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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 404 drug applications between 11 April 2026 and 17 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 49 drug names.

2026/04/11 – 2026/04/17

Period
2026/04/11 to 2026/04/17, 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
404
Drugs with new generic filings (by drug name, de-duplicated)
49
Accepted this week, now under review
101

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

404filings, 67 of them generic

By application type

Application typeFilings
Supplement218
New drug68
Generic67
Import28
Unspecified12
Import re-registration11

By drug type

Drug typeFilings
Chemical drug196
TCM128
Therapeutic biologic70
Biologic9
Prophylactic biologic1

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

49 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
4Edaravone and Dexborneol Concentrated Solution for Injection2234
5注射用磷酸左奥硝唑酯二钠 · No verified English name2222
6Levetiracetam in Sodium Chloride Injection212
7Imipenem and Cilastatin Sodium for Injection216
8Loxoprofen Sodium Patches2130
9Urapidil Hydrochloride Injection216
10Milnacipran Hydrochloride Tablets218

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

254 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized740
2Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized660
3Novo Nordisk A/S610
4Guangxi Yu Lin Pharmaceutical Group Co., Ltd. romanized550
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
6Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized510
7Hunan Jiudian Pharmaceutical Co., Ltd440
8Hunan Guo Hua Pharmaceutical Co., Ltd. romanized440
9Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized440
10Xian Bo Ai Pharmaceutical 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

125 this week

AcceptedDrugApplicants
2026/04/17Import · Class 2.2 特立妥单抗注射液 · No verified English nameJXSS2600039 Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.
2026/04/17Import · Class 2.2 特立妥单抗注射液 · No verified English nameJXSS2600038 Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.
2026/04/17Import · Class 2.4 那米司特片 · No verified English nameJXHL2600116 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/04/17Import · Class 2.4 那米司特片 · No verified English nameJXHL2600115 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/04/17Generic · Class 3 Ketotifen Fumarate Oral SolutionCYHS2600887 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2026/04/17Generic · Class 3 Bepotastine Besilate Orally Disintegrating TabletsCYHS2600885 Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized
2026/04/17Generic · Class 3 Perospirone Hydrochloride TabletsCYHS2600884 Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized
2026/04/17Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2600882 Shenzhen Shi Rui Hua Pharmaceutical Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2026/04/17Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2600881 Shenzhen Shi Rui Hua Pharmaceutical Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2026/04/17New drug · Class 2.2 注射用瑞康曲妥珠单抗 · No verified English nameCXSL2600426 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/04/17New drug · Class 1 SHR-4610注射液 · No verified English nameCXSL2600425 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/04/17New drug · Class 3.2 ACYW135群脑膜炎球菌多糖结合疫苗 · No verified English nameCXSL2600424 Zhongguo Yi Xue Ke College Yi Xue Bio Xue Research Institute romanized
2026/04/17New drug · Class 2.2 伊匹木单抗N01注射液 · No verified English nameCXSL2600423 Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2026/04/17New drug · Class 1 注射用SHR-A2009 · No verified English nameCXSL2600422 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/04/17New drug · Class 1 BTL-203注射液 · No verified English nameCXSL2600421 Ben Dao Bio Technology (Hangzhou) Co., Ltd. romanized
2026/04/17New drug · Class 1 DN002注射用冻干粉针剂 · No verified English nameCXSL2600420 Suzhou Di Xin Chen Ke Bio Technology Co., Ltd. romanized
2026/04/17New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2600419 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/04/17New drug · Class 1 注射用SHR-1826 · No verified English nameCXSL2600418 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/04/17New drug · Class 1 注射用FH-006 · No verified English nameCXSL2600417 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Biopharmaceuticals Co., Ltd. romanized
2026/04/17New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSL2600416 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/04/17New drug · Class 2.4 BJ044注射液 · No verified English nameCXSL2600415 Shanghai Bao Ji Pharma Co., Ltd. romanized
2026/04/17New drug · Class 1 注射用HDM2017 · No verified English nameCXSL2600414 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2026/04/17New drug · Class 1 QY-iHEP02注射液 · No verified English nameCXSL2600413 Beijing Tian You Qi Yuan Bio Technology Co., Ltd. romanized
2026/04/17New drug · Class 1 注射用CAN016 · No verified English nameCXSL2600412 Kang Wei (Guangzhou) Bio Technology Co., Ltd. romanized
2026/04/17New drug · Class 1 HS-10502片 · No verified English nameCXHL2600459 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/17New drug · Class 1 HS-10502片 · No verified English nameCXHL2600458 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/17New drug · Class 2.4 注射用HRS5580 · No verified English nameCXHL2600457 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/04/17New drug · Class 2.4 HY21006胶囊 · No verified English nameCXHL2600455 Changchun Hai Yue Pharma Co., Ltd. romanized
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.

95 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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