YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 228 drug applications between 3 November 2021 and 9 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 38 drug names.
2021/11/03 – 2021/11/09
- New acceptances this week
- 228
- Drugs with new generic filings (by drug name, de-duplicated)
- 38
- Accepted this week, now under review
- 0
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
228filings, 44 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 123 |
| Generic | 44 |
| New drug | 26 |
| Import | 24 |
| Import re-registration | 6 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 164 |
| Therapeutic biologic | 41 |
| TCM | 19 |
| Prophylactic biologic | 4 |
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 | 氧（液态） · No verified English name | 2 | 2 | 13 |
| 2 | Amlodipine Besylate and Atorvastatin Calcium Tablets | 2 | 1 | 2 |
| 3 | Remifentanil Hydrochloride for Injection | 2 | 1 | 2 |
| 4 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 5 | 阿普米司特片 · No verified English name | 2 | 1 | 3 |
| 6 | Ranolazine Prolonged-Release Tablets | 2 | 1 | 3 |
| 7 | ω-3 鱼油中长链脂肪乳/氨基酸（16）/葡萄糖（30%）注射液 · No verified English name | 1 | 1 | 0 |
| 8 | Sodium Valproate Oral Solution | 1 | 1 | 1 |
| 9 | 丙酸氟替卡松吸入粉雾剂 · No verified English name | 1 | 1 | 1 |
| 10 | Carbetocin Injection | 1 | 1 | 6 |
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
142 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized | 7 | 1 | 0 |
| 2 | Guangdong Ke Lun Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 3 | Hunan De Kang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | UCB Pharma SA | 5 | 2 | 0 |
| 5 | Liu He Zhang Long Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Zhejiang Zan Sheng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Novartis Europharm Limited | 4 | 2 | 0 |
| 8 | Eli Lilly Nederland B.V. | 4 | 1 | 0 |
| 9 | Hangzhou Minsheng Pharmaceutical Co., Ltd | 3 | 2 | 0 |
| 10 | Jiangxi Qing Feng Pharma Co., Ltd. romanized | 3 | 2 | 3 |
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
55 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/11/09Import · Class 1 | DS-1062a · No verified English nameJXSL2101124 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2021/11/09Import · Class 2.4 | 盐酸替洛利生薄膜衣片 · No verified English nameJXHL2101239 | BIOPROJET PHARMA; Citrine(Shanghai) Co.Ltd |
| 2021/11/09Import · Class 2.4 | 盐酸替洛利生薄膜衣片 · No verified English nameJXHL2101238 | BIOPROJET PHARMA; Citrine(Shanghai) Co.Ltd |
| 2021/11/09Import · Class 1 | BI 690517片 · No verified English nameJXHL2101237 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/11/09Import · Class 1 | BI 690517片 · No verified English nameJXHL2101236 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/11/09Generic · Class 3 | Colesevelam Hydrochloride TabletsCYHS2101982 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. |
| 2021/11/09Generic · Class 3 | Amisulpride InjectionCYHL2101038 | Beijing Pu De Kang Li Pharmaceuticals Technology Development Co., Ltd. romanized |
| 2021/11/09New drug · Class 3.4 | 破伤风人免疫球蛋白 · No verified English nameCXSS2101044 | Xinjiang De Yuan Bio Gong Cheng Co., Ltd. romanized |
| 2021/11/09New drug · Class 3.4 | 破伤风人免疫球蛋白 · No verified English nameCXSS2101043 | Xinjiang De Yuan Bio Gong Cheng Co., Ltd. romanized |
| 2021/11/09New drug · Class 3.3 | CMAB807X注射液 · No verified English nameCXSL2101413 | Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized |
| 2021/11/09New drug · Class 1 | CM350 · No verified English nameCXSL2101412 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2021/11/09New drug · Class 2.2 | PDX-02 · No verified English nameCXHL2101638 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2021/11/09New drug · Class 2.4 | Chidamide TabletsCXHL2101637 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized |
| 2021/11/09New drug · Class 2.2 | 富马酸伏诺拉生注射液 · No verified English nameCXHL2101636 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2021/11/09New drug · Class 1 | FZJ-003胶囊 · No verified English nameCXHL2101633 | Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/09New drug · Class 1 | FZJ-003胶囊 · No verified English nameCXHL2101632 | Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/08Import · Class 1 | PH94B 鼻用喷雾剂 · No verified English nameJXHL2101235 | VistaGen Therapeutics Inc. |
| 2021/11/08Generic · Class 3 | Ranolazine Prolonged-Release TabletsCYHS2101987 | Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized |
| 2021/11/08Generic · Class 3 | Ranolazine Prolonged-Release TabletsCYHS2101986 | Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized |
| 2021/11/08Generic · Class 3 | Levofloxacin InjectionCYHS2101981 | Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized |
| 2021/11/08Generic · Class 3 | Olmesartan Medoxomil Orally Disintegrating TabletsCYHS2101960 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2021/11/08Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2101952 | Hangzhou Shang He Health Technology Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized |
| 2021/11/08Generic · Class 3 | 酒石酸阿福特罗吸入溶液 · No verified English nameCYHL2101037 | Jiangsu Zhang Tai Pharma Co., Ltd. romanized |
| 2021/11/08Generic · Class 3 | Olanzapine Pamoate powder and solvent for prolonged-release suspension for injectionCYHL2101036 | Zhejiang Sheng Zhao Drug Technology Co., Ltd. romanized |
| 2021/11/08New drug · Class 3.3 | 托珠单抗注射液 · No verified English nameCXSS2101049 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2021/11/08New drug · Class 3.3 | 托珠单抗注射液 · No verified English nameCXSS2101048 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2021/11/08New drug · Class 3.3 | 托珠单抗注射液 · No verified English nameCXSS2101047 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2021/11/08New drug · Class 1 | QX005N注射液 · No verified English nameCXSL2101411 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/08New drug · Class 1 | YH004注射液 · No verified English nameCXSL2101410 | Name not romanized |
| 2021/11/08New drug · Class 1 | BR105注射液 · No verified English nameCXSL2101409 | Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized; Hai Zheng Biopharmaceutical Co., Ltd. romanized |
25 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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