YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 261 drug applications between 24 September 2026 and 30 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 39, covering 34 drug names.

2026/09/24 – 2026/09/30

Period
2026/09/24 to 2026/09/30, 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
261
Drugs with new generic filings (by drug name, de-duplicated)
34
Accepted this week, now under review
218

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

261filings, 39 of them generic

By application type

Application typeFilings
Supplement136
New drug50
Generic39
Import24
Import re-registration9
Unspecified3

By drug type

Drug typeFilings
Chemical drug138
TCM81
Therapeutic biologic40
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

34 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

173 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Pfizer Inc.1630
2Jiangxi Pin Xin Pharma Co., Ltd. romanized630
3Mian Yang Yi Kang Pharmaceutical Co., Ltd. romanized550
4Shanxi Wang Long Pharma Group Co., Ltd. romanized440
5Shaanxi Ou Ke Pharma Co., Ltd. romanized440
6Anhui Zhang Heng Chun Pharma Co., Ltd. romanized330
7Gansu Xin Min Hai Pharmaceutical Co., Ltd. romanized330
8Shen Wei Pharma Group Co., Ltd. romanized330
9Yunnan Zhi Wu Pharma Co., Ltd. romanized320
10Hangzhou Du Yi Technology Co., Ltd. romanized320

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

92 this week

AcceptedDrugApplicants
2026/09/30Import · Class 2.2 伊奈利珠单抗注射液 · No verified English nameJXSL2600262 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/09/30Generic · Class 3 Acetylcysteine TabletsCYHS2602434 Guangdong Sai Kang Pharmaceutical Factory Co., Ltd. romanized
2026/09/30Generic · Class 3 Levofloxacin InjectionCYHS2602433 Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2026/09/30New drug · Class 1 注射用AST1001 · No verified English nameCXSL2601080 Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized
2026/09/30New drug · Class 1 RG002-03注射液 · No verified English nameCXSL2601079 Ren Jing (Suzhou) Bio Technology Co., Ltd. romanized; Zhongguo Yi Xue Ke College Pharmaceuticals Bio Technology Research Institute romanized
2026/09/30New drug · Class 1 ALXN2220注射液 · No verified English nameCXSL2601078 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized
2026/09/30New drug · Class 1 SI-B037双特异性抗体注射液 · No verified English nameCXSL2601077 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/09/30New drug · Class 2.2; 2.4 BTS1115 · No verified English nameCXHL2601220 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
2026/09/30New drug · Class 1 SPR2015片 · No verified English nameCXHL2601219 Shanghai Si Pu Rui Pharmaceuticals Technology Co., Ltd. romanized
2026/09/30New drug · Class 1 SPR2015片 · No verified English nameCXHL2601218 Shanghai Si Pu Rui Pharmaceuticals Technology Co., Ltd. romanized
2026/09/30New drug · Class 1 HJY-39注射液 · No verified English nameCXHL2601217 Xiamen Gan Bao Li Biopharmaceuticals Co., Ltd. romanized
2026/09/29Import · Class 1 PF-07994525 · No verified English nameJXHL2600435 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/09/29Import · Class 1 PF-07994525 · No verified English nameJXHL2600434 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/09/29Import · Class 1 PF-07994525 · No verified English nameJXHL2600433 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/09/29Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600432 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/09/29Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600431 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/09/29Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600430 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/09/29Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600429 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/09/29Generic · Class 3 Calcitriol Oral SolutionCYHS2602431 Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized
2026/09/29Generic · Class 3 Hydrotalcite SuspensionCYHS2602427 Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; Shaanxi Han Jiang Pharma Group Co., Ltd. romanized
2026/09/29Generic · Class 3 多种微量元素注射液(IV) · No verified English nameCYHS2602425 Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized
2026/09/29Generic · Class 3 Simethicone Chewable TabletsCYHS2602422 Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized
2026/09/29New drug · Class 3.4 替瑞奇珠单抗注射液 · No verified English nameCXSS2600157 Cheng Hua Pharma (Hainan) Co., Ltd. romanized; Xia Er Ba Bio Technology (Hangzhou) Co., Ltd. romanized
2026/09/29New drug · Class 1 HL99自体T细胞注射液 · No verified English nameCXSL2601076 Henan Sheng Hua Long Bio Technology Co., Ltd. romanized
2026/09/29New drug · Class 1 SIM0725注射液 · No verified English nameCXSL2601075 Jiangsu Xian Sheng Pharma Co., Ltd. romanized; Xian Sheng Pharma Co., Ltd. romanized
2026/09/29New drug · Class 1 注射用SIM0505 · No verified English nameCXSL2601074 Shanghai Xian Sheng Zai Ming Pharmaceuticals Bio Technology Co., Ltd. romanized
2026/09/29New drug · Class 1 注射用BG-T187(皮下注射) · No verified English nameCXSL2601073 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2026/09/29New drug · Class 1 注射用YL413 · No verified English nameCXSL2601072 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2026/09/29New drug · Class 1 注射用HCRB001 · No verified English nameCXSL2601071 Haikou Tie Shu Da Fang Bio Technology Co., Ltd. romanized
2026/09/29New drug · Class 1 MK-8748眼内注射溶液 · No verified English nameCXSL2601070 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized

62 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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