/02/10New drug · Class 1 SSS68注射液 · No verified English nameCXSL2600191 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/02/10New drug · Class 1 ZHB118舌下片 · No verified English nameCXSL2600190 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2026/02/10New drug · Class 1 SSS68注射液 · No verified English nameCXSL2600189 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/02/10New drug · Class 1 SSS68注射液 · No verified English nameCXSL2600188 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/02/10New drug · Class 1 醋酸索乐匹尼布片 · No verified English nameCXHS2600027 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/02/10New drug · Class 2.4 TXA-070片 · No verified English nameCXHL2600168 Wuhan Ke Fu Xin Yao Co., Ltd. romanized

98 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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