YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 368 drug applications between 3 April 2026 and 9 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 41 drug names.
2026/04/03 – 2026/04/09
- New acceptances this week
- 368
- Drugs with new generic filings (by drug name, de-duplicated)
- 41
- 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
368filings, 56 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 233 |
| Generic | 56 |
| New drug | 46 |
| Import | 22 |
| Unspecified | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 170 |
| TCM | 146 |
| Therapeutic biologic | 46 |
| Biologic | 3 |
| 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
41 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 | Tadalafil Tablets | 3 | 1 | 23 |
| 3 | Topiramate Extended-release Capsules | 3 | 1 | 0 |
| 4 | Carboplatin Injection | 2 | 1 | 10 |
| 5 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | Erythromycin Lactobionate for Injection | 2 | 1 | 13 |
| 8 | Dexmethylphenidate Hydrochloride Exended-release Capsules | 2 | 1 | 2 |
| 9 | Ambroxol Hydrochloride Oral Solution | 2 | 1 | 46 |
| 10 | Memantine Hydrochloride Sustained-release Capsules | 2 | 1 | 2 |
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
205 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 15 | 7 | 0 |
| 2 | Hebei Wan Sui Pharma Co., Ltd. romanized | 13 | 12 | 0 |
| 3 | Hubei Tai Zi Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 4 | Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized | 9 | 8 | 0 |
| 5 | Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized | 8 | 8 | 0 |
| 6 | Merck Sharp & Dohme B.V. | 6 | 1 | 0 |
| 7 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 9 | Shandong Feng Huang Pharmaceutical Co., Ltd. romanized | 4 | 3 | 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
83 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2026/04/09Import · Class 1 | PF-07799933片 · No verified English nameJXHL2600103 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2026/04/09Import · Class 2.4 | 盐酸阿曲生坦片 · No verified English nameJXHL2600102 | Novartis Pharma AG |
| 2026/04/09Import · Class 1 | PF-07799933片 · No verified English nameJXHL2600101 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2026/04/09Generic · Class 3 | 厄贝沙坦氨氯地平片(III) · No verified English nameCYHS2600814 | Zhejiang AngLiKang Pharmaceutical CO.,LTD. |
| 2026/04/09Generic · Class 3 | 厄贝沙坦氨氯地平片(I) · No verified English nameCYHS2600813 | Zhejiang AngLiKang Pharmaceutical CO.,LTD. |
| 2026/04/09Generic · Class 3 | 低钙腹膜透析液(乳酸盐-G2.55%) · No verified English nameCYHS2600812 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2026/04/09Generic · Class 3 | Memantine Hydrochloride Sustained-release CapsulesCYHS2600809 | Li Pin Pharma (Xiamen) Co., Ltd. romanized |
| 2026/04/09Generic · Class 3 | Memantine Hydrochloride Sustained-release CapsulesCYHS2600808 | Li Pin Pharma (Xiamen) Co., Ltd. romanized |
| 2026/04/09Generic · Class 3 | Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHS2600806 | Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized |
| 2026/04/09Generic · Class 3 | Fluocinolone Acetonide,Hydroquinone And Tretinoin CreamCYHL2600042 | Hangzhou Bei Te Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/09Generic · Class 3 | Topiramate Extended-release CapsulesCYHL2600041 | Kun Yao Group Co., Ltd. romanized |
| 2026/04/09Generic · Class 3 | Topiramate Extended-release CapsulesCYHL2600040 | Kun Yao Group Co., Ltd. romanized |
| 2026/04/09Generic · Class 3 | Topiramate Extended-release CapsulesCYHL2600039 | Kun Yao Group Co., Ltd. romanized |
| 2026/04/09New drug · Class 3.1 | 半夏泻心颗粒 · No verified English nameCXZS2600019 | Changsha Xin Lin Pharmaceutical Co., Ltd. romanized |
| 2026/04/09New drug · Class 1 | 注射用帕康曲妥珠单抗 · No verified English nameCXSS2600063 | Ying En Bio Technology (Shanghai) Co., Ltd. romanized; Name not romanized |
| 2026/04/09New drug · Class 1 | SHR-3079注射液 · No verified English nameCXSL2600387 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/09New drug · Class 1 | SHR-3079注射液 · No verified English nameCXSL2600386 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/09New drug · Class 1 | FB1003重组人源化单克隆抗体注射液 · No verified English nameCXSL2600385 | Fu Bei Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/04/09New drug · Class 1 | FB1003重组人源化单克隆抗体注射液 · No verified English nameCXSL2600384 | Fu Bei Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/04/09New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHS2600053 | Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized |
| 2026/04/09New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHS2600052 | Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized |
| 2026/04/09New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHS2600051 | Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized |
53 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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