YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 210 drug applications between 29 July 2021 and 4 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 31, covering 24 drug names.
2021/07/29 – 2021/08/04
- New acceptances this week
- 210
- Drugs with new generic filings (by drug name, de-duplicated)
- 24
- Accepted this week, now under review
- 1
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
210filings, 31 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 97 |
| New drug | 50 |
| Generic | 31 |
| Import | 16 |
| Unspecified | 9 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 144 |
| Therapeutic biologic | 33 |
| TCM | 31 |
| In vitro diagnostic reagent | 1 |
| Prophylactic biologic | 1 |
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
24 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Carbamazepine Extended-release Tablets | 3 | 1 | 0 |
| 2 | Alanyl Glutamine Injection | 2 | 1 | 4 |
| 3 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 4 | Caspofungin Acetate for Injection | 2 | 1 | 8 |
| 5 | Trimetazidine Dihydrochloride Tablets | 2 | 1 | 0 |
| 6 | Oseltamivir Phosphate Capsules | 2 | 1 | 39 |
| 7 | Ezetimibe Tablets | 1 | 1 | 4 |
| 8 | Lidocaine and Prilocaine Cream | 1 | 1 | 24 |
| 9 | Bromhexine Hydrochloride Solution For Inhalation | 1 | 1 | 1 |
| 10 | 富马酸替诺福韦二吡呋酯颗粒 · No verified English name | 1 | 1 | 0 |
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
126 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Fu Ren Heng Feng Pharma Co., Ltd. romanized | 11 | 11 | 0 |
| 2 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 9 | 4 | 0 |
| 3 | Shaanxi An Yuan Tang Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized | 6 | 3 | 0 |
| 5 | Eli Lilly and Company | 6 | 1 | 0 |
| 6 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 2 | 0 |
| 7 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 3 | 2 | 0 |
| 8 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 3 | 2 | 0 |
| 9 | Bristol-Myers Squibb Pharma EEIG | 3 | 1 | 0 |
| 10 | Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 3 | 1 | 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
72 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/08/03Import · Class 2.2 | DS-8201a · No verified English nameJXSL2101086 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2021/08/03Import · Class 1 | BI 905711输注用粉末 · No verified English nameJXSL2101085 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/08/03Import · Class 1 | NIS793 · No verified English nameJXSL2101079 | Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd |
| 2021/08/03Import · Class 1 | AR882胶囊 · No verified English nameJXHL2101149 | Arthrosi Therapeutics INC; Hangzhou Tigermed Consulting Co. Ltd. |
| 2021/08/03Import · Class 1 | Elinzanetant 软胶囊 · No verified English nameJXHL2101148 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2021/08/03Generic · Class 3 | Bromhexine Hydrochloride Solution For InhalationCYHS2101521 | Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2021/08/03Generic · Class 3 | Carbamazepine Extended-release TabletsCYHS2101519 | Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2021/08/03Generic · Class 3 | Carbamazepine Extended-release TabletsCYHS2101518 | Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2021/08/03Generic · Class 3 | Carbamazepine Extended-release TabletsCYHS2101517 | Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2021/08/03Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2101510 | Kang Pu Pharma Co., Ltd. romanized |
| 2021/08/03Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2101509 | Kang Pu Pharma Co., Ltd. romanized |
| 2021/08/03Generic · Class 3 | Calcitriol Oral SolutionCYHS2101503 | Xinjiang Te Feng Pharma Co., Ltd. romanized |
| 2021/08/03Generic · Class 3 | Famciclovir TabletsCYHS2101501 | Di Sha Pharma Group Co., Ltd. romanized |
| 2021/08/03Generic · Class 3 | 富马酸替诺福韦二吡呋酯颗粒 · No verified English nameCYHS2101480 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2021/08/03New drug · Class 3.4 | 重组人II型肿瘤坏死因子受体-抗体融合蛋白注射液 · No verified English nameCXSS2101018 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/08/03New drug · Class 3.4 | 重组人II型肿瘤坏死因子受体-抗体融合蛋白注射液 · No verified English nameCXSS2101017 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/08/03New drug · Class 3.3 | 贝伐珠单抗注射液 · No verified English nameCXSS2101016 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2021/08/03New drug · Class 3.4 | 重组人II型肿瘤坏死因子受体-抗体融合蛋白注射液 · No verified English nameCXSS2101013 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/08/03New drug · Class 1 | AK117注射液 · No verified English nameCXSL2101236 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/08/03New drug · Class 1 | AK112注射液 · No verified English nameCXSL2101235 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/08/03New drug · Class 1 | 注射用金纳单抗 · No verified English nameCXSL2101234 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2021/08/03New drug · Class 1 | SI-B001双特异性抗体注射液 · No verified English nameCXSL2101233 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2021/08/03New drug · Class 1 | SI-B001双特异性抗体注射液 · No verified English nameCXSL2101232 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2021/08/03New drug · Class 1 | 注射用CAN103 · No verified English nameCXSL2101231 | Bei Hai Kang Cheng (Suzhou) Biopharmaceutical Co., Ltd. romanized |
| 2021/08/03New drug · Class 1 | SHR-1701注射液 · No verified English nameCXSL2101230 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/08/03New drug · Class 3.3 | 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2101229 | Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized |
| 2021/08/03New drug · Class 1 | 重组人源化抗PCSK9单克隆抗体注射液 · No verified English nameCXSL2101227 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/08/03New drug · Class 1 | 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2101225 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/08/03New drug · Class 1 | 注射用SHR-A2009 · No verified English nameCXSL2101222 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/08/03New drug · Class 2.2 | 他达拉非口溶膜 · No verified English nameCXHS2101034 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
42 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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