YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 343 drug applications between 4 April 2026 and 10 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 44 drug names.

2026/04/04 – 2026/04/10

Period
2026/04/04 to 2026/04/10, 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
343
Drugs with new generic filings (by drug name, de-duplicated)
44
Accepted this week, now under review
98

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

343filings, 57 of them generic

By application type

Application typeFilings
Supplement201
Generic57
New drug50
Import21
Import re-registration8
Unspecified6

By drug type

Drug typeFilings
Chemical drug177
TCM105
Therapeutic biologic54
Biologic4
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

44 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ibuprofen Suspension3214
2Diclofenac Diethylamine Emulgel3120
3Topiramate Extended-release Capsules310
4Bromhexine Hydrochloride Solution For Inhalation211
5Vonoprazan Fumarate Tablets2160
6Erythromycin Lactobionate for Injection2113
7Dexmethylphenidate Hydrochloride Exended-release Capsules212
8Ambroxol Hydrochloride Oral Solution2146
9Memantine Hydrochloride Sustained-release Capsules212
10雌二醇片/雌二醇地屈孕酮片复合包装 · No verified English name2114

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

189 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ha Yao Group Bio Gong Cheng Co., Ltd. romanized1480
2Hebei Wan Sui Pharma Co., Ltd. romanized11100
3Merck Sharp & Dohme B.V.1020
4Hubei Tai Zi Pharma Co., Ltd. romanized660
5Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized630
6Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized610
7Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized550
8Boehringer Ingelheim International GmbH510
9Li Lai Suzhou Pharmaceutical Co., Ltd. romanized510
10Bristol-Myers Squibb Pharma EEIG420

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

89 this week

AcceptedDrugApplicants
2026/04/10Import · Class 3.1 奥妥珠单抗注射液 · No verified English nameJXSS2600034 Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH; Roche (China) Holding Ltd.
2026/04/10Import · Class 2.3 古塞奇尤单抗/戈利木单抗(JNJ-78934804)注射液 · No verified English nameJXSL2600098 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/04/10Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2600830 Henan Pu Rui Pharma Co., Ltd. romanized
2026/04/10Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2600829 Guizhou Qian Yao Group Pharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2026/04/10Generic · Class 3 Bromhexine Hydrochloride Solution For InhalationCYHL2600044 Shandong Hui Cheng Pharma Co., Ltd. romanized
2026/04/10Generic · Class 3 Bromhexine Hydrochloride Solution For InhalationCYHL2600043 Shandong Hui Cheng Pharma Co., Ltd. romanized
2026/04/10New drug · Class 1 SGT003注射液 · No verified English nameCXSL2600397 Beijing Shun Jing Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/10New drug · Class 1 YB1-X7注射液(静脉输注) · No verified English nameCXSL2600396 Shao Xing Shan Wei Te Bio Technology Co., Ltd. romanized
2026/04/10New drug · Class 2.2 依苏帕格鲁肽α注射液 · No verified English nameCXSL2600395 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized
2026/04/10New drug · Class 2.2 依苏帕格鲁肽α注射液 · No verified English nameCXSL2600394 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized
2026/04/10New drug · Class 2.2 依苏帕格鲁肽α注射液 · No verified English nameCXSL2600393 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized
2026/04/10New drug · Class 2.2 依苏帕格鲁肽α注射液 · No verified English nameCXSL2600392 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized
2026/04/10New drug · Class 1 SHR-4685注射液 · No verified English nameCXSL2600391 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/04/10New drug · Class 1 SHR-3079注射液 · No verified English nameCXSL2600390 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/04/10New drug · Class 1 SHR-3079注射液 · No verified English nameCXSL2600389 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/04/10New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2600388 Guangzhou Bai Ji Ji Yin Technology Co., Ltd. romanized
2026/04/10New drug · Class 1 LY4064809片 · No verified English nameCXHL2600429 Li Lai Suzhou Pharmaceutical Co., Ltd. romanized
2026/04/10New drug · Class 1 LY4064809片 · No verified English nameCXHL2600428 Li Lai Suzhou Pharmaceutical Co., Ltd. romanized
2026/04/10New drug · Class 1 LY4064809片 · No verified English nameCXHL2600427 Li Lai Suzhou Pharmaceutical Co., Ltd. romanized
2026/04/10New drug · Class 1 LY4064809片 · No verified English nameCXHL2600426 Li Lai Suzhou Pharmaceutical Co., Ltd. romanized
2026/04/10New drug · Class 1 LY4064809片 · No verified English nameCXHL2600425 Li Lai Suzhou Pharmaceutical Co., Ltd. romanized
2026/04/10New drug · Class 1 LXH-2103注射液 · No verified English nameCXHL2600424 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2026/04/09Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600033 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D(China)Co. Ltd
2026/04/09Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600032 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D(China)Co. Ltd
2026/04/09Import · Class 1 BI 3034701注射液 · No verified English nameJXHL2600109 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/04/09Import · Class 1 BI 3034701注射液 · No verified English nameJXHL2600108 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/04/09Import · Class 1 BI 3034701注射液 · No verified English nameJXHL2600107 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/04/09Import · Class 1 BI 3034701注射液 · No verified English nameJXHL2600106 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/04/09Import · Class 1 BI 3034701注射液 · No verified English nameJXHL2600105 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/04/09Import · Class 1 GSK6042981片 · No verified English nameJXHL2600104 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited

59 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.