YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 621 drug applications between 9 October 2026 and 15 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 110, covering 71 drug names.

2026/10/09 – 2026/10/15

Period
2026/10/09 to 2026/10/15, 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
621
Drugs with new generic filings (by drug name, de-duplicated)
71
Accepted this week, now under review
547

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

621filings, 110 of them generic

By application type

Application typeFilings
Supplement313
New drug132
Generic110
Import29
Unspecified19
Import re-registration18

By drug type

Drug typeFilings
Chemical drug332
TCM161
Therapeutic biologic119
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

71 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

359 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Pfizer Inc.920
2Dong E E Jiao Co., Ltd. romanized880
3Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized820
4N. V. Organon810
5Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized770
6Boehringer Ingelheim International GmbH710
7Guangxi Bao Rui Tan Pharmaceutical Co., Ltd. romanized640
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
9AbbVie Inc.620
10Upjohn Manufacturing Ireland Unlimited Company610

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

206 this week

AcceptedDrugApplicants
2026/10/15Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHS2602548 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2026/10/15New drug · Class 3.1 芍药甘草汤颗粒 · No verified English nameCXZS2600054 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2026/10/15New drug · Class 1.1 金菊消痤颗粒 · No verified English nameCXZL2600100 Chongqing Xi Er An Pharma Co., Ltd. romanized
2026/10/15New drug · Class 3.3 13价肺炎球菌多糖结合疫苗 · No verified English nameCXSS2600165 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized
2026/10/15New drug · Class 3.3 13价肺炎球菌多糖结合疫苗 · No verified English nameCXSS2600164 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized
2026/10/15New drug · Class 1 DS001注射用冻干粉针 · No verified English nameCXSL2601134 Hangzhou Da Mai Bio Technology Co., Ltd. romanized
2026/10/15New drug · Class 1 HS-20169注射液 · No verified English nameCXSL2601133 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/10/15New drug · Class 1 注射用MCLA-129 · No verified English nameCXSL2601132 Bei Da Pharma Co., Ltd. romanized
2026/10/15New drug · Class 1 注射用BGB-B2033 · No verified English nameCXSL2601131 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2026/10/15New drug · Class 1 AI-081注射液 · No verified English nameCXSL2601130 Nanjing Ang Ke Mian Yi Biopharmaceuticals Co., Ltd. romanized
2026/10/15New drug · Class 1 AI-081注射液 · No verified English nameCXSL2601129 Nanjing Ang Ke Mian Yi Biopharmaceuticals Co., Ltd. romanized
2026/10/15New drug · Class 1 LY-M001 注射液 · No verified English nameCXSL2601128 Ling Yi (Hangzhou) Bio Technology Co., Ltd. romanized
2026/10/15New drug · Class 1 RH125注射液 · No verified English nameCXSL2601127 Wuhan Rui Ji Bio Technology Co., Ltd. romanized; Shenzhen Rui Ji Bio Technology Co., Ltd. romanized
2026/10/15New drug · Class 1.4 31价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2601126 Shandong Kun Li Biopharmaceutical Co., Ltd. romanized
2026/10/15New drug · Class 1 注射用BC602 · No verified English nameCXSL2601125 Bao Chuan Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/10/15New drug · Class 1 BPI-572270胶囊 · No verified English nameCXHL2601293 Hangzhou Jing Yao Bio Technology Co., Ltd. romanized
2026/10/15New drug · Class 1 BPI-572270胶囊 · No verified English nameCXHL2601292 Hangzhou Jing Yao Bio Technology Co., Ltd. romanized
2026/10/15New drug · Class 1 BPI-572270胶囊 · No verified English nameCXHL2601291 Hangzhou Jing Yao Bio Technology Co., Ltd. romanized
2026/10/15New drug · Class 1 IN10018片 · No verified English nameCXHL2601290 Ying Shi Bio Technology (Shenzhen) Co., Ltd. romanized
2026/10/15New drug · Class 1 IN10018片 · No verified English nameCXHL2601289 Ying Shi Bio Technology (Shenzhen) Co., Ltd. romanized
2026/10/15New drug · Class 1 ART104注射液 · No verified English nameCXHL2601288 Suzhou Ang Tuo Biopharmaceuticals Co., Ltd. romanized
2026/10/15New drug · Class 1 FY105注射液 · No verified English nameCXHL2601287 Beijing Foyou Pharma CO.,LTD
2026/10/15New drug · Class 1 TLL-041片 · No verified English nameCXHL2601286 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2026/10/15New drug · Class 1 TLL-041片 · No verified English nameCXHL2601285 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2026/10/15New drug · Class 1 YH601软膏 · No verified English nameCXHL2601284 Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized
2026/10/15New drug · Class 1 YH601软膏 · No verified English nameCXHL2601283 Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized
2026/10/14Import · Class 2.2 来瑞奇珠单抗注射液(皮下注射) · No verified English nameJXSS2600095 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/10/14Generic · Class 3 Fexofenadine Hydrochloride Oral SuspensionCYHS2602547 Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized
2026/10/14Generic · Class 3 Ketoprofen PatchesCYHS2602542 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized; Hunan Pai Ge Lan Pharma Co., Ltd. romanized
2026/10/14Generic · Class 3 Ketoprofen PatchesCYHS2602541 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized; Hunan Pai Ge Lan Pharma Co., Ltd. romanized

176 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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