YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 349 drug applications between 9 September 2026 and 15 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 38 drug names.
2026/09/09 – 2026/09/15
- New acceptances this week
- 349
- Drugs with new generic filings (by drug name, de-duplicated)
- 38
- Accepted this week, now under review
- 302
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
349filings, 49 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 200 |
| New drug | 77 |
| Generic | 49 |
| Import | 15 |
| Unspecified | 4 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 161 |
| TCM | 114 |
| Therapeutic biologic | 67 |
| Prophylactic biologic | 5 |
| Biologic | 2 |
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
38 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸金刚烷胺口服溶液 · No verified English name | 3 | 1 | 3 |
| 2 | Polidocanol Injection | 3 | 1 | 23 |
| 3 | Indacaterol Maleate and Glycopyrronium Bromide Powder for Inhalation | 2 | 2 | 3 |
| 4 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 5 | Nilotinib Capsules | 2 | 1 | 6 |
| 6 | Ambroxol Hydrochloride Oral Solution | 2 | 1 | 46 |
| 7 | Ziprasidone Hydrochloride Capsules | 2 | 1 | 9 |
| 8 | Oseltamivir Phosphate Capsules | 2 | 1 | 39 |
| 9 | Sulindac Tablets | 2 | 1 | 5 |
| 10 | Acetylcysteine Oral Solution | 1 | 1 | 11 |
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
222 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Bo Hui Biopharmaceutical (Yunnan) Co., Ltd. romanized | 6 | 5 | 0 |
| 3 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 6 | 3 | 0 |
| 4 | F. Hoffmann-La Roche Ltd | 6 | 1 | 0 |
| 5 | Shenzhen Han Yu Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | Shanxi Tian Sheng Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Jiangxi Hua Tai Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Shaanxi Ou Ke Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Tong Hua Bai Xin Pharma Co., Ltd. romanized | 4 | 4 | 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
106 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/15Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600408 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/09/15Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600407 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/09/15Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600406 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/09/15Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600405 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/09/15Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600404 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/09/15Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600403 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/09/15Import · Class 1 | RZL-012注射液 · No verified English nameJXHL2600402 | Raziel Therapeutics (RT) Ltd.; Tianjin Juvestar Biotech Co. Ltd. |
| 2026/09/15Generic · Class 3 | 盐酸金刚烷胺口服溶液 · No verified English nameCYHS2602291 | Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2026/09/15Generic · Class 3 | 盐酸金刚烷胺口服溶液 · No verified English nameCYHS2602290 | Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2026/09/15Generic · Class 3 | 盐酸金刚烷胺口服溶液 · No verified English nameCYHS2602289 | Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2026/09/15Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2602288 | Zhuhai Jian Fu Pharmaceutical Co., Ltd. romanized |
| 2026/09/15Generic · Class 3 | Folic Acid TabletsCYHS2602286 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2026/09/15Generic · Class 3 | Sulindac TabletsCYHS2602279 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2026/09/15Generic · Class 3 | Sulindac TabletsCYHS2602278 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2026/09/15Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2602277 | Zhejiang Qian Jin Pharma Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized |
| 2026/09/15Generic · Class 3 | 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2602274 | Yuan Da Pharmaceuticals (Xian) Co., Ltd. romanized; Beijing Hua Jin Pharmaceutical Co., Ltd. romanized |
| 2026/09/15New drug · Class 1 | 3SC002注射液(皮下注射) · No verified English nameCXSL2601007 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/09/15New drug · Class 1 | 3SC002注射液 · No verified English nameCXSL2601006 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/09/15New drug · Class 1 | KT502注射液 · No verified English nameCXSL2601004 | Kai Lin Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/09/15New drug · Class 1 | IBI3009 · No verified English nameCXSL2601000 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/09/15New drug · Class 1 | IBI3014 · No verified English nameCXSL2600998 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/09/15New drug · Class 1 | 注射用JS203 · No verified English nameCXSL2600997 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/15New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2600996 | Hua Sai Ling Hang (Beijing) Bio Technology Co., Ltd. romanized |
| 2026/09/15New drug · Class 1 | 注射用美罗培南普纳巴坦 · No verified English nameCXHS2600134 | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized |
| 2026/09/15New drug · Class 1 | 注射用美罗培南普纳巴坦 · No verified English nameCXHS2600133 | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized |
| 2026/09/15New drug · Class 2.2 | BCM347 · No verified English nameCXHS2600132 | Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized |
| 2026/09/15New drug · Class 2.2 | 维生素K1注射用乳剂 · No verified English nameCXHS2600131 | Xian An Jian Pharma Co., Ltd. romanized |
| 2026/09/15New drug · Class 1 | 马来酸依格美妥司他片 · No verified English nameCXHS2600130 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized |
| 2026/09/15New drug · Class 2.2 | MEI-011泡沫剂 · No verified English nameCXHL2601130 | Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/15New drug · Class 2.2 | MEI-011泡沫剂 · No verified English nameCXHL2601129 | Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
76 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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