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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 587 drug applications between 17 September 2026 and 23 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 64 drug names.

2026/09/17 – 2026/09/23

Period
2026/09/17 to 2026/09/23, 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
587
Drugs with new generic filings (by drug name, de-duplicated)
64
Accepted this week, now under review
483

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

587filings, 93 of them generic

By application type

Application typeFilings
Supplement321
New drug100
Generic93
Import36
Unspecified19
Import re-registration18

By drug type

Drug typeFilings
Chemical drug304
TCM164
Therapeutic biologic106
Biologic11
Prophylactic 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

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ruxolitinib Phosphate Tablets4127
2盐酸西替利嗪滴眼液 · No verified English name333
3Ertugliflozin Tablets3313
4Brimonidine Tartrate Eye Drops334
5Baricitinib Tablets3232
6Oseltamivir Phosphate Capsules3139
7Mupirocin Ointment3130
8瑞维那新吸入溶液 · No verified English name2253
9Fruquintinib Capsules214
10Sildenafil Citrate Tablets2112

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

338 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Kang Nuo Ya Biopharmaceuticals Co., Ltd. romanized1210
2Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized1120
3Janssen-Cilag International NV1030
4Ji Chuan (Shanghai) Yi Xue Technology Co., Ltd. romanized920
5Bayer Vital GmbH910
6Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized720
7Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized550
8Xian Wan Long Pharmaceutical Co., Ltd. romanized550
9Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized540
10Jiangsu Lian Huan Zhong Yao Co., Ltd. romanized530

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

148 this week

AcceptedDrugApplicants
2026/09/23Import · Class 1 Bimagrumab注射液 · No verified English nameJXSL2600259 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/09/23Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600258 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/09/23Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600257 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/09/23Import · Class 2.4 塞普替尼片 · No verified English nameJXHS2600121 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/09/23Import · Class 2.4 塞普替尼片 · No verified English nameJXHS2600120 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/09/23Import · Class 2.4 塞普替尼片 · No verified English nameJXHS2600119 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/09/23Import · Class 2.4 塞普替尼片 · No verified English nameJXHS2600118 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/09/23Import · Class 1 BI 3034701注射液 · No verified English nameJXHL2600416 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/09/23Import · Class 1 BI 3034701注射液 · No verified English nameJXHL2600415 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/09/23Import · Class 1 BI 3034701注射液 · No verified English nameJXHL2600414 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/09/23Import · Class 1 BI 3034701注射液 · No verified English nameJXHL2600413 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/09/23Import · Class 1 BI 3034701注射液 · No verified English nameJXHL2600412 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/09/23Generic · Class 3 Cefazolin Sodium for InjectionCYHS2602400 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2026/09/23Generic · Class 3 Potassium Aspartate InjectionCYHS2602398 Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized
2026/09/23Generic · Class 3 盐酸西替利嗪滴眼液 · No verified English nameCYHS2602394 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2026/09/23Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2602391 Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized
2026/09/23New drug · Class 3.1 温经汤颗粒 · No verified English nameCXZS2600052 Jiangxi Yao Dou Zhang Shu Pharmaceutical Co., Ltd. romanized
2026/09/23New drug · Class 1.1 巴芪柔肝颗粒 · No verified English nameCXZL2600094 Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized; Ji Chuan (Shanghai) Yi Xue Technology Co., Ltd. romanized
2026/09/23New drug · Class 1 注射用HLX49 · No verified English nameCXSL2601056 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2026/09/23New drug · Class 1 RG002-02注射液 · No verified English nameCXSL2601055 Ren Jing (Suzhou) Bio Technology Co., Ltd. romanized; Zhongguo Yi Xue Ke College Pharmaceuticals Bio Technology Research Institute romanized
2026/09/23New drug · Class 3.3 依柯胰岛素注射液 · No verified English nameCXSL2601054 Tong Hua Dong Bao Pharma Co., Ltd. romanized
2026/09/23New drug · Class 1.1 猴痘mRNA疫苗 · No verified English nameCXSL2601053 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/09/23New drug · Class 1 注射用Efimosfermin alfa · No verified English nameCXSL2601052 Ge Lan Su Shi Ke (Zhongguo) Investment Co., Ltd. romanized
2026/09/23New drug · Class 2.2 氢溴酸伏硫西汀口崩片 · No verified English nameCXHS2600136 Fuzhou Zhang Fu Xing Biopharmaceuticals Technology Co., Ltd. romanized; Xiamen En Cheng Pharmaceutical Co., Ltd. romanized
2026/09/23New drug · Class 2.3 BTP4106 · No verified English nameCXHL2601199 Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized
2026/09/23New drug · Class 1 OST11098片 · No verified English nameCXHL2601198 Hefei Sheng Rui Ze Hua Pharmaceuticals Technology Co., Ltd. romanized
2026/09/23New drug · Class 1 OST11098片 · No verified English nameCXHL2601197 Hefei Sheng Rui Ze Hua Pharmaceuticals Technology Co., Ltd. romanized
2026/09/23New drug · Class 1 ASP5834注射液 · No verified English nameCXHL2601196 An Si Tai Lai (Beijing) Pharmaceuticals Research and Development Co., Ltd. romanized
2026/09/23New drug · Class 2.4 氨酚羟考酮缓释片 · No verified English nameCXHL2601195 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2026/09/22Import · Class 1 MK-7240注射液 · No verified English nameJXSL2600256 Merck Sharp & Dohme LLC; Name not romanized

118 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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