YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 401 drug applications between 10 April 2026 and 16 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 50 drug names.

2026/04/10 – 2026/04/16

Period
2026/04/10 to 2026/04/16, 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
401
Drugs with new generic filings (by drug name, de-duplicated)
50
Accepted this week, now under review
103

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

401filings, 66 of them generic

By application type

Application typeFilings
Supplement228
Generic66
New drug65
Import24
Import re-registration13
Unspecified5

By drug type

Drug typeFilings
Chemical drug206
TCM125
Therapeutic biologic68
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

50 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1奥氮平萨米多芬片 · No verified English name410
2Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3223
3Ambroxol Hydrochloride Solution For Inhalation3110
4注射用磷酸左奥硝唑酯二钠 · No verified English name2222
5Bromhexine Hydrochloride Solution For Inhalation211
6Levetiracetam in Sodium Chloride Injection212
7Loxoprofen Sodium Patches2130
8Urapidil Hydrochloride Injection216
9Milnacipran Hydrochloride Tablets218
10Diphenhydramine Hydrochloride Injection219

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

239 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized830
2Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized740
3Li Lai Suzhou Pharmaceutical Co., Ltd. romanized620
4Novo Nordisk A/S610
5Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized510
6Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized440
7Guangxi Yu Lin Pharmaceutical Group Co., Ltd. romanized440
8Hunan Jiudian Pharmaceutical Co., Ltd440
9Hunan Guo Hua Pharmaceutical Co., Ltd. romanized440
10Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized440

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

119 this week

AcceptedDrugApplicants
2026/04/16Import · Class 3.1 古塞奇尤单抗注射液 · No verified English nameJXSS2600037 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.
2026/04/16Import · Class 3.1 古塞奇尤单抗注射液 · No verified English nameJXSS2600036 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.
2026/04/16Import · Class 3.1 注射用德曲妥珠单抗 · No verified English nameJXSS2600035 Daiichi Sankyo Europe GmbH; Simtra Deutschland GmbH; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2026/04/16Import · Class 1 酒石酸吉雷司群胶囊 · No verified English nameJXHS2600039 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd.
2026/04/16Generic · Class 3 蔗糖羟基氧化铁颗粒 · No verified English nameCYHS2600878 Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized
2026/04/16Generic · Class 3 Paracetamol and Ibuprofen TabletsCYHS2600876 Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2026/04/16Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2600872 Beijing Ge Lin Yi Rui Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Yu Hui Pharmaceutical Co., Ltd. romanized
2026/04/16Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2600871 Beijing Ge Lin Yi Rui Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Yu Hui Pharmaceutical Co., Ltd. romanized
2026/04/16New drug · Class 1.1 小儿辛苍通窍颗粒 · No verified English nameCXZL2600036 Jian Min Pharma Group Co., Ltd. romanized
2026/04/16New drug · Class 1 注射用SKB500 · No verified English nameCXSL2600411 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/04/16New drug · Class 1 注射用甲磺酸普依司他 · No verified English nameCXHL2600456 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/16New drug · Class 1 BGB-43395片 · No verified English nameCXHL2600454 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/04/16New drug · Class 1 BGB-43395片 · No verified English nameCXHL2600453 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/04/16New drug · Class 1 BGB-43395片 · No verified English nameCXHL2600452 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/04/16New drug · Class 1 BGB-43395片 · No verified English nameCXHL2600451 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/04/16New drug · Class 1 GW01-200片 · No verified English nameCXHL2600448 Gao Wei Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2026/04/16New drug · Class 1 GW01-200片 · No verified English nameCXHL2600447 Gao Wei Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2026/04/16New drug · Class 1 TQC5524吸入粉雾剂 · No verified English nameCXHL2600446 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2026/04/16New drug · Class 1 TQC5524吸入粉雾剂 · No verified English nameCXHL2600445 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2026/04/16New drug · Class 1 TQC5524吸入粉雾剂 · No verified English nameCXHL2600444 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2026/04/16New drug · Class 1 TQC5524吸入粉雾剂 · No verified English nameCXHL2600443 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2026/04/16New drug · Class 2.2 盐酸艾司氯胺酮口颊粘膜溶液 · No verified English nameCXHL2600442 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/04/15Import · Class 2.3 古塞奇尤单抗/戈利木单抗(JNJ-78934804)注射液 · No verified English nameJXSL2600099 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/04/15Generic · Class 3 Ferrous Succinate TabletsCYHS2600868 Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized
2026/04/15Generic · Class 3 氟[18F]妥司特注射液 · No verified English nameCYHS2600867 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized; Beijing Shan Wei Zheng Zi Pharmaceuticals Technology Co., Ltd. romanized; Guo Tong (Zhong Shan) Pharmaceuticals Technology Co., Ltd. romanized; Guo Tong (Wuxi) Pharmaceuticals Technology Co., Ltd. romanized
2026/04/15Generic · Class 3 Acetylcysteine TabletsCYHS2600860 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized
2026/04/15New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600070 Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized
2026/04/15New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600069 Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized
2026/04/15New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600068 Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized
2026/04/15New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600067 Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized

89 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.