YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 526 drug applications between 7 October 2026 and 13 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 91, covering 60 drug names.

2026/10/07 – 2026/10/13

Period
2026/10/07 to 2026/10/13, 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
526
Drugs with new generic filings (by drug name, de-duplicated)
60
Accepted this week, now under review
469

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

526filings, 91 of them generic

By application type

Application typeFilings
Supplement275
New drug101
Generic91
Import32
Import re-registration18
Unspecified9

By drug type

Drug typeFilings
Chemical drug278
TCM147
Therapeutic biologic99
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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dotinurad Tablets4255
2Sacubitril Valsartan Sodium Tablets4270
3Allopurinol Tablets324
4Brivaracetam Tablets3219
5Ixazomib Citrate Capsules317
6Dihydrocodeine Tartrate Sustained Realese Tablets313
7二硫化硒洗剂 · No verified English name2214
8Glucosamine Sulfate Capsules2251
9Mupirocin Ointment2230
10Emedastine Difumarate Sustained-release Capsules2111

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

295 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Dong E E Jiao Co., Ltd. romanized11110
2Pfizer Inc.920
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
8Upjohn Manufacturing Ireland Unlimited Company610
9Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized610
10Mian Yang Yi Kang Pharmaceutical Co., Ltd. romanized550

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

172 this week

AcceptedDrugApplicants
2026/10/13Import · Class 3.1 尼塔奇单抗注射液(皮下注射) · No verified English nameJXSS2600094 Joint Stock Company “BIOCAD”(JSC “BIOCAD”); Gen8 (SH) Limited
2026/10/13Import · Class 2.2 瑞利珠单抗注射液 · No verified English nameJXSS2600093 Alexion Europe SAS; Alexion Pharma International Operations Limited; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/13Import · Class 2.2 瑞利珠单抗注射液 · No verified English nameJXSS2600092 Alexion Europe SAS; Alexion Pharma International Operations Limited; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/13Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2600448 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/10/13Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2600447 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/10/13Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2600446 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/10/13Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2600445 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/10/13Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2600444 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/10/13Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2600443 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/10/13Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2600442 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/10/13Import · Class 1 GVV858 · No verified English nameJXHL2600441 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/10/13Generic · Class 3 Cetylpyridinium Chloride Buccal TabletsCYHS2602521 Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2026/10/13Generic · Class 3 Glycopyrrolate InjectionCYHS2602516 Henan Pu Rui Pharma Co., Ltd. romanized
2026/10/13Generic · Class 3 Glycopyrrolate InjectionCYHS2602515 Henan Pu Rui Pharma Co., Ltd. romanized
2026/10/13Generic · Class 3 Benzbromarone TabletsCYHS2602511 Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized
2026/10/13Generic · Class 3 中性腹膜透析液(乳酸盐-G2.5%) · No verified English nameCYHS2602509 Jiangsu Jie Rui Medical Technology Co., Ltd. romanized; Shandong Hua Mao Pharma Co., Ltd. romanized
2026/10/13Generic · Class 3 中性腹膜透析液(乳酸盐-G1.5%) · No verified English nameCYHS2602508 Jiangsu Jie Rui Medical Technology Co., Ltd. romanized; Shandong Hua Mao Pharma Co., Ltd. romanized
2026/10/13Generic · Class 3 Brivaracetam TabletsCYHS2602507 Xi Nan Pharma Co., Ltd. romanized
2026/10/13Generic · Class 3 Acetylcysteine TabletsCYHS2602506 Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized
2026/10/13New drug · Class 1 AI-081注射液 · No verified English nameCXSL2601114 Nanjing Ang Ke Mian Yi Biopharmaceuticals Co., Ltd. romanized
2026/10/13New drug · Class 1 AI-081注射液 · No verified English nameCXSL2601113 Nanjing Ang Ke Mian Yi Biopharmaceuticals Co., Ltd. romanized
2026/10/13New drug · Class 1 IMC-003 · No verified English nameCXSL2601112 Yi Ming Kai Er Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/10/13New drug · Class 1 SHR-6129注射液 · No verified English nameCXSL2601111 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/10/13New drug · Class 1 SI-B001双特异性抗体注射液 · No verified English nameCXSL2601110 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/10/13New drug · Class 2.2 注射用BL-B01D1 · No verified English nameCXSL2601109 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/10/13New drug · Class 1 SIBP-A21注射液 · No verified English nameCXSL2601108 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2026/10/13New drug · Class 1 注射用TJ101 · No verified English nameCXSL2601107 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2026/10/13New drug · Class 2.4 贝泽昔替尼片 · No verified English nameCXHS2600139 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized; Shandong Yao Shi Pharma Co., Ltd. romanized
2026/10/13New drug · Class 2.4 贝泽昔替尼片 · No verified English nameCXHS2600138 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized; Shandong Yao Shi Pharma Co., Ltd. romanized
2026/10/13New drug · Class 1 BGB-58067片 · No verified English nameCXHL2601276 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized

142 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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