YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 367 drug applications between 28 January 2026 and 3 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 48 drug names.

2026/01/28 – 2026/02/03

Period
2026/01/28 to 2026/02/03, 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
367
Drugs with new generic filings (by drug name, de-duplicated)
48
Accepted this week, now under review
99

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

367filings, 63 of them generic

By application type

Application typeFilings
Supplement216
Generic63
New drug57
Import15
Unspecified8
Import re-registration8

By drug type

Drug typeFilings
Chemical drug192
TCM109
Therapeutic biologic59
Prophylactic biologic4
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

48 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cefmetazole Sodium for Injection317
2莫立司他钠片 · No verified English name310
3褪黑素颗粒 · No verified English name2212
4Diclofenac Diethylamine Emulgel2120
5左羟丙哌嗪口服溶液 · No verified English name218
6Empagliflozin Tablets2118
7Galantamine Hydrobromide Tablets212
8注射用头孢他啶/氯化钠注射液 · No verified English name213
9Doxycycline Hyclate for Injection2111
10盐酸特比萘芬喷雾剂 · No verified English name217

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

211 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ha Yao Group Bio Gong Cheng Co., Ltd. romanized1680
2Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized14140
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
4Shen Wei Pharma Group Co., Ltd. romanized660
5Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized660
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized640
7Bayer AG620
8Novo Nordisk A/S610
9Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized550
10Da Jia Wei Kang Biopharmaceutical 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

95 this week

AcceptedDrugApplicants
2026/02/03Import · Class 1 BI 764532 输注用浓缩粉末 · No verified English nameJXSL2600037 Boehringer lngelheim International GmbH; Boehringer lngelheim (China) Investment Co. Ltd.
2026/02/03Generic · Class 3 Ketorolac Trometamol TabletsCYHS2600346 Hunan Jiudian Pharmaceutical Co., Ltd
2026/02/03Generic · Class 3 Torsemide InjectionCYHS2600341 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2026/02/03Generic · Class 3 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2600340 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/02/03Generic · Class 3 复方匹可硫酸钠颗粒 · No verified English nameCYHS2600339 Zhejiang Hao Ge Pharma Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2026/02/03New drug · Class 1 注射用GenSci136 · No verified English nameCXSL2600163 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/02/03New drug · Class 1 注射用SHR-9839(sc) · No verified English nameCXSL2600162 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/02/03New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2600161 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/02/03New drug · Class 1 注射用SHR-1826 · No verified English nameCXSL2600160 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/02/03New drug · Class 1 SAL0896注射液 · No verified English nameCXSL2600159 Nanjing Sai Le Si Biopharmaceutical Co., Ltd. romanized
2026/02/03New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2600158 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/02/03New drug · Class 1 注射用FH-006 · No verified English nameCXSL2600157 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Biopharmaceuticals Co., Ltd. romanized
2026/02/03New drug · Class 1 注射用HY016 · No verified English nameCXHL2600141 Tianjin Bo Tai Pharmaceuticals Technology Co., Ltd. romanized
2026/02/03New drug · Class 2.2 葡萄糖迟释片 · No verified English nameCXHL2600140 Zhejiang Han Mai Pharmaceuticals Technology Co., Ltd. romanized
2026/02/03New drug · Class 1 HRS-6093片 · No verified English nameCXHL2600139 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/02/03New drug · Class 1 HRS-6093片 · No verified English nameCXHL2600138 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/02/02New drug · Class 1 HX102片 · No verified English nameCXHL2600137 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2026/02/02New drug · Class 1 HX102片 · No verified English nameCXHL2600136 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2026/01/31Import · Class 1 PF-08634404 · No verified English nameJXSL2600036 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/01/31Import · Class 1 PF-08046047 · No verified English nameJXSL2600035 Pfizer Inc.; Pfizer Investment CO. Ltd.
2026/01/31Import · Class 1 PF-08046054 (注射用冻干粉针) · No verified English nameJXSL2600034 Pfizer Inc.; Pfizer Investment CO. Ltd.
2026/01/31Import · Class 1 BMS-986504片 · No verified English nameJXHL2600031 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/01/31Generic · Class 3 Galantamine Hydrobromide TabletsCYHS2600329 Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized; Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized
2026/01/31Generic · Class 3 Galantamine Hydrobromide TabletsCYHS2600328 Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized; Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized
2026/01/31Generic · Class 3 Etoposide InjectionCYHS2600327 Wuxi Zi Shan Pharma Co., Ltd. romanized; Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2026/01/31Generic · Class 3 Doxycycline Hyclate for InjectionCYHS2600321 Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized
2026/01/31Generic · Class 3 Carbocisteine Oral SolutionCYHS2600320 Chengdu Giantech Hi-technology Development Co., Ltd.; Hunan Jiudian Pharmaceutical Co., Ltd
2026/01/31Generic · Class 3 Doxycycline Hyclate for InjectionCYHS2600319 Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized
2026/01/31Generic · Class 3 莫立司他钠片 · No verified English nameCYHL2600019 Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized
2026/01/31Generic · Class 3 莫立司他钠片 · No verified English nameCYHL2600018 Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized

65 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.