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
- 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 type | Filings |
|---|---|
| Supplement | 201 |
| Generic | 57 |
| New drug | 50 |
| Import | 21 |
| Import re-registration | 8 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 177 |
| TCM | 105 |
| Therapeutic biologic | 54 |
| Biologic | 4 |
| Prophylactic biologic | 3 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ibuprofen Suspension | 3 | 2 | 14 |
| 2 | Diclofenac Diethylamine Emulgel | 3 | 1 | 20 |
| 3 | Topiramate Extended-release Capsules | 3 | 1 | 0 |
| 4 | Bromhexine Hydrochloride Solution For Inhalation | 2 | 1 | 1 |
| 5 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 6 | Erythromycin Lactobionate for Injection | 2 | 1 | 13 |
| 7 | Dexmethylphenidate Hydrochloride Exended-release Capsules | 2 | 1 | 2 |
| 8 | Ambroxol Hydrochloride Oral Solution | 2 | 1 | 46 |
| 9 | Memantine Hydrochloride Sustained-release Capsules | 2 | 1 | 2 |
| 10 | 雌二醇片/雌二醇地屈孕酮片复合包装 · No verified English name | 2 | 1 | 14 |
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) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 14 | 8 | 0 |
| 2 | Hebei Wan Sui Pharma Co., Ltd. romanized | 11 | 10 | 0 |
| 3 | Merck Sharp & Dohme B.V. | 10 | 2 | 0 |
| 4 | Hubei Tai Zi Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 9 | Li Lai Suzhou Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Bristol-Myers Squibb Pharma EEIG | 4 | 2 | 0 |
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
| Accepted | Drug | Applicants |
|---|---|---|
| 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.