YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 429 drug applications between 5 May 2026 and 11 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 39 drug names.

2026/05/05 – 2026/05/11

Period
2026/05/05 to 2026/05/11, 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
429
Drugs with new generic filings (by drug name, de-duplicated)
39
Accepted this week, now under review
94

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

429filings, 50 of them generic

By application type

Application typeFilings
Supplement249
New drug70
Generic50
Import39
Unspecified14
Import re-registration7

By drug type

Drug typeFilings
Chemical drug196
TCM155
Therapeutic biologic66
Biologic9
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

39 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

250 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB2130
2Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized1280
3Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized1090
4Qilu Pharmaceutical Co., Ltd.941
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
6Bao Guang Pharma (Chengdu) Co., Ltd. romanized550
7Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized550
8Pfizer Inc.540
9Jilin Sheng Zhong Yan Pharma Co., Ltd. romanized540
10Shandong Xian He Pharma Co., Ltd. romanized540

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

116 this week

AcceptedDrugApplicants
2026/05/11Generic · Class 3 Lidocaine and Tetracaine CreamCYHL2600060 Beijing Hua Su Pharmaceutical Co., Ltd. romanized
2026/05/11Generic · Class 3 Lidocaine and Tetracaine CreamCYHL2600059 Beijing Hua Su Pharmaceutical Co., Ltd. romanized
2026/05/11New drug · Class 3.4 人纤维蛋白原 · No verified English nameCXSS2600082 Guangdong Dan Xia Biopharmaceutical Co., Ltd. romanized
2026/05/11New drug · Class 2.2 纳基奥仑赛注射液 · No verified English nameCXSS2600081 He Yuan Bio Technology Co., Ltd. romanized
2026/05/11New drug · Class 1 KBD102430片 · No verified English nameCXHL2600560 Kang Bai Da (Sichuan) Biopharmaceuticals Technology Co., Ltd. romanized
2026/05/11New drug · Class 1 KBD102430片 · No verified English nameCXHL2600559 Kang Bai Da (Sichuan) Biopharmaceuticals Technology Co., Ltd. romanized
2026/05/11New drug · Class 1 比瑞替尼片 · No verified English nameCXHL2600558 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2026/05/11New drug · Class 1 GW5282片 · No verified English nameCXHL2600555 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Ge Wu Bio Technology (Jiangsu) Co., Ltd. romanized
2026/05/11New drug · Class 1 GW5282片 · No verified English nameCXHL2600553 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Ge Wu Bio Technology (Jiangsu) Co., Ltd. romanized
2026/05/11New drug · Class 1 GFH276片 · No verified English nameCXHL2600552 Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/05/11New drug · Class 2.4 索托克拉片 · No verified English nameCXHL2600551 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/05/11New drug · Class 2.4 索托克拉片 · No verified English nameCXHL2600550 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/05/11New drug · Class 2.4 索托克拉片 · No verified English nameCXHL2600549 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/05/11New drug · Class 2.4 索托克拉片 · No verified English nameCXHL2600548 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/05/10Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHL2600057 Anhui Jia He Pharma Co., Ltd. romanized
2026/05/10New drug · Class 1.1 通降颗粒 · No verified English nameCXZS2600025 Jian Min Pharma Group Co., Ltd. romanized
2026/05/10New drug · Class 1 Cizutamig注射液 · No verified English nameCXSL2600489 Shanghai Tan Di Biopharmaceuticals Technology Co., Ltd. romanized
2026/05/10New drug · Class 1 IG4001肠溶片 · No verified English nameCXHL2600547 Suzhou Dian Shi Zhi Yao Pharmaceuticals Technology Co., Ltd. romanized
2026/05/09Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSS2600041 MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2026/05/09Import · Class 2.2 德莫奇单抗注射液 · No verified English nameJXSL2600114 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2026/05/09Import · Class 2.2 德莫奇单抗注射液 · No verified English nameJXSL2600113 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2026/05/09Import · Class 2.2 注射用替奈普酶 · No verified English nameJXSL2600112 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/05/09Import · Class 1 AZD2265 · No verified English nameJXHL2600162 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/09Import · Class 1 AZD9574 · No verified English nameJXHL2600161 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/09Import · Class 1 AZD9574 · No verified English nameJXHL2600160 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/09Import · Class 1 AZD9574 · No verified English nameJXHL2600159 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/09Import · Class 1 AZD9574 · No verified English nameJXHL2600158 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/09Generic · Class 3 Acetylcysteine InjectionCYHS2601066 Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized
2026/05/09Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2601064 Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanized
2026/05/09Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2601058 Anhui Huan Qiu Pharma Co., Ltd. romanized

86 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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