YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 546 drug applications between 10 October 2026 and 16 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 65 drug names.

2026/10/10 – 2026/10/16

Period
2026/10/10 to 2026/10/16, 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
546
Drugs with new generic filings (by drug name, de-duplicated)
65
Accepted this week, now under review
481

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

546filings, 96 of them generic

By application type

Application typeFilings
Supplement268
New drug117
Generic96
Import32
Unspecified17
Import re-registration16

By drug type

Drug typeFilings
Chemical drug282
TCM143
Therapeutic biologic111
Biologic6
Prophylactic biologic4

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

65 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

326 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Pfizer Inc.920
2Eli Lilly and Company850
3N. V. Organon810
4Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized770
5Boehringer Ingelheim International GmbH710
6Guangxi Bao Rui Tan Pharmaceutical Co., Ltd. romanized640
7AbbVie Inc.620
8Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized610
9Shanxi Huang He Zhong Yao Co., Ltd. romanized550
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

189 this week

AcceptedDrugApplicants
2026/10/16Import · Class 3.4 注射用A型肉毒毒素 · No verified English nameJXSL2600272 NUMECO Inc.; Ningbo Medicore Technology Co. Ltd.
2026/10/16Import · Class 1 Retatrutide注射液 · No verified English nameJXHL2600453 Eli Lilly and Company; Lilly Suzhou PharmaceuLical Co. LLd.
2026/10/16Import · Class 1 Retatrutide注射液 · No verified English nameJXHL2600452 Eli Lilly and Company; Lilly Suzhou PharmaceuLical Co. LLd.
2026/10/16Import · Class 1 Retatrutide注射液 · No verified English nameJXHL2600451 Eli Lilly and Company; Lilly Suzhou PharmaceuLical Co. LLd.
2026/10/16Import · Class 1 Retatrutide注射液 · No verified English nameJXHL2600450 Eli Lilly and Company; Lilly Suzhou PharmaceuLical Co. LLd.
2026/10/16Generic · Class 3 盐酸利多卡因胶浆 · No verified English nameCYHS2602553 Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2026/10/16Generic · Class 3 Propranolol hydrochloride oral solutionCYHS2602552 Shenyang Tian Bang Pharma Co., Ltd. romanized
2026/10/16Generic · Class 3 Colistimethate Sodium for InjectionCYHS2602551 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Yangtze River Pharmaceutical Group Co., Ltd
2026/10/16New drug · Class 3.1 易黄汤颗粒 · No verified English nameCXZS2600056 Guiyang Xin Tian Pharma Co., Ltd. romanized
2026/10/16New drug · Class 2.3 金花清感颗粒 · No verified English nameCXZS2600055 Ju Xie Chang (Beijing) Pharma Co., Ltd. romanized
2026/10/16New drug · Class 1 注射用JNJ-98768111 · No verified English nameCXSL2601138 Qiang Sheng (Zhongguo) Investment Co., Ltd. romanized
2026/10/16New drug · Class 1 SCTB41注射液 · No verified English nameCXSL2601137 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/10/16New drug · Class 1 SCTC21C注射液 · No verified English nameCXSL2601136 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/10/16New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2601135 Name not romanized
2026/10/16New drug · Class 1 LW402片 · No verified English nameCXHL2601298 Shanghai Zhang Sen Pharma Co., Ltd. romanized
2026/10/16New drug · Class 1 LW402片 · No verified English nameCXHL2601297 Shanghai Zhang Sen Pharma Co., Ltd. romanized
2026/10/16New drug · Class 1 VC005片 · No verified English nameCXHL2601296 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2026/10/16New drug · Class 2.2; 2.4 烟酰胺腺嘌呤二核苷酸片 · No verified English nameCXHL2601295 Kang Nuo Biopharmaceutical Co., Ltd. romanized
2026/10/16New drug · Class 2.1; 2.3 LX2423片 · No verified English nameCXHL2601294 Shanghai Li Xin Lian Chuang Biopharmaceuticals Technology Co., Ltd. romanized
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

159 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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